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Clinical Trial Results:
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Summary
EudraCT number	2016-003425-42
Trial protocol	DE GB HU BE FR IT
Global end of trial date	13 Dec 2019

Results information
Results version number	v1
This version publication date	26 Dec 2020
First version publication date	26 Dec 2020
Other versions	v2

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

PS0009

ISRCTN number

US NCT number

NCT03370133

WHO universal trial number (UTN)

Sponsor organisation name

UCB Biopharma SRL

Sponsor organisation address

Allée de la Recherche 60, Brussels, Belgium, 1070

Public contact

Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com

Scientific contact

Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

07 Feb 2020

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

13 Dec 2019

Was the trial ended prematurely?

Main objective of the trial

Compare the efficacy of bimekizumab administered subcutaneously (sc) for 16 weeks versus placebo in the treatment of subjects with moderate to severe plaque psoriasis (PSO)

Protection of trial subjects

During the conduct of the study all participants were closely monitored.

Background therapy

Not Applicable

Evidence for comparator

Ustekinumab has been approved in the US and the EU for the treatment of patients with moderate to severe plaque PSO who are candidates for phototherapy or systemic therapy. Ustekinumab is a human immunoglobulin (Ig) G1κ monoclonal antibody that binds with specificity to the p40 protein subunit used by both the IL-12 and IL-23 cytokines, naturally occurring cytokines that are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation.

Actual start date of recruitment

06 Dec 2017

Long term follow-up planned

Yes

Long term follow-up rationale

Safety

Long term follow-up duration

3 Years

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 14

Country: Number of subjects enrolled

Belgium: 6

Country: Number of subjects enrolled

Canada: 61

Country: Number of subjects enrolled

Germany: 62

Country: Number of subjects enrolled

Hungary: 27

Country: Number of subjects enrolled

Italy: 4

Country: Number of subjects enrolled

Japan: 108

Country: Number of subjects enrolled

Poland: 143

Country: Number of subjects enrolled

Russian Federation: 19

Country: Number of subjects enrolled

United Kingdom: 7

Country: Number of subjects enrolled

United States: 116

Worldwide total number of subjects

567

EEA total number of subjects

249

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

505

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

This study started to enroll participants in December 2017 and concluded in December 2019.

Screening details

The study included a 2-5 week Screening Period, a 16-week Initial Period and a 36-week Maintenance Period. After the Maintenance Period participants either enrolled in an open-label study or had a SFU Visit 20 weeks after their final dose (including those withdrawn from IMP). Participant Flow refers to the Randomized Set and Maintenance Set.

Period 1 title

Initial Treatment Period (WK 16)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Are arms mutually exclusive

Yes

Placebo

Arm description

Participants received placebo up to Week 16 and bimekizumab starting at Week 16 through Week 52.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

PBO

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received placebo at pre-specified time intervals.

Bimekizumab

Arm description

Participants received bimekizumab for 52 weeks.

Arm type

Experimental

Investigational medicinal product name

Bimekizumab

Investigational medicinal product code

BKZ

Other name

UCB4940

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Bimekizumab was provided at pre-specified time intervals.

Ustekinumab

Arm description

Participants received ustekinumab (dose 1 or dose 2 depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding.

Arm type

Active comparator

Investigational medicinal product name

Ustekinumab

Investigational medicinal product code

Uste

Other name

Stelara®

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Ustekinumab was provided as dose 1 for participants weighing <=100 kg and as dose 2 for participants weighing >100 kg at pre-specified time intervals.

Number of subjects in period 1	Placebo	Bimekizumab	Ustekinumab
Started	83	321	163
Completed	74	306	157
Not completed	9	15	6
Adverse event, serious fatal	1	1	1
Consent withdrawn by subject	1	2	1
Adverse event, non-fatal	5	5	2
Non-compliance	-	1	-
Site closed	-	2	-
Lost to follow-up	-	3	-
Lack of efficacy	2	1	-
Protocol deviation	-	-	2

Period 2 title

Maintenance Treatment Period (WK 52)

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Are arms mutually exclusive

Yes

Placebo/Bimekizumab

Arm description

After the 16-week Initial Treatment Period (Initial Period) participants initially randomized to placebo received bimekizumab during the 36-week Maintenance Treatment Period (Maintenance Period).

Arm type

Experimental

Investigational medicinal product name

Bimekizumab

Investigational medicinal product code

BKZ

Other name

UCB4940

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Bimekizumab was provided at pre-specified time intervals.

Bimekizumab/Bimekizumab

Arm description

After the 16-week Initial Treatment Period participants initially randomized to bimekizumab continued to receive bimekizumab during the 36-week Maintenance Treatment Period.

Arm type

Experimental

Investigational medicinal product name

Bimekizumab

Investigational medicinal product code

BKZ

Other name

UCB4940

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Bimekizumab was provided at pre-specified time intervals.

Ustekinumab/Ustekinumab

Arm description

After the 16-week Initial Treatment Period participants initially randomized to ustekinumab continued to receive ustekinumab during the 36-week Maintenance Treatment Period.

Arm type

Active comparator

Investigational medicinal product name

Ustekinumab

Investigational medicinal product code

Uste

Other name

Stelara®

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Ustekinumab was provided as dose 1 for participants weighing <=100 kg and as dose 2 for participants weighing >100 kg at pre-specified time intervals.

Number of subjects in period 2	Placebo/Bimekizumab	Bimekizumab/Bimekizumab	Ustekinumab/Ustekinumab
Started	74	306	157
Completed	69	283	141
Not completed	5	23	16
Consent withdrawn by subject	1	4	4
Adverse event, non-fatal	3	12	4
Non-compliance	-	1	-
Consent Withdrawn for IMP Not Procedures	-	-	1
Lost to follow-up	-	4	3
Protocol deviation	1	1	-
Lack of efficacy	-	1	4

Baseline characteristics

Top of page

Reporting group title

Placebo

Reporting group description

Participants received placebo up to Week 16 and bimekizumab starting at Week 16 through Week 52.

