A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE RADIANT)

• ClinicalTrials.gov Identifier: NCT03536884
• Recruitment Status: Active, not recruiting
• First Posted: May 25, 2018
• Results First Posted: October 10, 2022
• Last Update Posted: February 24, 2023
• Sponsor: UCB Biopharma SRL
• 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
• Conditions: Chronic Plaque Psoriasis; Moderate to Severe Chronic Plaque Psoriasis
• Interventions: Drug: Bimekizumab; Drug: Secukinumab; Other: Placebo
• Enrollment: 743

Participant Flow

Recruitment Details	The study started to enroll study participants in June 2018.
Pre-assignment Details	The record presents interim results, up to Week 48. It includes the Double-Blind Treatment Period, consisting of Initial Treatment Period (Week 0 - 16) and Maintenance Treatment Period (Week 16 - 48). Participant flow refers to the Randomized Set (RS) for Initial Treatment Period and Maintenance Set (MS) for Maintenance Treatment Period.

Arm/Group Title	Bimekizumab (BKZ) 320 Milligrams (mg) Q4W	Secukinumab 300 mg Q4W	Bimekizumab (BKZ) 320 mg Q4W/Q8W	Bimekizumab (BKZ) 320 mg Q4W/Q4W	Secukinumab 300 mg Q4W/Q4W
Arm/Group Description	Participants randomized to this arm received bimekizumab 320 mg subcutaneously (sc) every 4 weeks (Q4W) for 16 weeks in the Initial Treatment Period. Placebo was administered at pre-specified time-points to maintain the blinding.	Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 16 in the Initial Treatment Period.	Participants randomized to this arm received bimekizumab 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. At Week 16, participants were re-randomized to receive bimekizumab 320 mg sc Q8W until Week 48 in the Maintenance Treatment Period. Placebo was administered at pre-specified time-points to maintain the blinding.	Participants randomized to this arm received bimekizumab 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. At Week 16, participants continued to receive bimekizumab 320 mg sc every 4 Weeks (Q4W/Q4W) until Week 48 in the Maintenance Treatment Period.	Participants in secukinumab arm continued to receive secukinumab 300 mg sc Q4W until Week 48 in the Maintenance Treatment Period.
Period Title: Initial Treatment Period Week 0-16
Started	373	370	0	0	0
Completed	362	354	0	0	0
Not Completed	11	16	0	0	0
Reason Not Completed
Adverse Event	8	6	0	0	0
Lost to Follow-up	0	3	0	0	0
Withdrawal by Subject	3	4	0	0	0
Unblinding was reason for dropout	0	1	0	0	0
Withdrawn by Investigator for abnormal lab values	0	1	0	0	0
Unable to attend visits	0	1	0	0	0
Period Title: Maintenance Treatment Period Week 16-48
Started	0	0	215	147	354
Completed	0	0	205	138	325
Not Completed	0	0	10	9	29
Reason Not Completed
Death	0	0	1	0	1
Adverse Event	0	0	1	3	3
Lack of Efficacy	0	0	0	1	4
Lost to Follow-up	0	0	1	2	8
Withdrawal by Subject	0	0	7	3	12
Unable to come back for study visits	0	0	0	0	1

Baseline Characteristics

Arm/Group Title		Bimekizumab (BKZ) 320 Milligrams (mg) Q4W	Secukinumab 300 mg Q4W	Total Title
Arm/Group Description		Participants randomized to this arm received bimekizumab 320 mg subcutaneously (sc) every 4 weeks (Q4W) for 16 weeks in the Initial Treatment Period. Placebo was administered at pre-specified time-points to maintain the blinding.	Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 16 in the Initial Treatment Period.	[Not Specified]
Overall Number of Baseline Participants		373	370	743
Baseline Analysis Population Description		Baseline Characteristics refer to the Randomized Set (RS) which consisted of all randomized study participants.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	373 participants	370 participants	743 participants
	<=18 years	3 0.8%	7 1.9%	10 1.3%
	Between 18 and 65 years	332 89.0%	324 87.6%	656 88.3%
	>=65 years	38 10.2%	39 10.5%	77 10.4%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	373 participants	370 participants	743 participants
		45.9 (14.2)	44.0 (14.7)	45.0 (14.5)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	373 participants	370 participants	743 participants
	Female	122 32.7%	135 36.5%	257 34.6%
	Male	251 67.3%	235 63.5%	486 65.4%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	373 participants	370 participants	743 participants
	American Indian or Alaska Native	0 0.0%	2 0.5%	2 0.3%
	Asian	10 2.7%	9 2.4%	19 2.6%
	Black or African American	6 1.6%	4 1.1%	10 1.3%
	Native Hawaiian or Other Pacific Islander	1 0.3%	1 0.3%	2 0.3%
	White	347 93.0%	348 94.1%	695 93.5%
	Other or Mixed	9 2.4%	6 1.6%	15 2.0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16
Description	The PASI100 response assessments are based on 100% improvement in PASI score from Baseline. 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 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	Week 16

