A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Bimekizumab in Patients With Chronic Plaque Psoriasis

• ClinicalTrials.gov Identifier: NCT03025542
• Recruitment Status: Completed
• First Posted: January 19, 2017
• Results First Posted: January 6, 2021
• Last Update Posted: October 28, 2022
• Sponsor: UCB Biopharma SRL
• Collaborator: Parexel
• Information provided by (Responsible Party): UCB Pharma ( UCB Biopharma SRL )

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Chronic Plaque Psoriasis
• Interventions: Drug: Bimekizumab; Other: Placebo
• Enrollment: 49

Participant Flow

Recruitment Details	The study started to enroll patients in December 2016 and concluded in December 2017.
Pre-assignment Details	Participant Flow refers to the Safety Set (SS).

Arm/Group Title	Bimekizumab 320 mg + PBO	Bimekizumab 320 mg
Arm/Group Description	Bimekizumab 320 milligrams (mg) administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16.	Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16.
Period Title: Overall Study
Started	32	17
Completed	30	15
Not Completed	2	2
Reason Not Completed
Adverse Event	0	2
Lost to Follow-up	1	0
Withdrawal by Subject	1	0

Baseline Characteristics

Arm/Group Title		Bimekizumab 320 mg + PBO	Bimekizumab 320 mg	Total Title
Arm/Group Description		Bimekizumab 320 milligrams (mg) administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16.	Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16.	[Not Specified]
Overall Number of Baseline Participants		32	17	49
Baseline Analysis Population Description		Baseline Characteristics refer to the Safety Set (SS) which consisted of all participants who received at least 1 dose of the study medication.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	32 participants	17 participants	49 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	30 93.8%	16 94.1%	46 93.9%
	>=65 years	2 6.3%	1 5.9%	3 6.1%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	32 participants	17 participants	49 participants
		41.8 (14.1)	45.9 (10.4)	43.2 (13.0)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	32 participants	17 participants	49 participants
	Female	17 53.1%	6 35.3%	23 46.9%
	Male	15 46.9%	11 64.7%	26 53.1%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	32 participants	17 participants	49 participants
	Asian	1 3.1%	4 23.5%	5 10.2%
	Black or African American	1 3.1%	0 0.0%	1 2.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	1 5.9%	1 2.0%
	White	30 93.8%	12 70.6%	42 85.7%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 28
Description	The PASI is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies. The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The percent area of involvement (BSA%) is estimated across 4 body areas; head (10%), upper limbs (20%), trunk (30%), and lower limbs (40%) and then transferred into a grade. The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5 point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
Time Frame	From Baseline to Week 28

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and have a valid measurement of the primary efficacy variable post Baseline.

Arm/Group Title	Bimekizumab 320 mg + PBO (FAS)	Bimekizumab 320 mg (FAS)
Arm/Group Description:	Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).	Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).
Overall Number of Participants Analyzed	32	17
Mean (Standard Deviation); Unit of Measure: scores on a scale
	-10.76 (7.58)	-19.74 (8.77)

2. Primary Outcome

Title	Plasma Concentration of Bimekizumab at Baseline
Description	Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
Time Frame	at Baseline

Outcome Measure Data

Analysis Population Description

The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Baseline.

Arm/Group Title	Bimekizumab 320 mg + PBO (PK-PPS)	Bimekizumab 320 mg (PK-PPS)
Arm/Group Description:	Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).	Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).
Overall Number of Participants Analyzed	32	17
Geometric Mean (95% Confidence Interval); Unit of Measure: μg/mL
	NA [1]; (NA to NA)	NA [1]; (NA to NA)

[1]

Values were below the level of detection; Participants had no prior BKZ treatment.

3. Primary Outcome

Title	Plasma Concentration of Bimekizumab at Week 2
Description	Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
Time Frame	at Week 2

Outcome Measure Data

Analysis Population Description

The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 2.

Arm/Group Title	Bimekizumab 320 mg + PBO (PK-PPS)	Bimekizumab 320 mg (PK-PPS)
Arm/Group Description:	Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).	Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).
Overall Number of Participants Analyzed	32	16
Geometric Mean (95% Confidence Interval); Unit of Measure: μg/mL
	19.749; (17.0 to 23.0)	14.437; (10.8 to 19.3)

4. Primary Outcome

Title	Plasma Concentration of Bimekizumab at Week 4
Description	Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
Time Frame	at Week 4

Outcome Measure Data

Analysis Population Description

The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 4.