Reporting group title

Bimekizumab

Reporting group description

Participants received bimekizumab for 52 weeks.

Reporting group title

Ustekinumab

Reporting group description

Participants received ustekinumab (dose 1 or dose 2 depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding.

Reporting group values	Placebo	Bimekizumab	Ustekinumab	Total
Number of subjects	83	321	163	567
Age categorical
Units: Subjects
<=18 years	0	2	1	3
Between 18 and 65 years	73	285	144	502
>=65 years	10	34	18	62
Age continuous
Units: years
arithmetic mean (standard deviation)	49.7 ( 13.6 )	45.2 ( 14.0 )	46.0 ( 13.6 )	-
Gender categorical
Units: Subjects
Female	23	92	46	161
Male	60	229	117	406

End points

Top of page

Reporting group title

Placebo

Reporting group description

Participants received placebo up to Week 16 and bimekizumab starting at Week 16 through Week 52.

Reporting group title

Bimekizumab

Reporting group description

Participants received bimekizumab for 52 weeks.

Reporting group title

Ustekinumab

Reporting group description

Participants received ustekinumab (dose 1 or dose 2 depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding.

Reporting group title

Placebo/Bimekizumab

Reporting group description

After the 16-week Initial Treatment Period (Initial Period) participants initially randomized to placebo received bimekizumab during the 36-week Maintenance Treatment Period (Maintenance Period).

Reporting group title

Bimekizumab/Bimekizumab

Reporting group description

After the 16-week Initial Treatment Period participants initially randomized to bimekizumab continued to receive bimekizumab during the 36-week Maintenance Treatment Period.

Reporting group title

Ustekinumab/Ustekinumab

Reporting group description

After the 16-week Initial Treatment Period participants initially randomized to ustekinumab continued to receive ustekinumab during the 36-week Maintenance Treatment Period.

Subject analysis set title

Placebo (RS)

Subject analysis set type

Full analysis

Subject analysis set description

Participants received placebo up to Week 16 and bimekizumab starting at Week 16 through Week 52. Participants formed the Randomized Set (RS).

Subject analysis set title

Bimekizumab (RS)

Subject analysis set type

Full analysis

Subject analysis set description

Participants received bimekizumab for 52 weeks. Participants formed the RS.

Subject analysis set title

Ustekinumab (RS)

Subject analysis set type

Full analysis

Subject analysis set description

Participants received ustekinumab(dose 1 or dose 2 depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the RS.

Subject analysis set title

Placebo Initial Period (SS)

Subject analysis set type

Safety analysis

Subject analysis set description

During the 16-week Initial Treatment Period participants received placebo. Participants formed the Safety Set (SS).

Subject analysis set title

Bimekizumab Initial Period (SS)

Subject analysis set type

Safety analysis

Subject analysis set description

During the 16-week Initial Treatment Period participants received bimekizumab. Participants formed the SS.

Subject analysis set title

Ustekinumab Initial Period (SS)

Subject analysis set type

Safety analysis

Subject analysis set description

During the 16-week Initial Treatment Period participants received ustekinumab. Participants formed the SS.

Subject analysis set title

Any Bimekizumab (AMS)

Subject analysis set type

Safety analysis

Subject analysis set description

This arm consisted of all participants who received bimekizumab at any time in the study (up to Week 52). It also includes the participants that switched from placebo to bimekizumab after the 16-week Initial Treatment Period. Participants formed the SS.

Subject analysis set title

Any Ustekinumab (AMS)

Subject analysis set type

Safety analysis

Subject analysis set description

This arm consisted of all participants who received ustekinumab at any time in the study (up to Week 52). Participants formed the SS.

Subject analysis set title

Placebo (SS)

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received placebo up to Week 16 and bimekizumab starting at Week 16 through Week 52. Participants formed the Safety Set (SS).

Subject analysis set title

Bimekizumab (SS)

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received bimekizumab for 52 weeks. Participants formed the SS.

Subject analysis set title

Ustekinumab (SS)

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received ustekinumab (dose 1 or dose 2 depending on participants weight) for 52 weeks. Placebo was administered at pre-specified time points to maintain the blinding. Participants formed the SS.

Subject analysis set title

Placebo/Bimekizumab (MS)

Subject analysis set type

Safety analysis

Subject analysis set description

After the 16-week Initial Treatment Period participants initially randomized to placebo received bimekizumab during the 36-week Maintenance Treatment Period. Participants formed the Maintenance Set (MS).

Subject analysis set title

Bimekizumab/Bimekizumab (MS)

Subject analysis set type

Safety analysis

Subject analysis set description

After the 16-week Initial Treatment Period participants initially randomized to bimekizumab continued to receive bimekizumab during the 36-week Maintenance Treatment Period. Participants formed the MS.

Subject analysis set title

Ustekinumab/Ustekinumab (MS)

Subject analysis set type

Safety analysis

Subject analysis set description

After the 16-week Initial Treatment Period participants initially randomized to ustekinumab continued to receive ustekinumab during the 36-week Maintenance Treatment Period. Participants formed the MS.

Primary: Percentage of participants with a Psoriasis Area and Severity Index 90 (PASI90) response at Week 16

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End point title

Percentage of participants with a Psoriasis Area and Severity Index 90 (PASI90) response at Week 16

End point 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 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head/arms/trunk to groin/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)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 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 min possible PASI score is 0=no disease, the max score is 72=maximal disease. The RS consisted of all randomized study participants.