Outcome Measure Data

Analysis Population Description

The Randomized Set (RS) consisted of all randomized study participants.

Arm/Group Title	Bimekizumab (BKZ) 320 mg Q4W (RS)	Secukinumab 300 mg Q4W (RS)
Arm/Group Description:	Participants randomized to this arm received bimekizumab 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. Placebo was administered at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 16 in the Initial Treatment Period. Participants formed the RS.
Overall Number of Participants Analyzed	373	370
Measure Type: Number; Unit of Measure: percentage of participants
	61.7	48.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bimekizumab (BKZ) 320 mg Q4W (RS), Secukinumab 300 mg Q4W (RS)
	Comments	Risk Difference: BKZ-Secukinumab calculated using stratified Cochran-Mantel-Haenszel (CMH).
	Type of Statistical Test	Non-Inferiority
	Comments	The evaluation of noninferiority is tested at a 1-sided alpha level of 0.025 and based on a 1-sided 97.5% CI and a noninferiority margin of 10%.
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	12.705
	Confidence Interval	(2-Sided) 95%; 5.800 to 19.610
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Bimekizumab (BKZ) 320 mg Q4W (RS), Secukinumab 300 mg Q4W (RS)
	Comments	Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-values for the comparison of treatment groups are based on the CMH test for the general association.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.715
	Confidence Interval	(2-Sided) 95%; 1.273 to 2.312
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Percentage of Participants With a PASI75 Response at Week 4
Description	The PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to 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	Week 4

Outcome Measure Data

Analysis Population Description

The Randomized Set (RS) consisted of all randomized study participants.

Arm/Group Title	Bimekizumab (BKZ) 320 mg Q4W (RS)	Secukinumab 300 mg Q4W (RS)
Arm/Group Description:	Participants randomized to this arm received bimekizumab 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. Placebo was administered at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 16 in the Initial Treatment Period. Participants formed the RS.
Overall Number of Participants Analyzed	373	370
Measure Type: Number; Unit of Measure: percentage of participants
	71.0	47.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bimekizumab (BKZ) 320 mg Q4W (RS), Secukinumab 300 mg Q4W (RS)
	Comments	Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-values for the comparison of treatment groups are based on the CMH test from the general association. P-values are not controlled for multiplicity and should only be considered descriptively.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.809
	Confidence Interval	(2-Sided) 95%; 2.064 to 3.823
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Percentage of Participants With a PASI90 Response at Week 16
Description	The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with 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 respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

The Randomized Set (RS) consisted of all randomized study participants.

Arm/Group Title	Bimekizumab (BKZ) 320 mg Q4W (RS)	Secukinumab 300 mg Q4W (RS)
Arm/Group Description:	Participants randomized to this arm received bimekizumab 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. Placebo was administered at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 16 in the Initial Treatment Period. Participants formed the RS.
Overall Number of Participants Analyzed	373	370
Measure Type: Number; Unit of Measure: percentage of participants
	85.5	74.3

4. Secondary Outcome

Title	Percentage of Participants With a PASI100 Response at Week 48
Description	The PASI100 response assessments are based on 100% improvement in PASI score from Baseline. 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 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	Week 48

Outcome Measure Data

Analysis Population Description

The Randomized Set (RS) consisted of all randomized study participants. The Maintenance Set (MS) consisted of all study participants that received at least 1 dose of IMP at Week 16 or later in the Double-Blind Treatment Period (including the Week 16 dose).

