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A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa.

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ClinicalTrials.gov Identifier: NCT03248531
Recruitment Status : Completed
First Posted : August 14, 2017
Results First Posted : February 9, 2022
Last Update Posted : April 11, 2022
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hidradenitis Suppurativa
Interventions Drug: Bimekizumab
Drug: Adalimumab
Other: Placebo
Enrollment 90
Recruitment Details The study started to enroll patients in September 2017 and concluded in February 2019.
Pre-assignment Details The study included a Screening Period (≥ 2 weeks up to a maximum of 4 weeks prior to randomization), a Treatment Period (12 weeks), and a Safety Follow-Up (SFU) Visit (20 weeks after the last dose of investigational medicinal product (IMP)). Participant Flow refers to the Randomized Set.
Arm/Group Title Placebo Adalimumab Bimekizumab
Hide Arm/Group Description Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding. Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding. Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding.
Period Title: Overall Study
Started [1] 22 22 46
Completed Week 12 [2] 19 18 42
Completed [3] 18 17 38
Not Completed 4 5 8
Reason Not Completed
Adverse Event             0             0             1
Lost to Follow-up             1             0             5
Withdrawal by Subject             3             3             2
Sponsor Request             0             2             0
[1]
Completed screening period (2-4 Weeks) and Randomized
[2]
Completed treatment period (12 Weeks)
[3]
Study completed (including safety follow-up period [20 weeks after last dose])
Arm/Group Title Placebo Adalimumab Bimekizumab Total Title
Hide Arm/Group Description Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding. Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding. Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding. [Not Specified]
Overall Number of Baseline Participants 22 22 46 90
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Randomized Set (RS) which consisted of all study participants randomized into the study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 46 participants 90 participants
<=18 years
0
   0.0%
0
   0.0%
2
   4.3%
2
   2.2%
Between 18 and 65 years
21
  95.5%
22
 100.0%
44
  95.7%
87
  96.7%
>=65 years
1
   4.5%
0
   0.0%
0
   0.0%
1
   1.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 22 participants 46 participants 90 participants
40.7  (12.5) 31.0  (9.2) 37.4  (11.9) 36.6  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 46 participants 90 participants
Female
15
  68.2%
18
  81.8%
30
  65.2%
63
  70.0%
Male
7
  31.8%
4
  18.2%
16
  34.8%
27
  30.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 46 participants 90 participants
American Indian or Alaskan Native
1
   4.5%
0
   0.0%
0
   0.0%
1
   1.1%
Asian
1
   4.5%
3
  13.6%
0
   0.0%
4
   4.4%
Black or African American
6
  27.3%
5
  22.7%
10
  21.7%
21
  23.3%
White
12
  54.5%
14
  63.6%
35
  76.1%
61
  67.8%
Other or Mixed
2
   9.1%
0
   0.0%
1
   2.2%
3
   3.3%
1.Primary Outcome
Title Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
Hide Description HiSCR was defined as at least a 50 % reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining fistula count. Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Participants with missing data at Week 12 were considered as nonresponders in the analysis. Posterior mean response rates and 95% credible intervals in each group are presented.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Per-Protocol Set (PPS) was a subset of the Full Analysis Set (FAS), consisting of those study participants who had no important protocol deviations affecting the primary efficacy variable, as confirmed during a pre-analysis review prior to unblinding of the data (at each of the interim and final analyses).
Arm/Group Title Placebo (PPS) Adalimumab (PPS) Bimekizumab (PPS)
Hide Arm/Group Description:
Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Per-Protocol Set (PPS).
Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the PPS.
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PPS.
Overall Number of Participants Analyzed 20 20 44
Mean (95% Confidence Interval)
Unit of Measure: Percentage of responders
26.1
(13.8 to 40.5)
59.5
(44.2 to 73.9)
57.3
(42.4 to 71.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (PPS), Bimekizumab (PPS)
Comments Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model. 95% credible intervals were presented for the bimekizumab (BKZ) vs placebo (PBO) comparison.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean posterior difference
Estimated Value 31.2
Confidence Interval (2-Sided) 95%
11.0 to 50.4
Parameter Dispersion
Type: Standard Deviation
Value: 10.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adalimumab (PPS), Bimekizumab (PPS)
Comments Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model. 60% credible intervals were presented for the BKZ vs adalimumab (ADA) comparison.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean posterior difference
Estimated Value -2.2
Confidence Interval (2-Sided) 60%
-11.2 to 6.6
Parameter Dispersion
Type: Standard Deviation
Value: 10.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (PPS), Bimekizumab (PPS)
Comments Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Pr [Diff>0%] (%)
Estimated Value 99.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Adalimumab (PPS), Bimekizumab (PPS)
Comments Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Pr[Diff > 0%](%)
Estimated Value 42.1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Bimekizumab Plasma Concentration at Day 1 (Prior to First Dose)
Hide Description Plasma concentration of Bimekizumab was expressed in nanograms per milliliter (ng/mL). Values Below Limit of Quantification (BLQ) were replaced by value of Lower Limit of Quantification (LLOQ) divided by 2 (75 ng/mL) in calculations of Means and Coefficient of Variations (CVs).