End point type

Primary

End point timeframe

Week 16

End point values	Placebo (RS)	Bimekizumab (RS)	Ustekinumab (RS)
Number of subjects analysed	83	321	163
Units: percentage of participants
number (not applicable)	4.8	85.0	49.7

Statistical analysis 1

Statistical analysis description

Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.

Comparison groups

Bimekizumab (RS) v Placebo (RS)

Number of subjects included in analysis

404

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[1]

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

99.869

Confidence interval

level

95%

sides

2-sided

lower limit

34.02

upper limit

293.175

Notes
[1] - P-values for the comparison of treatment groups (BKZ vs PBO) were based on the CMH test from the general association.

Statistical analysis 2

Statistical analysis description

Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.

Comparison groups

Bimekizumab (RS) v Ustekinumab (RS)

Number of subjects included in analysis

484

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[2]

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

6.056

Confidence interval

level

95%

sides

2-sided

lower limit

3.874

upper limit

9.466

Notes
[2] - P-values for the comparison of treatment groups (BKZ vs Ustekinumab) were based on the CMH test from the general association.

Primary: Percentage of participants with an Investigator's Global Assessment (IGA) (Clear or Almost Clear with at least a 2-category improvement from Baseline) response at Week 16

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End point title

Percentage of participants with an Investigator's Global Assessment (IGA) (Clear or Almost Clear with at least a 2-category improvement from Baseline) response at Week 16

End point 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. IGA response was defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline at Week 16. The Randomized Set (RS) consisted of all randomized study participants.

End point type

Primary

End point timeframe

Week 16

End point values	Placebo (RS)	Bimekizumab (RS)	Ustekinumab (RS)
Number of subjects analysed	83	321	163
Units: percentage of participants
number (not applicable)	4.8	84.1	53.4

Statistical analysis 1

Statistical analysis description

Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.

Comparison groups

Bimekizumab (RS) v Placebo (RS)

Number of subjects included in analysis

404

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[3]

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

118.762

Confidence interval

level

95%

sides

2-sided

lower limit

36.701

upper limit

384.307

Notes
[3] - P-values for the comparison of treatment groups (BKZ vs PBO) were based on the CMH test from the general association.

Statistical analysis 2

Statistical analysis description

Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.

Comparison groups

Bimekizumab (RS) v Ustekinumab (RS)

Number of subjects included in analysis

484

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[4]

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

4.809

Confidence interval

level

95%

sides

2-sided

lower limit

3.096

upper limit

7.47

Notes
[4] - P-values for the comparison of treatment groups (BKZ vs Ustekinumab) were based on the CMH test from the general association.

Secondary: Percentage of participants with a PASI100 response at Week 16

Top of page

End point title

Percentage of participants with a PASI100 response at Week 16

End point description

The PASI100 response assessments are based on a 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/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)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 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 min possible PASI score is 0=no disease, the max score is 72=maximal disease. The RS consisted of all randomized study participants.

End point type

Secondary

End point timeframe

Week 16

End point values	Placebo (RS)	Bimekizumab (RS)	Ustekinumab (RS)
Number of subjects analysed	83	321	163
Units: percentage of participants
number (not applicable)	0	58.6	20.9

Statistical analysis 1

Statistical analysis description

Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.

Comparison groups

Bimekizumab (RS) v Placebo (RS)

Number of subjects included in analysis

404

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[5]

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

25.59

Confidence interval

level

95%

sides

2-sided

lower limit

9.063

upper limit

72.253

Notes
[5] - P-values for the comparison of treatment groups (BKZ vs PBO) were based on the CMH test from the general association.

Secondary: Percentage of participants with an IGA 0 response at Week 16

Top of page

End point title

Percentage of participants with an IGA 0 response at Week 16

End point 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. IGA response was defined as clear [0] with at least a two-category improvement from Baseline at Week 16. The Randomized Set (RS) consisted of all randomized study participants.

End point type

Secondary

End point timeframe

Week 16

End point values	Placebo (RS)	Bimekizumab (RS)	Ustekinumab (RS)
Number of subjects analysed	83	321	163
Units: percentage of participants
number (not applicable)	0	58.6	22.1

Statistical analysis 1

Statistical analysis description

Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.

Comparison groups

Bimekizumab (RS) v Placebo (RS)

Number of subjects included in analysis

404

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[6]

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

25.471

Confidence interval

level

95%

sides

2-sided

lower limit

9.02

upper limit

71.925

Notes
[6] - P-values for the comparison of treatment groups (BKZ vs PBO) were based on the CMH test from the general association.

Secondary: Percentage of participants with a PASI75 response at Week 4

Top of page

End point title

Percentage of participants with a PASI75 response at Week 4

End point 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/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)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 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 min possible PASI score is 0=no disease, the max score is 72=maximal disease. The RS consisted of all randomized study participants.

End point type

Secondary

End point timeframe

Week 4

End point values	Placebo (RS)	Bimekizumab (RS)	Ustekinumab (RS)
Number of subjects analysed	83	321	163
Units: percentage of participants
number (not applicable)	2.4	76.9	15.3

Statistical analysis 1

Statistical analysis description

Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.

Comparison groups

Bimekizumab (RS) v Placebo (RS)

Number of subjects included in analysis

404

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[7]

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

123.02

Confidence interval

level

95%

sides

2-sided

lower limit

29.394

upper limit

514.862

Notes
[7] - P-values for the comparison of treatment groups (BKZ vs PBO) were based on the CMH test from the general association.

Statistical analysis 2

Statistical analysis description

Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.