Arm/Group Title	Bimekizumab (BKZ) 320 mg Q4W (RS)	Secukinumab 300 mg Q4W (RS)	Bimekizumab (BKZ) 320 mg Q4W/Q8W (MS)	Bimekizumab (BKZ) 320 mg Q4W/Q4W (MS)	Secukinumab 300 mg Q4W/Q4W (MS)
Arm/Group Description:	Participants randomized to this arm received bimekizumab 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. Placebo was administered at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 16 in the Initial Treatment Period. Participants formed the RS.	Participants randomized to this arm received bimekizumab 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. At Week 16, participants were re-randomized to receive bimekizumab 320 mg sc Q8W until Week 48 in the Maintenance Treatment Period. Placebo was administered at pre-specified time-points to maintain the blinding. Participants formed the Maintenance set (MS).	Participants randomized to this arm received bimekizumab 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. At Week 16, participants continued to receive bimekizumab 320 mg sc every 4 Weeks (Q4W/Q4W) until Week 48 in the Maintenance Treatment Period. Participants formed the MS.	Participants in secukinumab arm continued to receive secukinumab 300 mg sc Q4W until Week 48 in the Maintenance Treatment Period. Participants formed the MS.
Overall Number of Participants Analyzed	373	370	215	147	354
Measure Type: Number; Unit of Measure: percentage of participants
	67.0	46.2	66.0	73.5	48.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bimekizumab (BKZ) 320 mg Q4W (RS), Secukinumab 300 mg Q4W (RS)
	Comments	Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-values for the comparison of treatment groups are based on the CMH test from the general association. P-values are not controlled for multiplicity and should only be considered descriptively.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.460
	Confidence Interval	(2-Sided) 95%; 1.814 to 3.336
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Bimekizumab (BKZ) 320 mg Q4W/Q8W (MS), Secukinumab 300 mg Q4W/Q4W (MS)
	Comments	Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-values for the comparison of treatment groups are based on the CMH test from the general association.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.120
	Confidence Interval	(2-Sided) 95%; 1.478 to 3.040
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Bimekizumab (BKZ) 320 mg Q4W/Q4W (MS), Secukinumab 300 mg Q4W/Q4W (MS)
	Comments	Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-values for the comparison of treatment groups are based on the CMH test from the general association.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.241
	Confidence Interval	(2-Sided) 95%; 2.103 to 4.996
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	Percentage of Participants With a Investigator´s Global Assessment (IGA) Response (0/1) at Week 16
Description	The 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. IGA response was defined as Clear (0) or Almost Clear (1) with at least a two-category improvement from Baseline at Week 16.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

The Randomized Set (RS) consisted of all randomized study participants.

Arm/Group Title	Bimekizumab (BKZ) 320 mg Q4W (RS)	Secukinumab 300 mg Q4W (RS)
Arm/Group Description:	Participants randomized to this arm received bimekizumab 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. Placebo was administered at pre-specified time-points to maintain the blinding. Participants formed the Randomized Set (RS).	Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 16 in the Initial Treatment Period. Participants formed the RS.
Overall Number of Participants Analyzed	373	370
Measure Type: Number; Unit of Measure: percentage of participants
	85.5	78.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bimekizumab (BKZ) 320 mg Q4W (RS), Secukinumab 300 mg Q4W (RS)
	Comments	Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	=0.012
	Comments	P-values for the comparison of treatment groups are based on the CMH test from the general association. P-values are not controlled for multiplicity and should only be considered descriptively.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.637
	Confidence Interval	(2-Sided) 95%; 1.113 to 2.408
	Estimation Comments	[Not Specified]

6. Secondary Outcome

Title	Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Investigational Medicinal Product (IMP) From Baseline up to Week 48
Description	The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Time Frame	From Baseline up to Week 48

Outcome Measure Data

Analysis Population Description

The Safety Set (SS) consisted of all study participants that received at least 1 dose of IMP.

Arm/Group Title	Bimekizumab (BKZ) 320 mg Q8W (Week 16 to Week 48) (SS)	Bimekizumab (BKZ) 320 mg Q4W (up to Week 48) (SS)	Secukinumab 300 mg Q4W (up to Week 48) (SS)
Arm/Group Description:	Participants who received at least one dose of bimekizumab 320 mg sc Q8W from Week 16 until Week 48. Participants formed the SS.	Participants who received at least one dose of bimekizumab 320 mg sc Q4W until Week 48. Participants formed the SS.	Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 48. Participants formed the SS.
Overall Number of Participants Analyzed	215	373	370
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: no. of new events per 100 subject-years
	251.05; (213.88 to 292.83)	331.18; (293.32 to 372.56)	229.75; (204.53 to 257.23)

7. Secondary Outcome

Title	Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 48
Description	The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Time Frame	From Baseline up to Week 48

Outcome Measure Data

Analysis Population Description

The Safety Set (SS) consisted of all study participants that received at least 1 dose of IMP.