Time Frame Day 1 (Prior to first dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration.
Arm/Group Title Bimekizumab (PK-PPS)
Hide Arm/Group Description:
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the Pharmacokinetic Per-Protocol Set (PK-PPS).
Overall Number of Participants Analyzed 46
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
NA [1] 
(NA%)
[1]
Here, NA signifies that geometric means and geometric CVs were only calculated if at least 2/3 of the concentrations were above lower limit of quantification (LLOQ).
3.Secondary Outcome
Title Bimekizumab Plasma Concentration at Week 2
Hide Description Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.
Arm/Group Title Bimekizumab (PK-PPS)
Hide Arm/Group Description:
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS.
Overall Number of Participants Analyzed 45
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
24086.4
(56.4%)
4.Secondary Outcome
Title Bimekizumab Plasma Concentration at Week 4
Hide Description Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration.
Arm/Group Title Bimekizumab (PK-PPS)
Hide Arm/Group Description:
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS.
Overall Number of Participants Analyzed 46
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
26572.6
(57.6%)
5.Secondary Outcome
Title Bimekizumab Plasma Concentration at Week 8
Hide Description Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.
Arm/Group Title Bimekizumab (PK-PPS)
Hide Arm/Group Description:
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS.
Overall Number of Participants Analyzed 43
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
30222.6
(54.5%)
6.Secondary Outcome
Title Bimekizumab Plasma Concentration at Week 12
Hide Description Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.
Arm/Group Title Bimekizumab (PK-PPS)
Hide Arm/Group Description:
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS.
Overall Number of Participants Analyzed 42
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
25319.0
(116.8%)
7.Secondary Outcome
Title Bimekizumab Plasma Concentration at Week 30
Hide Description Plasma concentration of Bimekizumab was expressed in ng/mL. Values BLQ were replaced by value of LLOQ/2 (75 ng/mL) in calculations of Means and CVs.
Time Frame Week 30
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.
Arm/Group Title Bimekizumab (PK-PPS)
Hide Arm/Group Description:
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS.
Overall Number of Participants Analyzed 35
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
NA [1] 
(NA%)
[1]
Here, NA signifies that geometric means and geometric CVs were only calculated if at least 2/3 of the concentrations were above lower limit of quantification (LLOQ).
8.Secondary Outcome
Title Percentage of Participants With at Least One Adverse Event During the Study
Hide Description An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time Frame From Screening to Safety Follow-Up (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP.
Arm/Group Title Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Overall Number of Participants Analyzed 21 21 46
Measure Type: Number
Unit of Measure: percentage of participants
61.9 71.4 71.7
9.Secondary Outcome
Title Percentage of Participants With at Least One Adverse Event Categorized by Maximum Severity During the Study
Hide Description An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. To record the intensity of an AE Investigator used the following criteria: Mild: the study participant was aware of sign or symptom (syndrome), but it did not interfere with his/her usual activities and/or was of no clinical consequence; Moderate: AE interfered with the usual activities of the study participant or it was of some clinical consequence; Severe: the study participant was unable to work normally or to carry out his/her usual activities, or the AE was of definite clinical consequence.
Time Frame From Screening to Safety Follow-Up (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP.
Arm/Group Title Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching Placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching Placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Overall Number of Participants Analyzed 21 21 46
Measure Type: Number
Unit of Measure: percentage of participants
Mild 47.6 66.7 63.0
Moderate 33.3 42.9 39.1
Severe 4.8 9.5 6.5
10.Secondary Outcome
Title Percentage of Participants With at Least One Serious Adverse Event During the Study
Hide Description A serious adverse event (SAE) was any untoward medical occurrence that at any dose: Resulted in death, was life-threatening, required in patient hospitalization or prolongation of existing hospitalisation, was a congenital anomaly or birth defect, was an infection that required treatment parenteral antibiotics, other important medical events which based on medical or scientific judgement may have jeopardised the patients, or may have required medical or surgical intervention to prevent any of the above.