Comparison groups

Bimekizumab (RS) v Ustekinumab (RS)

Number of subjects included in analysis

484

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[8]

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

18.202

Confidence interval

level

95%

sides

2-sided

lower limit

10.998

upper limit

30.123

Notes
[8] - P-values for the comparison of treatment groups (BKZ vs Ustekinumab) were based on the CMH test from the general association.

Secondary: Percentage of participants with a Patient Symptom Diary response for pain at Week 16

Top of page

End point title

Percentage of participants with a Patient Symptom Diary response for pain at Week 16

End point description

A PRO measured the PSD (further published as P-SIM) and was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained the participants on the use of the electronic device used to collect ePRO diary data at the Screening Visit, following which the device was dispensed to the participant for home use until the Week 16 Visit. The ePRO diary was completed on a daily basis from Screening to the Week 16 Visit. PSD score for pain was an average of the daily values over the week prior to the visit. The response variable was characterized in terms of cumulative percent of participants demonstrating a prespecified point improvement (above the 1.98 response threshold) at Week 16. Analysis was limited to participants with a Baseline score at or above the 1.98 response threshold. The RS consisted of all randomized participants. Number of participants analyzed reflect those with a Baseline score at or above the 1.98 response threshold.

End point type

Secondary

End point timeframe

Week 16

End point values	Placebo (RS)	Bimekizumab (RS)	Ustekinumab (RS)
Number of subjects analysed	54	229	107
Units: percentage of participants
number (not applicable)	16.7	77.3	68.2

Statistical analysis 1

Statistical analysis description

Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.

Comparison groups

Bimekizumab (RS) v Placebo (RS)

Number of subjects included in analysis

283

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[9]

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

16.258

Confidence interval

level

95%

sides

2-sided

lower limit

7.356

upper limit

35.931

Notes
[9] - P-values for the comparison of treatment groups (BKZ vs PBO) were based on the CMH test from the general association.

Secondary: Percentage of participants with a Patient Symptom Diary response for itch at Week 16

Top of page

End point title

Percentage of participants with a Patient Symptom Diary response for itch at Week 16

End point description

A PRO measured the PSD (further published as P-SIM) and was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained the participants on the use of the electronic device used to collect ePRO diary data at the Screening Visit, following which the device was dispensed to the participant for home use until the Week 16 Visit. The ePRO diary was completed on a daily basis from Screening to the Week 16 Visit. PSD score for itch was an average of the daily values over the week prior to the visit. The response variable was characterized in terms of cumulative percent of participants demonstrating a prespecified point improvement (above the 2.39 response threshold) at Week 16. Analysis was limited to participants with a Baseline score at or above the 2.39 response threshold. The RS consisted of all randomized participants. Number of participants analyzed reflect those with a Baseline score at or above the 2.39 response threshold.

End point type

Secondary

End point timeframe

Week 16

End point values	Placebo (RS)	Bimekizumab (RS)	Ustekinumab (RS)
Number of subjects analysed	61	244	117
Units: percentage of participants
number (not applicable)	13.1	76.6	65.8

Statistical analysis 1

Statistical analysis description

Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.

Comparison groups

Bimekizumab (RS) v Placebo (RS)

Number of subjects included in analysis

305

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[10]

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

22.279

Confidence interval

level

95%

sides

2-sided

lower limit

9.795

upper limit

50.674

Notes
[10] - P-values for the comparison of treatment groups (BKZ vs PBO) were based on the CMH test from the general association.

Secondary: Percentage of participants with a Patient Symptom Diary response for scaling at Week 16

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End point title

Percentage of participants with a Patient Symptom Diary response for scaling at Week 16

End point description

A PRO measured the PSD (further published as P-SIM) and was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained the participants on the use of the electronic device used to collect ePRO diary data at the Screening Visit, following which the device was dispensed to the participant for home use until the Week 16 Visit. The ePRO diary was completed on a daily basis from Screening to the Week 16 Visit. PSD score for scaling was an average of the daily values over the week prior to the visit. The response variable was characterized in terms of cumulative percent of participants demonstrating a prespecified point improvement (above the 2.86 response threshold) at Week 16. Analysis was limited to participants with a Baseline score at or above the 2.86 response threshold. The RS consisted of all randomized participants. Number of participants analyzed reflect those with a Baseline score at or above the 2.86 response threshold.

End point type

Secondary

End point timeframe

Week 16

End point values	Placebo (RS)	Bimekizumab (RS)	Ustekinumab (RS)
Number of subjects analysed	63	246	116
Units: percentage of participants
number (not applicable)	12.7	78.5	59.5

Statistical analysis 1

Statistical analysis description

Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.

Comparison groups

Bimekizumab (RS) v Placebo (RS)

Number of subjects included in analysis

309

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[11]

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

23.049

Confidence interval

level

95%

sides

2-sided

lower limit

10.201

upper limit

52.077

Notes
[11] - P-values for the comparison of treatment groups (BKZ vs PBO) were based on the CMH test from the general association.

Secondary: Percentage of participants with a Scalp IGA response (Clear or Almost Clear) at Week 16 for participants with scalp psoriasis (PSO) >=2 at Baseline

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End point title

Percentage of participants with a Scalp IGA response (Clear or Almost Clear) at Week 16 for participants with scalp psoriasis (PSO) >=2 at Baseline

End point description

Only participants with scalp involvement at Baseline completed the scalp IGA. Participants with scalp involvement at Baseline were defined as those with a scalp IGA score >0 at Baseline. Scalp lesions were assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe). Scalp IGA 0/1 response at Week 16 was defined as clear (0) or almost clear (1) with at least a 2-category improvement from Baseline to Week 16. The Randomized Set (RS) consisted of all randomized study participants. Number of participants analyzed reflect those with a Baseline score of at least 2.