Arm/Group Title	Bimekizumab (BKZ) 320 mg Q8W (Week 16 to Week 48) (SS)	Bimekizumab (BKZ) 320 mg Q4W (up to Week 48) (SS)	Secukinumab 300 mg Q4W (up to Week 48) (SS)
Arm/Group Description:	Participants who received at least one dose of bimekizumab 320 mg sc Q8W from Week 16 until Week 48. Participants formed the SS.	Participants who received at least one dose of bimekizumab 320 mg sc Q4W until Week 48. Participants formed the SS.	Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 48. Participants formed the SS.
Overall Number of Participants Analyzed	215	373	370
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: no. of new events per 100 subject-years
	6.94; (3.17 to 13.17)	6.34; (3.38 to 10.84)	6.45; (3.99 to 9.86)

8. Secondary Outcome

Title	Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 48
Description	The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
Time Frame	From Baseline up to Week 48

Outcome Measure Data

Analysis Population Description

The Safety Set (SS) consisted of all study participants that received at least 1 dose of IMP.

Arm/Group Title	Bimekizumab (BKZ) 320 mg Q8W (Week 16 to Week 48) (SS)	Bimekizumab (BKZ) 320 mg Q4W (up to Week 48) (SS)	Secukinumab 300 mg Q4W (up to Week 48) (SS)
Arm/Group Description:	Participants who received at least one dose of bimekizumab 320 mg sc Q8W from Week 16 until Week 48. Participants formed the SS.	Participants who received at least one dose of bimekizumab 320 mg sc Q4W until Week 48. Participants formed the SS.	Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 48. Participants formed the SS.
Overall Number of Participants Analyzed	215	373	370
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: no. of new events per 100 subject-years
	0.75; (0.02 to 4.20)	5.85; (3.02 to 10.22)	3.03; (1.45 to 5.57)