Arm/Group Title	Bimekizumab 320 mg + PBO (PK-PPS)	Bimekizumab 320 mg (PK-PPS)
Arm/Group Description:	Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).	Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).
Overall Number of Participants Analyzed	31	17
Geometric Mean (95% Confidence Interval); Unit of Measure: μg/mL
	11.402; (9.7 to 13.4)	9.077; (7.2 to 11.5)

5. Primary Outcome

Title	Plasma Concentration of Bimekizumab at Week 8
Description	Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
Time Frame	at Week 8

Outcome Measure Data

Analysis Population Description

The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 8.

Arm/Group Title	Bimekizumab 320 mg + PBO (PK-PPS)	Bimekizumab 320 mg (PK-PPS)
Arm/Group Description:	Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).	Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).
Overall Number of Participants Analyzed	31	16
Geometric Mean (95% Confidence Interval); Unit of Measure: μg/mL
	16.728; (14.4 to 19.5)	13.969; (11.1 to 17.6)

6. Primary Outcome

Title	Plasma Concentration of Bimekizumab at Week 12
Description	Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
Time Frame	at Week 12

Outcome Measure Data

Analysis Population Description

The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 12.

Arm/Group Title	Bimekizumab 320 mg + PBO (PK-PPS)	Bimekizumab 320 mg (PK-PPS)
Arm/Group Description:	Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).	Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).
Overall Number of Participants Analyzed	31	15
Geometric Mean (95% Confidence Interval); Unit of Measure: μg/mL
	5.972; (4.9 to 7.3)	5.466; (3.9 to 7.7)

7. Primary Outcome

Title	Plasma Concentration of Bimekizumab at Week 16
Description	Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (µg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
Time Frame	at Week 16

Outcome Measure Data

Analysis Population Description

The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 16.

Arm/Group Title	Bimekizumab 320 mg + PBO (PK-PPS)	Bimekizumab 320 mg (PK-PPS)
Arm/Group Description:	Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).	Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).
Overall Number of Participants Analyzed	31	15
Geometric Mean (95% Confidence Interval); Unit of Measure: µg/mL
	2.200; (1.6 to 3.0)	2.293; (1.4 to 3.7)

8. Primary Outcome

Title	Plasma Concentration of Bimekizumab at Week 20
Description	Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
Time Frame	at Week 20

Outcome Measure Data

Analysis Population Description

The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 20.

Arm/Group Title	Bimekizumab 320 mg + PBO (PK-PPS)	Bimekizumab 320 mg (PK-PPS)
Arm/Group Description:	Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).	Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).
Overall Number of Participants Analyzed	31	15
Geometric Mean (95% Confidence Interval); Unit of Measure: μg/mL
	0.798; (0.5 to 1.2)	9.702; (7.3 to 13.0)

9. Primary Outcome

Title	Plasma Concentration of Bimekizumab at Week 24
Description	Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
Time Frame	at Week 24

Outcome Measure Data

Analysis Population Description

The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 24.

Arm/Group Title	Bimekizumab 320 mg + PBO (PK-PPS)	Bimekizumab 320 mg (PK-PPS)
Arm/Group Description:	Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).	Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).
Overall Number of Participants Analyzed	29	15
Geometric Mean (95% Confidence Interval); Unit of Measure: μg/mL
	NA [1]; (NA to NA)	4.377; (3.2 to 6.0)

[1]

Values were below the level of detection.

10. Primary Outcome

Title	Plasma Concentration of Bimekizumab at Week 28
Description	Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
Time Frame	at Week 28

Outcome Measure Data

Analysis Population Description

The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 28.

Arm/Group Title	Bimekizumab 320 mg + PBO (PK-PPS)	Bimekizumab 320 mg (PK-PPS)
Arm/Group Description:	Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).	Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).
Overall Number of Participants Analyzed	26	13
Geometric Mean (95% Confidence Interval); Unit of Measure: μg/mL
	NA [1]; (NA to NA)	1.933; (1.2 to 3.1)

[1]

Values were below the level of detection.

11. Primary Outcome

Title	Plasma Concentration of Bimekizumab at Week 36
Description	Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
Time Frame	at Week 36

Outcome Measure Data

Analysis Population Description

The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 36.