Time Frame From Screening to Safety Follow-Up (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP.
Arm/Group Title Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching Placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching Placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Overall Number of Participants Analyzed 21 21 46
Measure Type: Number
Unit of Measure: percentage of participants
9.5 4.8 4.3
11.Secondary Outcome
Title Percentage of Participants With at Least One Serious Adverse Event Categorized by Severity During the Study
Hide Description A serious adverse event (SAE) was any untoward medical occurrence that at any dose: Resulted in death, was life-threatening, required in patient hospitalization or prolongation of existing hospitalization, was a congenital anomaly or birth defect, was an infection that required treatment parenteral antibiotics, other important medical events which based on medical or scientific judgement may have jeopardised the patients, or may have required medical or surgical intervention to prevent any of the above. To record the intensity of an AE Investigator used the following criteria: Mild: study participant was aware of sign or symptom (syndrome), but it did not interfere with his/her usual activities and/or was of no clinical consequence; Moderate: AE interfered with usual activities of study participant or it was of some clinical consequence; Severe: the study participant was unable to work normally or to carry out his/her usual activities, or the AE was of definite clinical consequence.
Time Frame From Screening to Safety Follow-Up (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP.
Arm/Group Title Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching Placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching Placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Overall Number of Participants Analyzed 21 21 46
Measure Type: Number
Unit of Measure: percentage of participants
Mild 0 4.8 0
Moderate 4.8 0 0
Severe 4.8 4.8 4.3
12.Secondary Outcome
Title Percentage of Participants That Withdrew Due to Adverse Events During the Study
Hide Description An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time Frame From Screening to Safety Follow-Up (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP.
Arm/Group Title Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching Placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching Placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Overall Number of Participants Analyzed 21 21 46
Measure Type: Number
Unit of Measure: percentage of participants
0 0 2.2
13.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure)
Hide Description Blood pressure was measured in millimeters of mercury (mmHg).
Time Frame From Baseline to Safety Follow-Up (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.
Arm/Group Title Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching Placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching Placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Overall Number of Participants Analyzed 18 19 38
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic Blood Pressure -2.9  (14.8) 4.5  (14.5) -0.4  (13.8)
Diastolic Blood Pressure -1.8  (8.4) -0.6  (9.1) -2.2  (11.2)
14.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate)
Hide Description Pulse rate was measured in beats per minute (beats/min).
Time Frame From Baseline to Safety Follow-Up (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.
Arm/Group Title Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching Placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching Placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Overall Number of Participants Analyzed 18 19 38
Mean (Standard Deviation)
Unit of Measure: beats/min
-1.4  (10.2) -1.8  (10.8) -1.6  (10.8)
15.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in Body Weight
Hide Description Body weight was measured in kilograms (kg).
Time Frame From Baseline to Safety Follow-Up (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.
Arm/Group Title Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Overall Number of Participants Analyzed 18 19 38
Mean (Standard Deviation)
Unit of Measure: kg
0.90  (7.39) 1.82  (3.94) 0.42  (6.89)
16.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in ECG Parameters (ECG Mean Heart Rate)
Hide Description Electrocardiogram (ECG) Mean Heart Rate was measured in beats/min.
Time Frame From Baseline to Safety Follow-Up (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.
Arm/Group Title Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Overall Number of Participants Analyzed 18 15 37
Mean (Standard Deviation)
Unit of Measure: beats/min
-2.1  (12.4) -2.1  (11.1) 1.5  (10.1)
17.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in ECG Parameters (PR Interval, QRS Duration, QT Interval, QTcF Interval)
Hide Description PR Interval, QRS duration, QT interval and QT corrected for heart rate using Fridericia's correction (QTcF) Interval were measured in milliseconds (msec).
Time Frame From Baseline to Safety Follow-Up (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.
Arm/Group Title Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Overall Number of Participants Analyzed 18 15 37
Mean (Standard Deviation)
Unit of Measure: msec
PR Interval 0.8  (18.8) 2.4  (10.5) 3.6  (18.7)
QRS duration -0.3  (7.1) 0.2  (5.2) 0.6  (7.4)
QT interval 4.8  (20.2) 4.2  (26.7) 1.8  (27.7)
QTcF Interval -11.7  (49.9) -0.3  (14.4) 2.4  (12.7)
18.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes)
Hide Description Erythrocytes was measured in number of red blood cells per liter (10^12/L).