Adverse Events

Time Frame	Treatment-emergent Adverse Events (AEs) were collected from Baseline up to Week 48
Adverse Event Reporting Description	TEAEs were defined as those AEs that have a start date on or following first dose of study treatment through final dose of study treatment + 140 days (covering 20-week SFU Period). For participants that switched from BKZ 320 mg Q4W to Q8W, events prior to switch are counted in the Q4W group and events after the switch are counted in the Q8W group.
Arm/Group Title	Bimekizumab (BKZ) 320 mg Q4W (up to Week 16) (SS)		Secukinumab 300 mg Q4W (up to Week 16) (SS)		Bimekizumab (BKZ) 320 mg Q8W (Week 16 to Week 48) (SS)		Bimekizumab (BKZ) 320 mg Q4W (up to Week 48) (SS)		Secukinumab 300 mg Q4W (up to Week 48) (SS)
Arm/Group Description	Participants randomized to this arm received bimekizumab 320 mg sc Q4W for 16 weeks in the Initial Treatment Period. Placebo was administered at pre-specified time-points to maintain the blinding. Participants formed the Safety Set (SS).		Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 16 in the Initial Treatment Period. Participants formed the SS.		Participants who received at least one dose of bimekizumab 320 mg sc Q8W from Week 16 until Week 48. Participants formed the SS.		Participants who received at least one dose of bimekizumab 320 mg sc Q4W until Week 48. Participants formed the SS.		Participants received secukinumab 300 mg sc at Baseline and Weeks 1, 2, 3, and 4 followed by dosing Q4W until Week 48. Participants formed the SS.
All-Cause Mortality
	Bimekizumab (BKZ) 320 mg Q4W (up to Week 16) (SS)		Secukinumab 300 mg Q4W (up to Week 16) (SS)		Bimekizumab (BKZ) 320 mg Q8W (Week 16 to Week 48) (SS)		Bimekizumab (BKZ) 320 mg Q4W (up to Week 48) (SS)		Secukinumab 300 mg Q4W (up to Week 48) (SS)
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/373 (0.00%)		0/370 (0.00%)		1/215 (0.47%)		0/373 (0.00%)		1/370 (0.27%)
Serious Adverse Events
	Bimekizumab (BKZ) 320 mg Q4W (up to Week 16) (SS)		Secukinumab 300 mg Q4W (up to Week 16) (SS)		Bimekizumab (BKZ) 320 mg Q8W (Week 16 to Week 48) (SS)		Bimekizumab (BKZ) 320 mg Q4W (up to Week 48) (SS)		Secukinumab 300 mg Q4W (up to Week 48) (SS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/373 (2.41%)		7/370 (1.89%)		9/215 (4.19%)		13/373 (3.49%)		21/370 (5.68%)
Cardiac disorders
Coronary artery disease * 1	0/373 (0.00%)	0	0/370 (0.00%)	0	0/215 (0.00%)	0	0/373 (0.00%)	0	1/370 (0.27%)	1
Acute myocardial infarction * 1	0/373 (0.00%)	0	0/370 (0.00%)	0	0/215 (0.00%)	0	0/373 (0.00%)	0	1/370 (0.27%)	1
Atrial fibrillation * 1	0/373 (0.00%)	0	0/370 (0.00%)	0	1/215 (0.47%)	1	0/373 (0.00%)	0	2/370 (0.54%)	2
Supraventricular tachycardia * 1	0/373 (0.00%)	0	0/370 (0.00%)	0	0/215 (0.00%)	0	1/373 (0.27%)	1	0/370 (0.00%)	0
Gastrointestinal disorders
Colitis ulcerative * 1	1/373 (0.27%)	1	0/370 (0.00%)	0	0/215 (0.00%)	0	1/373 (0.27%)	1	0/370 (0.00%)	0
Inguinal hernia * 1	1/373 (0.27%)	1	0/370 (0.00%)	0	0/215 (0.00%)	0	1/373 (0.27%)	1	0/370 (0.00%)	0
Pancreatitis * 1	0/373 (0.00%)	0	0/370 (0.00%)	0	0/215 (0.00%)	0	0/373 (0.00%)	0	1/370 (0.27%)	1
Pancreatitis acute * 1	0/373 (0.00%)	0	0/370 (0.00%)	0	0/215 (0.00%)	0	0/373 (0.00%)	0	1/370 (0.27%)	1
Diverticulum oesophageal * 1	0/373 (0.00%)	0	0/370 (0.00%)	0	0/215 (0.00%)	0	1/373 (0.27%)	1	0/370 (0.00%)	0