End point type

Secondary

End point timeframe

Week 16

End point values	Placebo (RS)	Bimekizumab (RS)	Ustekinumab (RS)
Number of subjects analysed	72	285	146
Units: percentage of participants
number (not applicable)	15.3	84.2	70.5

Statistical analysis 1

Statistical analysis description

Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.

Comparison groups

Bimekizumab (RS) v Placebo (RS)

Number of subjects included in analysis

357

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[12]

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

37.696

Confidence interval

level

95%

sides

2-sided

lower limit

16.92

upper limit

83.987

Notes
[12] - P-values for the comparison of treatment groups (BKZ vs PBO) were based on the CMH test from the general association.

Secondary: Percentage of participants with a PASI90 response at Week 12

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End point title

Percentage of participants with a PASI90 response at Week 12

End point 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/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)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 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 min possible PASI score is 0=no disease, the max score is 72=maximal disease. The RS consisted of all randomized study participants.

End point type

Secondary

End point timeframe

Week 12

End point values	Placebo (RS)	Bimekizumab (RS)	Ustekinumab (RS)
Number of subjects analysed	83	321	163
Units: percentage of participants
number (not applicable)	2.4	85.0	43.6

Statistical analysis 1

Statistical analysis description

Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.

Comparison groups

Bimekizumab (RS) v Ustekinumab (RS)

Number of subjects included in analysis

484

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[13]

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

8.047

Confidence interval

level

95%

sides

2-sided

lower limit

5.107

upper limit

12.679

Notes
[13] - P-values for the comparison of treatment groups (BKZ vs Ustekinumab) were based on the CMH test from the general association.

Secondary: Percentage of participants with a PASI90 response at Week 52

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End point title

Percentage of participants with a PASI90 response at Week 52

End point description

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/scaliness of the psoriatic lesions (0-4 scale) and weights the resulting score by the area of skin involved. Body divided into 4 areas: head/arms/trunk to groin/legs to top of buttocks. Assignment of an average score for the redness/thickness/scaling for each of the 4 body areas with a score of 0 (clear)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 scale. Final PASI=average redness/thickness/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. Min possible PASI score is 0=no disease, the max score is 72=maximal disease. The RS consisted of all randomized participants. PBO was provided up to Week 16 and not included in the analysis.

End point type

Secondary

End point timeframe

Week 52

End point values	Bimekizumab (RS)	Ustekinumab (RS)
Number of subjects analysed	321	163
Units: percentage of participants
number (not applicable)	81.9	55.8

Statistical analysis 1

Statistical analysis description

Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.

Comparison groups

Bimekizumab (RS) v Ustekinumab (RS)

Number of subjects included in analysis

484

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[14]

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

3.795

Confidence interval

level

95%

sides

2-sided

lower limit

2.442

upper limit

5.899

Notes
[14] - P-values for the comparison of treatment groups (BKZ vs Ustekinumab) were based on the CMH test from the general association.

Secondary: Percentage of participants with an IGA (Clear or Almost Clear with at least a 2-category improvement from Baseline) response at Week 12

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End point title

Percentage of participants with an IGA (Clear or Almost Clear with at least a 2-category improvement from Baseline) response at Week 12

End point 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. IGA response was defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline at Week 12. The Randomized Set (RS) consisted of all randomized study participants.

End point type

Secondary

End point timeframe

Week 12

End point values	Placebo (RS)	Bimekizumab (RS)	Ustekinumab (RS)
Number of subjects analysed	83	321	163
Units: percentage of participants
number (not applicable)	4.8	81.9	52.1

Statistical analysis 1

Statistical analysis description

Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.

Comparison groups

Bimekizumab (RS) v Ustekinumab (RS)

Number of subjects included in analysis

484

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[15]

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

4.379

Confidence interval

level

95%

sides

2-sided

lower limit

2.85

upper limit

6.73

Notes
[15] - P-values for the comparison of treatment groups (BKZ vs Ustekinumab) were based on the CMH test from the general association.

Secondary: Percentage of participants with an IGA (Clear or Almost Clear with at least a 2-category improvement from Baseline) response at Week 52

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End point title

Percentage of participants with an IGA (Clear or Almost Clear with at least a 2-category improvement from Baseline) response at Week 52

End point 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. IGA response was defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline at Week 52. The Randomized Set (RS) consisted of all randomized study participants. Placebo was only provided up to Week 16 and was not included in this analysis.

End point type

Secondary

End point timeframe

Week 52

End point values	Bimekizumab (RS)	Ustekinumab (RS)
Number of subjects analysed	321	163
Units: percentage of participants
number (not applicable)	78.2	60.7

Statistical analysis 1

Statistical analysis description

Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.

Comparison groups

Bimekizumab (RS) v Ustekinumab (RS)

Number of subjects included in analysis

484

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[16]

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

2.412

Confidence interval

level

95%

sides

2-sided

lower limit

1.573

upper limit

3.699

Notes
[16] - P-values for the comparison of treatment groups (BKZ vs Ustekinumab) were based on the CMH test from the general association.

Secondary: Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment during the Initial Treatment Period

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End point title

Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment during the Initial Treatment Period

End point 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 Adverse Event (AE) being considered. If a participant had no events, the total time at risk was used. The Safety Set (SS) consisted of all study participants that received at least 1 dose of IMP.