Arm/Group Title	Bimekizumab 320 mg + PBO (PK-PPS)	Bimekizumab 320 mg (PK-PPS)
Arm/Group Description:	Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).	Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).
Overall Number of Participants Analyzed	24	14
Geometric Mean (95% Confidence Interval); Unit of Measure: μg/mL
	NA [1]; (NA to NA)	0.322; (0.2 to 0.6)

[1]

Values were below the level of detection.

12. Primary Outcome

Title	Percentage of Participants Reporting Positive Anti-Drug-Antibodies (ADA) Titre Prior to Study Treatment With Bimekizumab at Baseline
Description	An ADA status of positive was concluded for any participant with an ADA level that was above cut point (ACP) and 'confirmed positive' (CP) at any time point. A participant was classified as having treatment-induced ADA positivity when meeting one of the following criteria: -The Baseline result was either below cut point (BCP) or ACP and 'not confirmed positive' (NCP), and at least 1 post Baseline time point was ACP and CP. -The Baseline result was positive (ACP and CP) and at least one post-Baseline measurement showed a pre-defined fold increase in titre from the Baseline value. Note: The overall status of a participant is 'Positive' if at any post-Baseline visit the result was ACP and confirmed positive.
Time Frame	at Baseline

Outcome Measure Data

Analysis Population Description

The Safety Set (SS) consisted of all participants who received at least 1 dose of the study medication. Percentages were based on the number of participants with a non-missing measurement at Baseline.

Arm/Group Title	Bimekizumab 320 mg + PBO (SS)	Bimekizumab 320 mg (SS)
Arm/Group Description:	Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Safety Set (SS).	Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Safety Set (SS).
Overall Number of Participants Analyzed	32	17
Measure Type: Number; Unit of Measure: percentage of participants
	3.1	0

13. Primary Outcome

Title	Percentage of Participants Reporting an Overall Positive Anti-Drug-Antibodies (ADA) Titre Following Study Treatment With Bimekizumab
Description	An ADA status of positive was concluded for any participant with an ADA level that was above cut point (ACP) and 'confirmed positive' (CP) at any time point. A participant was classified as having treatment-induced ADA positivity when meeting one of the following criteria: -The Baseline result was either below cut point (BCP) or ACP and 'not confirmed positive' (NCP), and at least 1 post Baseline time point was ACP and CP. -The Baseline result was positive (ACP and CP) and at least one post-Baseline measurement showed a pre-defined fold increase in titre from the Baseline value. Note: The overall status of a participant is 'Positive' if at any post-Baseline visit the result was ACP and confirmed positive.
Time Frame	From Baseline to Safety Follow-Up Visit (Week 36)

Outcome Measure Data

Analysis Population Description

The Safety Set (SS) consisted of all participants who received at least 1 dose of the study medication.

Arm/Group Title	Bimekizumab 320 mg + PBO (SS)	Bimekizumab 320 mg (SS)
Arm/Group Description:	Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Safety Set (SS).	Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Safety Set (SS).
Overall Number of Participants Analyzed	32	17
Measure Type: Number; Unit of Measure: percentage of participants
	34.4	47.1

14. Primary Outcome

Title	Percentage of Participants Who Experienced at Least One Adverse Events (AEs)
Description	An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. Within the Safety Set, this trial reported a total of 164 occurences of adverse events, of which 7 were pre-treatment adverse events and 157 were treatment-emergent adverse events (TEAEs).
Time Frame	From Screening to Safety Follow-Up Visit (Week 36)

Outcome Measure Data

Analysis Population Description

The Safety Set (SS) consisted of all participants who received at least 1 dose of the study medication.

Arm/Group Title	Bimekizumab 320 mg + PBO (SS)	Bimekizumab 320 mg (SS)
Arm/Group Description:	Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Safety Set (SS).	Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Safety Set (SS).
Overall Number of Participants Analyzed	32	17
Measure Type: Number; Unit of Measure: percentage of participants
	87.5	88.2

15. Secondary Outcome

Title	Percentage of Participants Achieving a 75% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16
Description	The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time Frame	From Baseline to Week 16

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and have a valid measurement of the primary efficacy variable post Baseline.

Arm/Group Title	Bimekizumab 320 mg + PBO (FAS)	Bimekizumab 320 mg (FAS)
Arm/Group Description:	Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).	Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).
Overall Number of Participants Analyzed	32	17
Measure Type: Number; Unit of Measure: percentage of participants
	93.8	88.2

16. Secondary Outcome

Title	Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16
Description	The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time Frame	From Baseline to Week 16

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and have a valid measurement of the primary efficacy variable post Baseline.