Time Frame From Baseline to Safety Follow-Up (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.
Arm/Group Title Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Overall Number of Participants Analyzed 14 18 33
Mean (Standard Deviation)
Unit of Measure: 10^12 red blood cells per liter
0.144  (0.349) -0.151  (0.416) -0.013  (0.274)
19.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit)
Hide Description Hematocrit was measured in volume percentage (%) of red blood cells in blood.
Time Frame From Baseline to Safety Follow-Up (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.
Arm/Group Title Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Overall Number of Participants Analyzed 14 18 33
Mean (Standard Deviation)
Unit of Measure: volume % of red blood cells
2.01  (2.83) -0.81  (4.30) 0.39  (2.69)
20.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hemoglobin, Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration)
Hide Description Hemoglobin, erythrocytes mean corpuscular hemoglobin (HGB) concentration were measured in grams per liter (g/L).
Time Frame From Baseline to Safety Follow-Up (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.
Arm/Group Title Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Overall Number of Participants Analyzed 14 18 33
Mean (Standard Deviation)
Unit of Measure: g/L
Hemoglobin 5.3  (11.6) -3.7  (11.6) 1.1  (7.6)
Erythrocytes mean corpuscular HGB -1.4  (16.2) -2.6  (13.4) -0.2  (13.2)
21.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
Hide Description Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg).
Time Frame From Baseline to Safety Follow-Up (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.
Arm/Group Title Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Overall Number of Participants Analyzed 14 18 33
Mean (Standard Deviation)
Unit of Measure: picograms (pg)
0.29  (0.76) 0.21  (0.78) 0.30  (0.99)
22.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume)
Hide Description Erythrocytes mean corpuscular volume was measured in femtoliters (fL).
Time Frame From Baseline to Safety Follow-Up (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.
Arm/Group Title Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Overall Number of Participants Analyzed 14 18 33
Mean (Standard Deviation)
Unit of Measure: femtoliters (fL)
1.49  (2.95) 1.36  (3.21) 1.04  (4.03)
23.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets)
Hide Description Platelets was measured in number of platelets per liter (10^9/L).
Time Frame From Baseline to Safety Follow-Up (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.
Arm/Group Title Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Overall Number of Participants Analyzed 14 18 33
Mean (Standard Deviation)
Unit of Measure: 10^9 platelets per liter
-17.4  (38.7) 2.3  (61.6) -19.2  (51.4)
24.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils)
Hide Description Leukocytes, basophils, eosinophils, lymphocytes, monocytes and neutrophils were measured in number of white blood cells per liter (10^9/L).
Time Frame From Baseline to Safety Follow-Up (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.
Arm/Group Title Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Overall Number of Participants Analyzed 14 18 33
Mean (Standard Deviation)
Unit of Measure: 10^9 white blood cells per liter
Leukocytes -0.281  (2.621) -0.114  (2.997) -0.122  (2.308)
Basophils 0.009  (0.026) 0.033  (0.077) 0.015  (0.048)
Eosinophils 0.007  (0.077) -0.012  (0.100) 0.002  (0.056)
Lymphocytes 0.029  (0.812) 0.241  (0.682) 0.038  (0.570)
Monocytes 0.072  (0.420) -0.032  (0.322) 0.060  (0.192)
Neutrophils -0.396  (2.076) -0.341  (2.460) -0.240  (2.234)
25.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes)
Hide Description Basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes and neutrophils/leukocytes were measured in percentages (%).
Time Frame From Baseline to Safety Follow-Up (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.
Arm/Group Title Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Overall Number of Participants Analyzed 14 18 33
Mean (Standard Deviation)
Unit of Measure: % of white blood cells per leukocytes
Basophils/leukocytes 0.13  (0.23) 0.42  (0.93) 0.13  (0.65)
Eosinophils/leukocytes -0.12  (1.92) -0.03  (1.09) 0.12  (1.12)
Lymphocytes/leukocytes 1.43  (5.47) 2.04  (6.73) 2.04  (8.07)
Monocytes/leukocytes 0.49  (4.35) -0.20  (2.79) 1.00  (2.17)
Neutrophils/leukocytes -1.93  (6.84) -2.24  (7.50) -3.29  (9.55)
26.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Bicarbonate, Chloride, Potassium, Sodium, Calcium, Magnesium, Urea Nitrogen, Cholesterol, Glucose)
Hide Description Bicarbonate, chloride, potassium, sodium, calcium, magnesium, urea nitrogen, cholesterol and glucose were measured in millimoles per liter (mmol/L).