End point type

Secondary

End point timeframe

From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)

End point values	Placebo (SS)	Bimekizumab (SS)	Ustekinumab (SS)
Number of subjects analysed	83	321	163
Units: no. of new events per 100 subject-years
number (confidence interval 95%)	238.41 (169.53 to 325.91)	287.26 (246.93 to 332.29)	247.62 (197.23 to 306.96)

No statistical analyses for this end point

Secondary: Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment during the Initial Treatment Period

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End point title

Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment during the Initial Treatment Period

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

End point type

Secondary

End point timeframe

From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)

End point values	Placebo (SS)	Bimekizumab (SS)	Ustekinumab (SS)
Number of subjects analysed	83	321	163
Units: no. of new events per 100 subject-years
number (confidence interval 95%)	7.97 (0.97 to 28.80)	5.06 (1.64 to 11.80)	10.14 (3.29 to 23.66)

No statistical analyses for this end point

Secondary: Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment during the Initial Treatment Period

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End point title

Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment during the Initial Treatment Period

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

End point type

Secondary

End point timeframe

From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)

End point values	Placebo (SS)	Bimekizumab (SS)	Ustekinumab (SS)
Number of subjects analysed	83	321	163
Units: no. of new events per 100 subject-years
number (confidence interval 95%)	24.39 (8.95 to 53.09)	6.08 (2.23 to 13.24)	5.99 (1.24 to 17.52)

No statistical analyses for this end point

Secondary: Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment during the Maintenance Treatment Period

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End point title

Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment during the Maintenance Treatment Period

End point description

The number of TEAEs 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 Adverse Event (AE) being considered. If a participant had no events, the total time at risk was used. The Maintenance Set (MS) consisted of all study participants who had received at least 1 dose of active IMP (bimekizumab or ustekinumab) in the Maintenance Treatment Period.

End point type

Secondary

End point timeframe

From Week 16 to Safety Follow-Up (up to 52 weeks duration)

End point values	Placebo/Bimekizumab (MS)	Bimekizumab/Bimekizumab (MS)	Ustekinumab/Ustekinumab (MS)
Number of subjects analysed	74	306	157
Units: no. of new events per 100 subject-years
number (confidence interval 95%)	149.35 (114.24 to 191.85)	127.84 (111.58 to 145.81)	111.24 (90.80 to 134.91)

No statistical analyses for this end point

Secondary: Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment during the Maintenance Treatment Period

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End point title

Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment during the Maintenance Treatment Period

End point 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. The Maintenance Set (MS) consisted of all study participants who had received at least 1 dose of active IMP (bimekizumab or ustekinumab) in the Maintenance Treatment Period.

End point type

Secondary

End point timeframe

From Week 16 to Safety Follow-Up (up to 52 weeks duration)

End point values	Placebo/Bimekizumab (MS)	Bimekizumab/Bimekizumab (MS)	Ustekinumab/Ustekinumab (MS)
Number of subjects analysed	74	306	157
Units: no. of new events per 100 subject-years
number (confidence interval 95%)	9.88 (3.21 to 23.05)	6.19 (3.30 to 10.58)	7.46 (3.22 to 14.70)

No statistical analyses for this end point

Secondary: Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment during the Maintenance Treatment Period

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End point title

Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment during the Maintenance Treatment Period

End point 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. The Maintenance Set (MS) consisted of all study participants who had received at least 1 dose of active IMP (bimekizumab or ustekinumab) in the Maintenance Treatment Period.

End point type

Secondary

End point timeframe

From Week 16 to Safety Follow-Up (up to 52 weeks duration)

End point values	Placebo/Bimekizumab (MS)	Bimekizumab/Bimekizumab (MS)	Ustekinumab/Ustekinumab (MS)
Number of subjects analysed	74	306	157
Units: no. of new events per 100 subject-years
number (confidence interval 95%)	5.91 (1.22 to 17.27)	5.72 (2.95 to 9.99)	3.71 (1.01 to 9.51)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)

Adverse event reporting additional description

Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up [SFU] Period). Deaths in Any bimekizumab arm occurred in the initial period (1 in Placebo/ 1 in bimekizumab).

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

19.0

Reporting group title

Placebo Initial Period (SS)

Reporting group description

During the 16-week Initial Treatment Period participants received placebo. Participants formed the Safety Set (SS).

Reporting group title

Bimekizumab Initial Period (SS)

Reporting group description

During the 16-week Initial Treatment Period participants received bimekizumab. Participants formed the SS.

Reporting group title

Ustekinumab Initial Period (SS)

Reporting group description

During the 16-week Initial Treatment Period participants received ustekinumab. Participants formed the SS.

Reporting group title

Any Bimekizumab (AMS)

Reporting group description

Reporting group title

Any Ustekinumab (AMS)

Reporting group description

This arm consisted of all participants who received ustekinumab at any time in the study (up to Week 52). Participants formed the SS.