Arm/Group Title	Bimekizumab 320 mg + PBO (FAS)	Bimekizumab 320 mg (FAS)
Arm/Group Description:	Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).	Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).
Overall Number of Participants Analyzed	32	17
Measure Type: Number; Unit of Measure: percentage of participants
	84.4	70.6

17. Secondary Outcome

Title	Percentage of Participants Achieving a 100% Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16
Description	The PASI100 response assessments are based on at least 100% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time Frame	From Baseline to Week 16

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and have a valid measurement of the primary efficacy variable post Baseline.

Arm/Group Title	Bimekizumab 320 mg + PBO (FAS)	Bimekizumab 320 mg (FAS)
Arm/Group Description:	Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).	Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).
Overall Number of Participants Analyzed	32	17
Measure Type: Number; Unit of Measure: percentage of participants
	46.9	52.9

18. Secondary Outcome

Title	Percentage of Participants With IGA (Investigator´s Global Assessment) Response at Week 16
Description	The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions.
Time Frame	at Week 16

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and have a valid measurement of the primary efficacy variable post Baseline.

Arm/Group Title	Bimekizumab 320 mg + PBO (FAS)	Bimekizumab 320 mg (FAS)
Arm/Group Description:	Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).	Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).
Overall Number of Participants Analyzed	32	17
Measure Type: Number; Unit of Measure: percentage of participants
	81.3	64.7