Time Frame From Baseline to Safety Follow-Up (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.
Arm/Group Title Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Overall Number of Participants Analyzed 15 19 36
Mean (Standard Deviation)
Unit of Measure: mmol/L
Bicarbonate -0.1  (2.1) 0.7  (2.8) 0.6  (2.3)
Chloride 0.9  (1.5) 1.3  (2.4) 0.1  (2.2)
Potassium -0.13  (0.79) -0.09  (0.37) 0.03  (0.41)
Sodium 0.4  (1.5) 0.4  (1.6) 0.1  (2.2)
Calcium 0.027  (0.065) 0.008  (0.144) 0.067  (0.095)
Magnesium -0.029  (0.087) -0.027  (0.052) -0.009  (0.081)
Urea nitrogen 0.00  (1.46) -0.43  (1.37) 0.29  (1.79)
Cholesterol -0.311  (0.667) -0.177  (0.634) 0.157  (0.585)
Glucose 1.049  (1.835) 0.436  (2.990) 0.439  (2.212)
27.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin, Urate)
Hide Description Creatinine, bilirubin, and urate were measured in micromols per liter (μmol/L).
Time Frame From Baseline to Safety Follow-Up (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure and 'n' (Number analyzed) signifies participants who were evaluable for each parameter.
Arm/Group Title Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Overall Number of Participants Analyzed 15 19 36
Mean (Standard Deviation)
Unit of Measure: μmol/L
Creatinine Number Analyzed 15 participants 19 participants 36 participants
-1.73  (9.92) -1.72  (9.04) 3.84  (9.22)
Bilirubin Number Analyzed 15 participants 19 participants 34 participants
0.17  (3.48) -1.38  (3.04) 0.18  (4.35)
Urate Number Analyzed 15 participants 19 participants 34 participants
8.7  (52.2) -8.9  (50.5) 1.5  (43.1)
28.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein High Sensitivity)
Hide Description C reactive protein high sensitivity was measured in milligrams per liter (mg/L).
Time Frame From Baseline to Safety Follow-Up (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.
Arm/Group Title Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Overall Number of Participants Analyzed 15 19 36
Mean (Standard Deviation)
Unit of Measure: mg/L
-2.801  (16.851) -4.865  (21.863) -2.810  (10.853)
29.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase)
Hide Description Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase were measured in units per liter (U/L).
Time Frame From Baseline to Safety Follow-Up (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure and 'n' (Number analyzed) signifies participants who were evaluable for each parameter.
Arm/Group Title Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Overall Number of Participants Analyzed 15 19 36
Mean (Standard Deviation)
Unit of Measure: U/L
Alanine aminotransferase Number Analyzed 15 participants 19 participants 34 participants
-3.3  (8.3) -3.6  (9.8) 3.6  (23.8)
Alkaline phosphatase Number Analyzed 15 participants 19 participants 36 participants
-2.0  (12.2) -2.4  (13.5) -3.4  (11.6)
Aspartate aminotransferase Number Analyzed 15 participants 19 participants 36 participants
-0.6  (3.6) -1.0  (5.8) 2.0  (13.3)
Gamma glutamyl transferase Number Analyzed 15 participants 19 participants 36 participants
-2.0  (9.5) 1.8  (14.2) 2.3  (10.1)
Lactate dehydrogenase Number Analyzed 15 participants 19 participants 36 participants
-17.0  (29.9) -16.3  (35.6) -12.8  (61.8)
30.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine pH)
Hide Description Urine pH was measured on a pH scale.
Time Frame From Baseline to Safety Follow-Up (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.
Arm/Group Title Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Overall Number of Participants Analyzed 14 16 31
Mean (Standard Deviation)
Unit of Measure: pH
-0.43  (0.98) -0.25  (0.55) -0.03  (0.69)
31.Secondary Outcome
Title Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Albumin)
Hide Description Urine albumin was measured in milligrams per liter (mg/L).
Time Frame From Baseline to Safety Follow-Up (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all participants who were evaluable for this Outcome measure.
Arm/Group Title Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Overall Number of Participants Analyzed 15 18 34
Mean (Standard Deviation)
Unit of Measure: mg/L
50.80  (211.30) -28.25  (121.29) 0.49  (19.92)
32.Secondary Outcome
Title Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Glucose)
Hide Description [Not Specified]
Time Frame From Baseline to Safety Follow-Up (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all the participants with non-missing urinalysis results at Baseline and at Week 30 for this outcome measure.
Arm/Group Title Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Overall Number of Participants Analyzed 14 16 31
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Low - Week 30 Low
0
   0.0%
0
   0.0%
0
   0.0%
Baseline Low - Week 30 Normal
0
   0.0%
0
   0.0%
0
   0.0%
Baseline Low - Week 30 High
0
   0.0%
0
   0.0%
0
   0.0%
Baseline Normal - Week 30 Low
0
   0.0%
0
   0.0%
0
   0.0%
Baseline Normal - Week 30 Normal
12
  85.7%
14
  87.5%
28
  90.3%
Baseline Normal - Week 30 High
1
   7.1%
1
   6.3%
0
   0.0%
Baseline High - Week 30 Low
0
   0.0%
0
   0.0%
0
   0.0%
Baseline High - Week 30 Normal
0
   0.0%
1
   6.3%
1
   3.2%
Baseline High - Week 30 High
1
   7.1%
0
   0.0%
2
   6.5%
33.Secondary Outcome
Title Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Leukocyte Esterase)
Hide Description [Not Specified]
Time Frame From Baseline to Safety Follow-Up (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all the participants with non-missing urinalysis results at Baseline and at Week 30 for this outcome measure.
Arm/Group Title Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Overall Number of Participants Analyzed 14 16 31
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Low - Week 30 Low
0
   0.0%
0
   0.0%
0
   0.0%
Baseline Low - Week 30 Normal
0
   0.0%
0
   0.0%
0
   0.0%
Baseline Low - Week 30 High
0
   0.0%
0
   0.0%
0
   0.0%
Baseline Normal - Week 30 Low
0
   0.0%
0
   0.0%
0
   0.0%
Baseline Normal - Week 30 Normal
8
  57.1%
9
  56.3%
19
  61.3%
Baseline Normal - Week 30 High
2
  14.3%
0
   0.0%
6
  19.4%
Baseline High - Week 30 Low
0
   0.0%
0
   0.0%
0
   0.0%
Baseline High - Week 30 Normal
2
  14.3%
3
  18.8%
6
  19.4%
Baseline High - Week 30 High
2
  14.3%
4
  25.0%
0
   0.0%
34.Secondary Outcome
Title Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Bacteria)
Hide Description [Not Specified]
Time Frame From Baseline to Safety Follow-Up (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all the participants with non-missing urinalysis results at Baseline and at Week 30 for this outcome measure.
Arm/Group Title Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Overall Number of Participants Analyzed 3 6 2
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Low - Week 30 Low
0
   0.0%
0
   0.0%
0
   0.0%
Baseline Low - Week 30 Normal
0
   0.0%
0
   0.0%
0
   0.0%
Baseline Low - Week 30 High
0
   0.0%
0
   0.0%
0
   0.0%
Baseline Normal - Week 30 Low
0
   0.0%
0
   0.0%
0
   0.0%
Baseline Normal - Week 30 Normal
0
   0.0%
0
   0.0%
0
   0.0%
Baseline Normal - Week 30 High
0
   0.0%
0
   0.0%
0
   0.0%
Baseline High - Week 30 Low
0
   0.0%
0
   0.0%
0
   0.0%
Baseline High - Week 30 Normal
0
   0.0%
0
   0.0%
0
   0.0%
Baseline High - Week 30 High
3
 100.0%
6
 100.0%
2
 100.0%
35.Secondary Outcome
Title Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (Urine Erythrocytes)
Hide Description [Not Specified]
Time Frame From Baseline to Safety Follow-Up (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all the participants with non-missing urinalysis results at Baseline and at Week 30 for this outcome measure.
Arm/Group Title Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Overall Number of Participants Analyzed 3 1 1
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Low - Week 30 Low
0
   0.0%
0
   0.0%
0
   0.0%
Baseline Low - Week 30 Normal
0
   0.0%
0
   0.0%
0
   0.0%
Baseline Low - Week 30 High
0
   0.0%
0
   0.0%
0
   0.0%
Baseline Normal - Week 30 Low
0
   0.0%
0
   0.0%
0
   0.0%
Baseline Normal - Week 30 Normal
1
  33.3%
0
   0.0%
1
 100.0%
Baseline Normal - Week 30 High
0
   0.0%
0
   0.0%
0
   0.0%
Baseline High - Week 30 Low
0
   0.0%
0
   0.0%
0
   0.0%
Baseline High - Week 30 Normal
0
   0.0%
0
   0.0%
0
   0.0%
Baseline High - Week 30 High
2
  66.7%
1
 100.0%
0
   0.0%
36.Secondary Outcome
Title Number of Participants Who Shifted From Baseline Until Safety Follow-up Visit in Physical Examination
Hide Description [Not Specified]
Time Frame From Baseline to Safety Follow-Up (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all study participants who received at least 1 dose (full or partial) of IMP. Here, number of participants analyzed included all the participants with a normal/at least one abnormal physical examination assessment and with non-missing physical examination assessment results at Baseline and at Week 30 for this outcome measure.
Arm/Group Title Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Hide Arm/Group Description:
Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS).
Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS.
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
Overall Number of Participants Analyzed 18 19 38
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Normal - Week 30 Normal
14
  77.8%
15
  78.9%
28
  73.7%
Baseline Normal - Week 30 Abnormal
1
   5.6%
2
  10.5%
5
  13.2%
Baseline Abnormal - Week 30 Normal
1
   5.6%
1
   5.3%
1
   2.6%
Baseline Abnormal - Week 30 Abnormal
2
  11.1%
1
   5.3%
4
  10.5%
37.Secondary Outcome
Title Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Day 1
Hide Description The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration.
Arm/Group Title Bimekizumab (PK-PPS)
Hide Arm/Group Description:
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS.
Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: percentage of participants
4.3
38.Secondary Outcome
Title Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 2
Hide Description The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, the number of participants analyzed included all participants who were evaluable with a non-missing measurement for this Outcome measure.
Arm/Group Title Bimekizumab (PK-PPS)
Hide Arm/Group Description:
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS.
Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: percentage of participants
4.4
39.Secondary Outcome
Title Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 4
Hide Description The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration.
Arm/Group Title Bimekizumab (PK-PPS)
Hide Arm/Group Description:
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS.
Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: percentage of participants
4.3
40.Secondary Outcome
Title Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 8
Hide Description The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, the number of participants analyzed included all participants who were evaluable with a non-missing measurement for this Outcome measure.
Arm/Group Title Bimekizumab (PK-PPS)
Hide Arm/Group Description:
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS.
Overall Number of Participants Analyzed 42
Measure Type: Number
Unit of Measure: percentage of participants
0
41.Secondary Outcome
Title Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 12
Hide Description The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, the number of participants analyzed included all participants who were evaluable with a non-missing measurement for this Outcome measure.
Arm/Group Title Bimekizumab (PK-PPS)
Hide Arm/Group Description:
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS.
Overall Number of Participants Analyzed 42
Measure Type: Number
Unit of Measure: percentage of participants
9.5
42.Secondary Outcome
Title Percentage of Participants With Positive Bimekizumab Anti-drug Antibody (ADA) Concentration at Week 30
Hide Description The overall status of a study participant was 'Positive' if at any post-Baseline visit the result was positive. Percentages were based on the number of study participants with a non-missing measurement, from samples that did not contain BKZ concentration levels above the drug tolerance, at the visit.
Time Frame Week 30
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all randomized study participants who received at least 1 dose of investigational medicinal product (IMP) and had at least 1 quantifiable postdose plasma concentration. Here, the number of participants analyzed included all participants who were evaluable with a non-missing measurement for this Outcome measure.
Arm/Group Title Bimekizumab (PK-PPS)
Hide Arm/Group Description:
Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the PK-PPS.
Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: percentage of participants
13.9
Time Frame Treatment-emergent adverse events (TEAEs) were collected from Baseline (Day 1) until the Safety Follow-Up Visit (Week 30)
Adverse Event Reporting Description A treatment-emergent AE (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.
 
Arm/Group Title Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Hide Arm/Group Description Participants received matching placebo subcutaneous (SC) injections at Baseline, followed by Week 2, 4, 5, 6, 7, 8, 9, and 10 to maintain study blinding, forming the Safety Set (SS). Participants received one adalimumab 160 milligrams (mg) SC injection as loading dose started from Baseline, followed by adalimumab 80 mg SC injection at Week 2 and adalimumab 40 mg SC injections from Weeks 4 to 10. Participants also received matching placebo SC injection at Week 4, 6, 8 and 10 to maintain study blinding, forming the SS. Participants received one bimekizumab 640 mg SC injection as loading dose started from Baseline, followed by bimekizumab 320 mg SC injections at Weeks 2, 4, 6, 8 and 10. Participants also received matching placebo SC injections at Week 5, 7 and 9 to maintain study blinding, forming the SS.
All-Cause Mortality
Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)      0/21 (0.00%)      0/46 (0.00%)    
Hide Serious Adverse Events
Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/21 (9.52%)      1/21 (4.76%)      2/46 (4.35%)    
Blood and lymphatic system disorders       
Anaemia * 1  0/21 (0.00%)  0 0/21 (0.00%)  0 1/46 (2.17%)  1
Cardiac disorders       
Myocardial infarction * 1  1/21 (4.76%)  1 0/21 (0.00%)  0 0/46 (0.00%)  0
Infections and infestations       
Empyema * 1  0/21 (0.00%)  0 0/21 (0.00%)  0 1/46 (2.17%)  1
Nervous system disorders       
Headache * 1  1/21 (4.76%)  1 0/21 (0.00%)  0 0/46 (0.00%)  0
Dizziness * 1  1/21 (4.76%)  1 0/21 (0.00%)  0 0/46 (0.00%)  0
Hypoaesthesia * 1  1/21 (4.76%)  1 0/21 (0.00%)  0 0/46 (0.00%)  0
Skin and subcutaneous tissue disorders       
Hidradenitis * 1  0/21 (0.00%)  0 1/21 (4.76%)  2 0/46 (0.00%)  0
1
Term from vocabulary, MedDRA19.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo (SS) Adalimumab (SS) Bimekizumab (SS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/21 (23.81%)      12/21 (57.14%)      21/46 (45.65%)    
Gastrointestinal disorders       
Diarrhoea * 1  0/21 (0.00%)  0 1/21 (4.76%)  2 3/46 (6.52%)  5
Nausea * 1  0/21 (0.00%)  0 1/21 (4.76%)  1 3/46 (6.52%)  3
General disorders       
Fatigue * 1  0/21 (0.00%)  0 2/21 (9.52%)  2 4/46 (8.70%)  4
Pyrexia * 1  0/21 (0.00%)  0 2/21 (9.52%)  2 1/46 (2.17%)  2
Injection site reaction * 1  0/21 (0.00%)  0 0/21 (0.00%)  0 3/46 (6.52%)  4
Injection site pain * 1  0/21 (0.00%)  0 0/21 (0.00%)  0 3/46 (6.52%)  3
Injection site pruritus * 1  0/21 (0.00%)  0 2/21 (9.52%)  2 2/46 (4.35%)  2
Infections and infestations       
Oral candidiasis * 1  0/21 (0.00%)  0 1/21 (4.76%)  1 3/46 (6.52%)  4
Influenza * 1  0/21 (0.00%)  0 3/21 (14.29%)  3 0/46 (0.00%)  0
Nasopharyngitis * 1  0/21 (0.00%)  0 1/21 (4.76%)  1 3/46 (6.52%)  4
Upper respiratory tract infection * 1  0/21 (0.00%)  0 2/21 (9.52%)  2 2/46 (4.35%)  2
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  1/21 (4.76%)  1 2/21 (9.52%)  2 1/46 (2.17%)  3
Nervous system disorders       
Headache * 1  3/21 (14.29%)  4 0/21 (0.00%)  0 3/46 (6.52%)  4
Skin and subcutaneous tissue disorders       
Hidradenitis * 1  3/21 (14.29%)  3 6/21 (28.57%)  6 8/46 (17.39%)  9
Intertrigo * 1  0/21 (0.00%)  0 1/21 (4.76%)  1 3/46 (6.52%)  3
Vascular disorders       
Hypertension * 1  0/21 (0.00%)  0 0/21 (0.00%)  0 3/46 (6.52%)  3
1
Term from vocabulary, MedDRA19.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: +1-844-599-2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Biopharma SRL )
ClinicalTrials.gov Identifier: NCT03248531    
Other Study ID Numbers: HS0001
2017-000892-10 ( EudraCT Number )
First Submitted: August 2, 2017
First Posted: August 14, 2017
Results First Submitted: November 22, 2021
Results First Posted: February 9, 2022
Last Update Posted: April 11, 2022