Serious adverse events	Placebo Initial Period (SS)	Bimekizumab Initial Period (SS)	Ustekinumab Initial Period (SS)	Any Bimekizumab (AMS)	Any Ustekinumab (AMS)
Total subjects affected by serious adverse events
subjects affected / exposed	2 / 83 (2.41%)	5 / 321 (1.56%)	5 / 163 (3.07%)	24 / 395 (6.08%)	13 / 163 (7.98%)
number of deaths (all causes)	1	1	1	2	1
number of deaths resulting from adverse events	0	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
subjects affected / exposed	1 / 83 (1.20%)	0 / 321 (0.00%)	0 / 163 (0.00%)	0 / 395 (0.00%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
Gastric cancer
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	1 / 395 (0.25%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Thyroid adenoma
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	0 / 395 (0.00%)	1 / 163 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Surgical and medical procedures
Metabolic surgery
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	1 / 395 (0.25%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Haemorrhage in pregnancy
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	1 / 395 (0.25%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Death
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	1 / 395 (0.25%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
Respiratory, thoracic and mediastinal disorders
Epistaxis
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	1 / 395 (0.25%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Alcoholism
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	1 / 395 (0.25%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Suicide attempt
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	0 / 395 (0.00%)	1 / 163 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
Liver function test increased
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	1 / 395 (0.25%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
False positive tuberculosis test
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	1 / 395 (0.25%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Heart injury
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	1 / 163 (0.61%)	0 / 395 (0.00%)	1 / 163 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
Tendon injury
subjects affected / exposed	1 / 83 (1.20%)	0 / 321 (0.00%)	0 / 163 (0.00%)	0 / 395 (0.00%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Toxicity to various agents
subjects affected / exposed	1 / 83 (1.20%)	0 / 321 (0.00%)	0 / 163 (0.00%)	0 / 395 (0.00%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	1 / 395 (0.25%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tibia fracture
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	0 / 395 (0.00%)	1 / 163 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Upper limb fracture
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	1 / 395 (0.25%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Acute myocardial infarction
subjects affected / exposed	0 / 83 (0.00%)	1 / 321 (0.31%)	0 / 163 (0.00%)	2 / 395 (0.51%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac arrest
subjects affected / exposed	0 / 83 (0.00%)	1 / 321 (0.31%)	1 / 163 (0.61%)	1 / 395 (0.25%)	1 / 163 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 1	0 / 1
Myocardial infarction
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	2 / 395 (0.51%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Intracranial aneurysm
subjects affected / exposed	0 / 83 (0.00%)	1 / 321 (0.31%)	0 / 163 (0.00%)	1 / 395 (0.25%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Brain injury
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	1 / 163 (0.61%)	0 / 395 (0.00%)	1 / 163 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
Cerebral infarction
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	1 / 395 (0.25%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hydrocephalus
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	0 / 395 (0.00%)	1 / 163 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vocal cord paresis
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	1 / 395 (0.25%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Eye disorders
Macular hole
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	1 / 163 (0.61%)	0 / 395 (0.00%)	1 / 163 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Haemorrhoids
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	0 / 395 (0.00%)	1 / 163 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Colitis ulcerative
subjects affected / exposed	0 / 83 (0.00%)	1 / 321 (0.31%)	0 / 163 (0.00%)	1 / 395 (0.25%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Psoriasis
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	1 / 395 (0.25%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Osteochondrosis
subjects affected / exposed	0 / 83 (0.00%)	1 / 321 (0.31%)	0 / 163 (0.00%)	1 / 395 (0.25%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intervertebral disc protrusion
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	1 / 163 (0.61%)	0 / 395 (0.00%)	1 / 163 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Facet joint syndrome
subjects affected / exposed	0 / 83 (0.00%)	1 / 321 (0.31%)	0 / 163 (0.00%)	1 / 395 (0.25%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Arthritis
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	0 / 395 (0.00%)	1 / 163 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Spinal column stenosis
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	1 / 395 (0.25%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Wound infection
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	1 / 163 (0.61%)	0 / 395 (0.00%)	1 / 163 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	1 / 163 (0.61%)	0 / 395 (0.00%)	1 / 163 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	1 / 395 (0.25%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Oesophageal candidiasis
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	1 / 395 (0.25%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Mastoiditis
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	0 / 395 (0.00%)	1 / 163 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Otitis externa
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	0 / 395 (0.00%)	1 / 163 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Otitis media acute
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	0 / 395 (0.00%)	1 / 163 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	0 / 395 (0.00%)	1 / 163 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infective tenosynovitis
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	1 / 395 (0.25%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Necrotising fasciitis
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	1 / 395 (0.25%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Subglottic laryngitis
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	1 / 395 (0.25%)	0 / 163 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Diabetes mellitus
subjects affected / exposed	0 / 83 (0.00%)	0 / 321 (0.00%)	0 / 163 (0.00%)	0 / 395 (0.00%)	1 / 163 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Placebo Initial Period (SS)	Bimekizumab Initial Period (SS)	Ustekinumab Initial Period (SS)	Any Bimekizumab (AMS)	Any Ustekinumab (AMS)
Total subjects affected by non serious adverse events
subjects affected / exposed	17 / 83 (20.48%)	87 / 321 (27.10%)	37 / 163 (22.70%)	192 / 395 (48.61%)	73 / 163 (44.79%)
Vascular disorders
Hypertension
subjects affected / exposed	1 / 83 (1.20%)	7 / 321 (2.18%)	5 / 163 (3.07%)	14 / 395 (3.54%)	10 / 163 (6.13%)
occurrences all number	1	7	5	14	11
Nervous system disorders
Headache
subjects affected / exposed	0 / 83 (0.00%)	11 / 321 (3.43%)	7 / 163 (4.29%)	16 / 395 (4.05%)	10 / 163 (6.13%)
occurrences all number	0	11	10	17	14
Skin and subcutaneous tissue disorders
Psoriasis
subjects affected / exposed	5 / 83 (6.02%)	3 / 321 (0.93%)	2 / 163 (1.23%)	9 / 395 (2.28%)	2 / 163 (1.23%)
occurrences all number	5	4	2	11	2
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	2 / 83 (2.41%)	3 / 321 (0.93%)	4 / 163 (2.45%)	10 / 395 (2.53%)	9 / 163 (5.52%)
occurrences all number	2	3	4	10	10
Infections and infestations
Nasopharyngitis
subjects affected / exposed	7 / 83 (8.43%)	30 / 321 (9.35%)	14 / 163 (8.59%)	86 / 395 (21.77%)	36 / 163 (22.09%)
occurrences all number	8	35	15	121	53
Oral candidiasis
subjects affected / exposed	0 / 83 (0.00%)	28 / 321 (8.72%)	0 / 163 (0.00%)	60 / 395 (15.19%)	1 / 163 (0.61%)
occurrences all number	0	30	0	98	1
Upper respiratory tract infection
subjects affected / exposed	2 / 83 (2.41%)	9 / 321 (2.80%)	5 / 163 (3.07%)	36 / 395 (9.11%)	18 / 163 (11.04%)
occurrences all number	2	9	6	48	22
Urinary tract infection
subjects affected / exposed	5 / 83 (6.02%)	6 / 321 (1.87%)	1 / 163 (0.61%)	12 / 395 (3.04%)	6 / 163 (3.68%)
occurrences all number	5	6	1	14	7