Adverse Events

Time Frame	From Baseline to Week 36
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Bimekizumab 320 mg + PBO (SS)		Bimekizumab 320 mg (SS)
Arm/Group Description	Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Safety Set (SS).		Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Safety Set (SS).
All-Cause Mortality
	Bimekizumab 320 mg + PBO (SS)		Bimekizumab 320 mg (SS)
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/32 (0.00%)		0/17 (0.00%)
Serious Adverse Events
	Bimekizumab 320 mg + PBO (SS)		Bimekizumab 320 mg (SS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/32 (6.25%)		1/17 (5.88%)
Gastrointestinal disorders
Pancreatitis * 1	0/32 (0.00%)	0	1/17 (5.88%)	1
Hepatobiliary disorders
Cholecystitis acute * 1	0/32 (0.00%)	0	1/17 (5.88%)	1
Nervous system disorders
Syncope * 1	1/32 (3.13%)	1	0/17 (0.00%)	0
Peripheral sensorimotor neuropathy * 1	1/32 (3.13%)	1	0/17 (0.00%)	0
1 Term from vocabulary, MedDRA19.0; * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Bimekizumab 320 mg + PBO (SS)		Bimekizumab 320 mg (SS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	28/32 (87.50%)		15/17 (88.24%)
Blood and lymphatic system disorders
Hypochromic anaemia * 1	0/32 (0.00%)	0	1/17 (5.88%)	1
Gastrointestinal disorders
Nausea * 1	1/32 (3.13%)	1	1/17 (5.88%)	1
Abdominal discomfort * 1	0/32 (0.00%)	0	1/17 (5.88%)	1
Anal pruritus * 1	0/32 (0.00%)	0	1/17 (5.88%)	1
Dental necrosis * 1	0/32 (0.00%)	0	1/17 (5.88%)	1
Irritable bowel syndrome * 1	0/32 (0.00%)	0	1/17 (5.88%)	1
Hepatobiliary disorders
Non-alcoholic fatty liver * 1	0/32 (0.00%)	0	1/17 (5.88%)	1
Immune system disorders
Seasonal allergy * 1	0/32 (0.00%)	0	1/17 (5.88%)	2
Infections and infestations
Upper respiratory tract infection * 1	6/32 (18.75%)	8	3/17 (17.65%)	3
Nasopharyngitis * 1	2/32 (6.25%)	2	4/17 (23.53%)	4
Urinary tract infection * 1	4/32 (12.50%)	4	0/17 (0.00%)	0
Viral upper respiratory tract infection * 1	2/32 (6.25%)	2	2/17 (11.76%)	3
Gastroenteritis viral * 1	2/32 (6.25%)	2	1/17 (5.88%)	1
Oral candidiasis * 1	2/32 (6.25%)	2	0/17 (0.00%)	0
Viral infection * 1	0/32 (0.00%)	0	2/17 (11.76%)	2
Bacterial diarrhoea * 1	0/32 (0.00%)	0	1/17 (5.88%)	1
Conjunctivitis * 1	0/32 (0.00%)	0	1/17 (5.88%)	1
Conjunctivitis bacterial * 1	0/32 (0.00%)	0	1/17 (5.88%)	1
Ear infection * 1	0/32 (0.00%)	0	1/17 (5.88%)	1
Localised infection * 1	0/32 (0.00%)	0	1/17 (5.88%)	1
Postoperative wound infection * 1	0/32 (0.00%)	0	1/17 (5.88%)	1
Investigations
Alanine aminotransferase increased * 1	2/32 (6.25%)	3	3/17 (17.65%)	3
Gamma-glutamyltransferase increased * 1	2/32 (6.25%)	4	3/17 (17.65%)	7
Aspartate aminotransferase increased * 1	2/32 (6.25%)	2	2/17 (11.76%)	4
Neutrophil count decreased * 1	1/32 (3.13%)	1	3/17 (17.65%)	3
Blood cholesterol increased * 1	1/32 (3.13%)	1	2/17 (11.76%)	2
Blood bilirubin increased * 1	0/32 (0.00%)	0	1/17 (5.88%)	1
Lymphocyte count decreased * 1	0/32 (0.00%)	0	1/17 (5.88%)	1
Mean cell haemoglobin concentration decreased * 1	0/32 (0.00%)	0	1/17 (5.88%)	1
Platelet count decreased * 1	0/32 (0.00%)	0	1/17 (5.88%)	3
Metabolism and nutrition disorders
White blood cell count decreased * 1	2/32 (6.25%)	2	3/17 (17.65%)	5
Hyperkalaemia * 1	4/32 (12.50%)	6	1/17 (5.88%)	1
Musculoskeletal and connective tissue disorders
Arthralgia * 1	1/32 (3.13%)	1	1/17 (5.88%)	1
Back pain * 1	1/32 (3.13%)	1	1/17 (5.88%)	1
Neck pain * 1	0/32 (0.00%)	0	1/17 (5.88%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis * 1	0/32 (0.00%)	0	1/17 (5.88%)	2
Nervous system disorders
Headache * 1	3/32 (9.38%)	3	1/17 (5.88%)	1
Tension headache * 1	0/32 (0.00%)	0	1/17 (5.88%)	1
Respiratory, thoracic and mediastinal disorders
Cough * 1	0/32 (0.00%)	0	1/17 (5.88%)	1
Skin and subcutaneous tissue disorders
Pruritus generalised * 1	1/32 (3.13%)	1	1/17 (5.88%)	1
Psoriasis * 1	1/32 (3.13%)	1	1/17 (5.88%)	1
Dermatitis * 1	0/32 (0.00%)	0	1/17 (5.88%)	1
1 Term from vocabulary, MedDRA19.0; * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: UCB
• Organization: Cares
• Phone: 001 844 599 2273
• EMail: UCBCares@ucb.com

Publications of Results:

Oliver R, Krueger JG, Glatt S, Vajjah P, Mistry C, Page M, Edwards H, Garcet S, Li X, Dizier B, Maroof A, Watling M, El Baghdady A, Baeten D, Ionescu L, Shaw S. Bimekizumab for the treatment of moderate-to-severe plaque psoriasis: efficacy, safety, pharmacokinetics, pharmacodynamics and transcriptomics from a phase IIa, randomized, double-blind multicentre study. Br J Dermatol. 2022 Apr;186(4):652-663. doi: 10.1111/bjd.20827. Epub 2021 Dec 27.

Gordon KB, Langley RG, Warren RB, Okubo Y, Stein Gold L, Merola JF, Peterson L, Wixted K, Cross N, Deherder D, Thaci D. Bimekizumab Safety in Patients With Moderate to Severe Plaque Psoriasis: Pooled Results From Phase 2 and Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2022 Jul 1;158(7):735-744. doi: 10.1001/jamadermatol.2022.1185.

• Responsible Party: UCB Pharma ( UCB Biopharma SRL )
• ClinicalTrials.gov Identifier: NCT03025542
• Other Study ID Numbers: PS0016; 2016-002368-15 ( EudraCT Number )
• First Submitted: January 17, 2017
• First Posted: January 19, 2017
• Results First Submitted: December 9, 2020
• Results First Posted: January 6, 2021
• Last Update Posted: October 28, 2022