Abdominal pain * 1	0/373 (0.00%)	0	0/370 (0.00%)	0	0/215 (0.00%)	0	0/373 (0.00%)	0	1/370 (0.27%)	1
Pancreatic fistula * 1	0/373 (0.00%)	0	0/370 (0.00%)	0	0/215 (0.00%)	0	0/373 (0.00%)	0	1/370 (0.27%)	1
General disorders
Non-cardiac chest pain * 1	0/373 (0.00%)	0	0/370 (0.00%)	0	1/215 (0.47%)	1	0/373 (0.00%)	0	1/370 (0.27%)	1
Hepatobiliary disorders
Bile duct stone * 1	0/373 (0.00%)	0	0/370 (0.00%)	0	0/215 (0.00%)	0	0/373 (0.00%)	0	1/370 (0.27%)	1
Infections and infestations
Dengue fever * 1	1/373 (0.27%)	1	0/370 (0.00%)	0	0/215 (0.00%)	0	1/373 (0.27%)	1	0/370 (0.00%)	0
Atypical pneumonia * 1	0/373 (0.00%)	0	1/370 (0.27%)	1	0/215 (0.00%)	0	0/373 (0.00%)	0	1/370 (0.27%)	1
Appendicitis * 1	0/373 (0.00%)	0	0/370 (0.00%)	0	2/215 (0.93%)	2	0/373 (0.00%)	0	0/370 (0.00%)	0
Gastroenteritis * 1	0/373 (0.00%)	0	0/370 (0.00%)	0	0/215 (0.00%)	0	0/373 (0.00%)	0	1/370 (0.27%)	1
Peritoneal abscess * 1	0/373 (0.00%)	0	0/370 (0.00%)	0	0/215 (0.00%)	0	0/373 (0.00%)	0	1/370 (0.27%)	1
Extradural abscess * 1	0/373 (0.00%)	0	0/370 (0.00%)	0	1/215 (0.47%)	1	0/373 (0.00%)	0	0/370 (0.00%)	0
Tooth abscess * 1	0/373 (0.00%)	0	0/370 (0.00%)	0	1/215 (0.47%)	1	0/373 (0.00%)	0	1/370 (0.27%)	1
Localised infection * 1	0/373 (0.00%)	0	0/370 (0.00%)	0	1/215 (0.47%)	1	0/373 (0.00%)	0	0/370 (0.00%)	0
Respiratory tract infection * 1	0/373 (0.00%)	0	0/370 (0.00%)	0	0/215 (0.00%)	0	0/373 (0.00%)	0	1/370 (0.27%)	1
Pneumonia * 1	0/373 (0.00%)	0	0/370 (0.00%)	0	0/215 (0.00%)	0	0/373 (0.00%)	0	1/370 (0.27%)	1
Soft tissue infection * 1	0/373 (0.00%)	0	0/370 (0.00%)	0	0/215 (0.00%)	0	0/373 (0.00%)	0	1/370 (0.27%)	1
Urosepsis * 1	0/373 (0.00%)	0	0/370 (0.00%)	0	0/215 (0.00%)	0	0/373 (0.00%)	0	1/370 (0.27%)	2
Latent tuberculosis * 1	0/373 (0.00%)	0	0/370 (0.00%)	0	1/215 (0.47%)	1	0/373 (0.00%)	0	0/370 (0.00%)	0
Pyelonephritis * 1	0/373 (0.00%)	0	0/370 (0.00%)	0	0/215 (0.00%)	0	1/373 (0.27%)	1	0/370 (0.00%)	0
Injury, poisoning and procedural complications
Road traffic accident * 1	1/373 (0.27%)	1	0/370 (0.00%)	0	1/215 (0.47%)	1	1/373 (0.27%)	1	0/370 (0.00%)	0
Laceration * 1	1/373 (0.27%)	1	0/370 (0.00%)	0	0/215 (0.00%)	0	1/373 (0.27%)	1	0/370 (0.00%)	0
Cervical vertebral fracture * 1	1/373 (0.27%)	1	0/370 (0.00%)	0	0/215 (0.00%)	0	1/373 (0.27%)	1	0/370 (0.00%)	0
Thoracic vertebral fracture * 1	1/373 (0.27%)	1	0/370 (0.00%)	0	0/215 (0.00%)	0	1/373 (0.27%)	1	0/370 (0.00%)	0
Musculoskeletal and connective tissue disorders
Arthralgia * 1	0/373 (0.00%)	0	1/370 (0.27%)	1	0/215 (0.00%)	0	0/373 (0.00%)	0	1/370 (0.27%)	1
Osteoarthritis * 1	0/373 (0.00%)	0	1/370 (0.27%)	1	0/215 (0.00%)	0	0/373 (0.00%)	0	1/370 (0.27%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ * 1	1/373 (0.27%)	1	0/370 (0.00%)	0	0/215 (0.00%)	0	1/373 (0.27%)	1	0/370 (0.00%)	0
Basal cell carcinoma * 1	0/373 (0.00%)	0	1/370 (0.27%)	1	0/215 (0.00%)	0	0/373 (0.00%)	0	1/370 (0.27%)	1
Nervous system disorders
Transient ischaemic attack * 1	0/373 (0.00%)	0	1/370 (0.27%)	1	0/215 (0.00%)	0	0/373 (0.00%)	0	1/370 (0.27%)	1
IIIrd nerve paralysis * 1	0/373 (0.00%)	0	0/370 (0.00%)	0	1/215 (0.47%)	1	0/373 (0.00%)	0	0/370 (0.00%)	0
Pregnancy, puerperium and perinatal conditions
Pregnancy on oral contraceptive * 1	0/373 (0.00%)	0	1/370 (0.27%)	1	0/215 (0.00%)	0	0/373 (0.00%)	0	1/370 (0.27%)	1
Psychiatric disorders
Suicide attempt * 1	1/373 (0.27%)	1	0/370 (0.00%)	0	0/215 (0.00%)	0	1/373 (0.27%)	1	0/370 (0.00%)	0
Renal and urinary disorders
Ureterolithiasis * 1	0/373 (0.00%)	0	0/370 (0.00%)	0	0/215 (0.00%)	0	1/373 (0.27%)	1	0/370 (0.00%)	0
Reproductive system and breast disorders
Uterine polyp * 1	1/373 (0.27%)	1	0/370 (0.00%)	0	0/215 (0.00%)	0	1/373 (0.27%)	1	0/370 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis * 1	0/373 (0.00%)	0	1/370 (0.27%)	1	0/215 (0.00%)	0	0/373 (0.00%)	0	1/370 (0.27%)	1
Asphyxia * 1	0/373 (0.00%)	0	0/370 (0.00%)	0	0/215 (0.00%)	0	0/373 (0.00%)	0	1/370 (0.27%)	1
Pleurisy * 1	0/373 (0.00%)	0	0/370 (0.00%)	0	0/215 (0.00%)	0	1/373 (0.27%)	1	0/370 (0.00%)	0
Aspiration * 1	0/373 (0.00%)	0	0/370 (0.00%)	0	0/215 (0.00%)	0	0/373 (0.00%)	0	1/370 (0.27%)	1
Skin and subcutaneous tissue disorders
Psoriasis * 1	1/373 (0.27%)	1	0/370 (0.00%)	0	0/215 (0.00%)	0	1/373 (0.27%)	1	0/370 (0.00%)	0
Dermal cyst * 1	0/373 (0.00%)	0	0/370 (0.00%)	0	0/215 (0.00%)	0	0/373 (0.00%)	0	1/370 (0.27%)	1
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 (BKZ) 320 mg Q4W (up to Week 16) (SS)		Secukinumab 300 mg Q4W (up to Week 16) (SS)		Bimekizumab (BKZ) 320 mg Q8W (Week 16 to Week 48) (SS)		Bimekizumab (BKZ) 320 mg Q4W (up to Week 48) (SS)		Secukinumab 300 mg Q4W (up to Week 48) (SS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	94/373 (25.20%)		78/370 (21.08%)		83/215 (38.60%)		126/373 (33.78%)		151/370 (40.81%)
Infections and infestations
Nasopharyngitis * 1	47/373 (12.60%)	54	54/370 (14.59%)	61	33/215 (15.35%)	40	62/373 (16.62%)	76	102/370 (27.57%)	140
Oral candidiasis * 1	39/373 (10.46%)	41	4/370 (1.08%)	4	36/215 (16.74%)	47	50/373 (13.40%)	64	11/370 (2.97%)	16
Upper respiratory tract infection * 1	16/373 (4.29%)	16	17/370 (4.59%)	17	21/215 (9.77%)	25	23/373 (6.17%)	26	36/370 (9.73%)	39
Urinary tract infection * 1	6/373 (1.61%)	7	7/370 (1.89%)	8	10/215 (4.65%)	14	15/373 (4.02%)	19	22/370 (5.95%)	30
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gottlieb AB, Warren RB, Augustin M, Garcia L, Cioffi C, Peterson L, Pelligra C, Ciaravino V. Psychometric Validation of the Psoriasis Symptoms and Impacts Measure (P-SIM): A Novel Patient-Reported Outcome Instrument for Patients with Plaque Psoriasis, Using Reported Data from the BE RADIANT Phase 3b Trial. Adv Ther. 2021 Oct;38(10):5253-5269. doi: 10.1007/s12325-021-01836-1. Epub 2021 Sep 2.

Yeremenko N. Out of the shadow of interleukin-17A: the role of interleukin-17F and other interleukin-17 family cytokines in spondyloarthritis. Curr Opin Rheumatol. 2021 Jul 1;33(4):333-340. doi: 10.1097/BOR.0000000000000805.

Reich K, Warren RB, Lebwohl M, Gooderham M, Strober B, Langley RG, Paul C, De Cuyper D, Vanvoorden V, Madden C, Cioffi C, Peterson L, Blauvelt A. Bimekizumab versus Secukinumab in Plaque Psoriasis. N Engl J Med. 2021 Jul 8;385(2):142-152. doi: 10.1056/NEJMoa2102383. Epub 2021 Apr 23.

• Responsible Party: UCB Pharma ( UCB Biopharma SRL )
• ClinicalTrials.gov Identifier: NCT03536884
• Other Study ID Numbers: PS0015; 2017-003784-35 ( EudraCT Number )
• First Submitted: May 14, 2018
• First Posted: May 25, 2018
• Results First Submitted: September 9, 2022
• Results First Posted: October 10, 2022
• Last Update Posted: February 24, 2023