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Were there any global substantial amendments to the protocol? Yes

06 Apr 2018

Protocol Amendment 3 (06 Apr 2018) included the following modifications: -Update name and contact information for Sponsor study physician -Extend the duration of the Screening Period, and therefore the overall study duration, by 1 week -Update list of current treatment for psoriasis to reflect changes in labeling and approved countries -Update list of completed and ongoing bimekizumab studies to reflect completion of study UP0042 -Clarify calculation of Psoriasis Area Severity Index responder rates -Remove references to pharmacodynamics assessments as they will not be conducted in this study -Update Schedule of study assessments to include a hematology and biochemistry sample at Week 20, to modify the visits at which the tuberculosis questionnaire, body weight, physical examination, and electrocardiogram are assessed, and to modify the visits at which photographs are taken -Clarify that all visits from first dose to Week 24 would have a ±3 day visit window, while all visits from Week 28 to end of study would have a ±7 day window -Clarify the dosing window -Modify exclusion criterion to clarify exclusion of subjects who have participated in other studies of bimekizumab, other medications (systemic or topical), or devices -Modify exclusion criteria pertaining to history of malignancy, systemic disease, and major depression -Add new withdrawal criteria for nonresponders and for subjects with newly diagnosed inflammatory bowel disease -Clarify withdrawal criteria for subjects with depression or suicidal ideation or behavior

06 Apr 2018

Continuation of Protocol Amendment 3 -Clarify that for subjects receiving ustekinumab, dosing is based on weight at Baseline -Update prohibited concomitant medications to include tildrakizumab and risankizumab -Corrected discrepancies between Section 8 Study procedures by visit and Schedule of study assessments -Revise Psoriatic Arthritis Screening and Evaluation questionnaire scoring -Remove immunophenotyping assessments -Clarify photography requirements -Clarify definition of abortion -Updated laboratory measurements to be performed -Provide additional details for requirements for investigational medicinal product rechallenge in the event of potential drug-induced liver injury -Defined a Maintenance Set as an analysis population -Update the definition of the Full Analysis Set -Clarify regions for analyses -Update the sequence testing In addition, minor spelling, editorial, and formatting changes were made, and the List of abbreviations was updated.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of participants with a Psoriasis Area and Severity Index 90 (PASI90) response at Week 16

Primary: Percentage of participants with a Psoriasis Area and Severity Index 90 (PASI90) response at Week 16

Primary: Percentage of participants with an Investigator's Global Assessment (IGA) (Clear or Almost Clear with at least a 2-category improvement from Baseline) response at Week 16

Primary: Percentage of participants with an Investigator's Global Assessment (IGA) (Clear or Almost Clear with at least a 2-category improvement from Baseline) response at Week 16

Secondary: Percentage of participants with a PASI100 response at Week 16

Secondary: Percentage of participants with a PASI100 response at Week 16

Secondary: Percentage of participants with an IGA 0 response at Week 16

Secondary: Percentage of participants with an IGA 0 response at Week 16

Secondary: Percentage of participants with a PASI75 response at Week 4

Secondary: Percentage of participants with a PASI75 response at Week 4

Secondary: Percentage of participants with a Patient Symptom Diary response for pain at Week 16

Secondary: Percentage of participants with a Patient Symptom Diary response for pain at Week 16

Secondary: Percentage of participants with a Patient Symptom Diary response for itch at Week 16

Secondary: Percentage of participants with a Patient Symptom Diary response for itch at Week 16

Secondary: Percentage of participants with a Patient Symptom Diary response for scaling at Week 16

Secondary: Percentage of participants with a Patient Symptom Diary response for scaling at Week 16

Secondary: Percentage of participants with a Scalp IGA response (Clear or Almost Clear) at Week 16 for participants with scalp psoriasis (PSO) >=2 at Baseline

Secondary: Percentage of participants with a Scalp IGA response (Clear or Almost Clear) at Week 16 for participants with scalp psoriasis (PSO) >=2 at Baseline

Secondary: Percentage of participants with a PASI90 response at Week 12

Secondary: Percentage of participants with a PASI90 response at Week 12

Secondary: Percentage of participants with a PASI90 response at Week 52

Secondary: Percentage of participants with a PASI90 response at Week 52

Secondary: Percentage of participants with an IGA (Clear or Almost Clear with at least a 2-category improvement from Baseline) response at Week 12

Secondary: Percentage of participants with an IGA (Clear or Almost Clear with at least a 2-category improvement from Baseline) response at Week 12

Secondary: Percentage of participants with an IGA (Clear or Almost Clear with at least a 2-category improvement from Baseline) response at Week 52

Secondary: Percentage of participants with an IGA (Clear or Almost Clear with at least a 2-category improvement from Baseline) response at Week 52

Secondary: Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment during the Initial Treatment Period

Secondary: Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment during the Initial Treatment Period

Secondary: Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment during the Initial Treatment Period

Secondary: Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment during the Initial Treatment Period

Secondary: Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment during the Initial Treatment Period

Secondary: Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment during the Initial Treatment Period

Secondary: Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment during the Maintenance Treatment Period

Secondary: Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment during the Maintenance Treatment Period

Secondary: Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment during the Maintenance Treatment Period

Secondary: Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment during the Maintenance Treatment Period

Secondary: Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment during the Maintenance Treatment Period

Secondary: Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment during the Maintenance Treatment Period

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical Trial Results:
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis