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Clinical Trial Results:
A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study with an Initial Treatment Period Followed by a Randomized-Withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects with Moderate to Severe Chronic Plaque Psoriasis

Summary
EudraCT number	2016-003426-16
Trial protocol	GB DE HU
Global end of trial date	07 Jan 2020

Results information
Results version number	v1
This version publication date	09 Jan 2021
First version publication date	09 Jan 2021
Other versions	v2

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

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Trial information

Top of page

Sponsor protocol code

PS0013

ISRCTN number

US NCT number

NCT03410992

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

05 Mar 2020

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

07 Jan 2020

Was the trial ended prematurely?

Main objective of the trial

Compare the efficacy of bimekizumab versus placebo in the treatment of participants 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

Not Applicable

Actual start date of recruitment

05 Feb 2018

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: 10

Country: Number of subjects enrolled

Canada: 89

Country: Number of subjects enrolled

Germany: 38

Country: Number of subjects enrolled

Hungary: 31

Country: Number of subjects enrolled

Poland: 150

Country: Number of subjects enrolled

Russian Federation: 19

Country: Number of subjects enrolled

Korea, Republic of: 7

Country: Number of subjects enrolled

United Kingdom: 6

Country: Number of subjects enrolled

United States: 85

Worldwide total number of subjects

435

EEA total number of subjects

225

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)

410

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

The study started to enroll patients in February 2018 and concluded in January 2020.

Screening details

Study has a 2-5 weeks Screening Period, a 16 weeks Initial Period, a 40 weeks Randomized-Withdrawal Period (RWP) and a SFU Period (20 weeks after final dose). Participants who did not achieve a PASI90 response at Wk16 or who relapsed at Wk20/later during the RWP, entered 12 weeks of escape treatment. Participant Flow refers to the Randomized Set.

Period 1 title

Initial Treatment Period: up to Wk16

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 for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks.

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, administered subcutaneously (sc) at pre-specified time points.

Bimekizumab dose regimen 1

Arm description

Participants received bimekizumab dose regimen 1 for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab dose regimen 1 or bimekizumab dose regimen 2 or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 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.

Number of subjects in period 1	Placebo	Bimekizumab dose regimen 1
Started	86	349
Completed	82	340
Not completed	4	9
Consent withdrawn by subject	1	-
Adverse event, non-fatal	-	5
Lost to follow-up	1	3
Lack of efficacy	2	1

Period 2 title

Week 16 assessment

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

Arm description

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, administered subcutaneously (sc) at pre-specified time points.

Bimekizumab dose regimen 1

Arm description

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.

Number of subjects in period 2	Placebo	Bimekizumab dose regimen 1
Started	82	340
Received escape treatment	81	23 ^[1]
Completed	1	311
Not completed	81	29
PASI90 Non-Response at Week 16	81	23
Incorrect escapers	-	6

Notes
[1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Number of participants at the milestones reflects those who did not achieve a PASI90 response at Week 16 of the Initial Treatment Period and received open-label bimekizumab dose regime 1 for 12 weeks (ie, escape treatment).

Period 3 title

Randomized-Withdrawal Period: up to Wk56

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/Placebo

Arm description

Participants in this arm were randomized to placebo during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive placebo during the Randomized-Withdrawal Period.

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, administered subcutaneously (sc) at pre-specified time points.

Bimekizumab dose regimen 1/Placebo

Arm description

Arm type

Placebo

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.

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, administered subcutaneously (sc) at pre-specified time points.

Bimekizumab dose regimen 1/dose regimen 2

Arm description

Arm type

Experimental

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, administered subcutaneously (sc) at pre-specified time points.

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 dose regimen 1/dose regimen 1

Arm description

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.

Number of subjects in period 3	Placebo/Placebo	Bimekizumab dose regimen 1/Placebo	Bimekizumab dose regimen 1/dose regimen 2	Bimekizumab dose regimen 1/dose regimen 1
Started	1	105	100	106
Received escape treatment	0 ^[2]	67	4 ^[3]	7 ^[4]
Completed	1	33	93	94
Not completed	0	72	7	12
Consent withdrawn by subject	-	-	-	3
Adverse event, non-fatal	-	3	2	-
Lost to follow-up	-	2	1	2
Relapse at Week 20 or later	-	67	4	7

Notes
[2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Number of participants at the milestones reflects those who relapse at Week 20 or later during the Randomized-Withdrawal Period (up to Week 56) and received open-label bimekizumab dose regime 1 for 12 weeks (ie, escape treatment).
[3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Number of participants at the milestones reflects those who relapse at Week 20 or later during the Randomized-Withdrawal Period (up to Week 56) and received open-label bimekizumab dose regime 1 for 12 weeks (ie, escape treatment).
[4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: Number of participants at the milestones reflects those who relapse at Week 20 or later during the Randomized-Withdrawal Period (up to Week 56) and received open-label bimekizumab dose regime 1 for 12 weeks (ie, escape treatment).

Period 4 title

Escape Treatment: 12 Weeks

Is this the baseline period?

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Placebo Escape

Arm description

Participants in this arm were randomized to placebo during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 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.

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, administered subcutaneously (sc) at pre-specified time points.

Bimekizumab dose regimen 1 Escape

Arm description

Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 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.

Bimekizumab dose regimen 1/ Placebo Escape

Arm description

Arm type

Experimental

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, administered subcutaneously (sc) at pre-specified time points.

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 dose regimen 1/dose regimen 2 Escape

Arm description

Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab dose regimen 2 during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks. Participants receiving dose regimen 2 received placebo at pre-specified time points to maintain the blinding.

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.

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, administered subcutaneously (sc) at pre-specified time points.

Bimekizumab dose regimen 1/dose regimen 1 Escape

Arm description

Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab dose regimen 1 during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 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.

Number of subjects in period 4 ^[5]	Placebo Escape	Bimekizumab dose regimen 1 Escape	Bimekizumab dose regimen 1/ Placebo Escape	Bimekizumab dose regimen 1/dose regimen 2 Escape	Bimekizumab dose regimen 1/dose regimen 1 Escape
Started	81	23	67	4	7
Completed	81	22	66	4	7
Not completed	0	1	1	0	0
Consent withdrawn by subject	-	-	1	-	-
Adverse event, non-fatal	-	1	-	-	-

Notes
[5] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: The Escape Treatment is not a subsequent period to the Randomized-Withdrawal period, but rather a separate period. It gives an overview of the participants who did not achieve a PASI90 response at Week 16 of the Initial Treatment Period and all participants who relapsed at Week 20 or later during the Randomized-Withdrawal Period (up to Week 56).

Baseline characteristics

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Reporting group title

Placebo

Reporting group description

Reporting group title

Bimekizumab dose regimen 1

Reporting group description

Reporting group values	Placebo	Bimekizumab dose regimen 1	Total
Number of subjects	86	349	435
Age categorical
Units: Subjects
<=18 years	2	1	3
Between 18 and 65 years	80	327	407
>=65 years	4	21	25
Age continuous
Units: years
arithmetic mean (standard deviation)	43.5 ( 13.1 )	44.5 ( 12.9 )	-
Gender categorical
Units: Subjects
Male	58	255	313
Female	28	94	122

End points

Top of page

Reporting group title

Placebo

Reporting group description

Reporting group title

Bimekizumab dose regimen 1

Reporting group description

Reporting group title

Placebo

Reporting group description

Reporting group title

Bimekizumab dose regimen 1

Reporting group description

Reporting group title

Placebo/Placebo

Reporting group description

Reporting group title

Bimekizumab dose regimen 1/Placebo

Reporting group description

Reporting group title

Bimekizumab dose regimen 1/dose regimen 2

Reporting group description

Reporting group title

Bimekizumab dose regimen 1/dose regimen 1

Reporting group description

Reporting group title

Placebo Escape

Reporting group description

Reporting group title

Bimekizumab dose regimen 1 Escape

Reporting group description

Reporting group title

Bimekizumab dose regimen 1/ Placebo Escape

Reporting group description

Reporting group title

Bimekizumab dose regimen 1/dose regimen 2 Escape

Reporting group description

Reporting group title

Bimekizumab dose regimen 1/dose regimen 1 Escape

Reporting group description

Subject analysis set title

Placebo (RS)

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Bimekizumab dose regimen 1 (RS)

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Placebo (SS)

Subject analysis set type

Safety analysis

Subject analysis set description

Subject analysis set title

Bimekizumab dose regimen 1 (SS)

Subject analysis set type

Safety analysis

Subject analysis set description

Subject analysis set title

Placebo/Placebo (WK16ResS)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Bimekizumab dose regimen 1/Placebo (WK16ResS)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Bimekizumab dose regimen 1/dose regimen 2 (WK16ResS)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab dose regimen 2 during the Randomized-Withdrawal Period. Participants formed the WK16ResS. Participants receiving dose regimen 2 received placebo at pre-specified time points to maintain the blinding.

Subject analysis set title

Bimekizumab dose regimen 1/dose regimen 1 (WK16ResS)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Placebo Escape (ESS)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Bimekizumab dose regimen 1 Escape (ESS)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Bimekizumab dose regimen 1/ Placebo Escape (ESS)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks. Participants formed the ESS.

Subject analysis set title

Bimekizumab dose regimen 1/dose regimen 2 Escape (ESS)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab dose regimen 2 during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks. Participants formed the ESS. Participants receiving dose regimen 2 received placebo at pre-specified time points to maintain the blinding.

Subject analysis set title

Bimekizumab dose regimen 1/dose regimen 1 Escape (ESS)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Bimekizumab dose regimen 1/ 1 + dose regimen 1/ 2 (WK16ResS)

Subject analysis set type

Sub-group analysis

Subject analysis set description

This arm consists of participants who were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab dose regimen 1 during the Randomized-Withdrawal Period and those who were re-randomized to receive bimekizumab dose regimen 2 during the Randomized-Withdrawal Period. Participants formed the WK16ResS. Participants receiving dose regimen 2 received placebo at pre-specified time points to maintain the blinding.

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

A PASI90 responder was defined as a participant that achieved 90% reduction from Baseline in the PASI score. 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. Study participants with missing score at Week 16 were counted as nonresponders (NRI). The Randomized Set (RS) consisted of all randomized study participants.

End point type

Primary

End point timeframe

At Week 16

End point values	Placebo (RS)	Bimekizumab dose regimen 1 (RS)
Number of subjects analysed	86	349
Units: percentage of participants
number (not applicable)	1.2	90.8

Statistical analysis 1

Statistical analysis description

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

Comparison groups

Bimekizumab dose regimen 1 (RS) v Placebo (RS)

Number of subjects included in analysis

435

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[1]

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

496.318

Confidence interval

level

95%

sides

2-sided

lower limit

82.798

upper limit

2975.086

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

Primary: Percentage of participants with an Investigator's Global Assessment (IGA) response at Week 16

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End point title

Percentage of participants with an Investigator's Global Assessment (IGA) 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 or Almost Clear with at least a 2-category improvement relative to Baseline. Study participants with missing score at Week 16 were counted as nonresponders (NRI). The Randomized Set (RS) consisted of all randomized study participants.

End point type

Primary

End point timeframe

At Week 16

End point values	Placebo (RS)	Bimekizumab dose regimen 1 (RS)
Number of subjects analysed	86	349
Units: percentage of participants
number (not applicable)	1.2	92.6

Statistical analysis 1

Statistical analysis description

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

Comparison groups

Bimekizumab dose regimen 1 (RS) v Placebo (RS)

Number of subjects included in analysis

435

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[2]

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

657.255

Confidence interval

level

95%

sides

2-sided

lower limit

105.792

upper limit

4083.333

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

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

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End point title

Percentage of participants with a PASI100 response at Week 16

End point description

A PASI100 responder was defined as a participant that achieved 100% reduction from Baseline in the PASI score. 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. Study participants with missing score at Week 16 were counted as nonresponders (NRI). The Randomized Set (RS) consisted of all randomized study participants.

End point type

Secondary

End point timeframe

At Week 16

End point values	Placebo (RS)	Bimekizumab dose regimen 1 (RS)
Number of subjects analysed	86	349
Units: percentage of participants
number (not applicable)	1.2	68.2

Statistical analysis 1

Statistical analysis description

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

Comparison groups

Bimekizumab dose regimen 1 (RS) v Placebo (RS)

Number of subjects included in analysis

435

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[3]

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

220.038

Confidence interval

level

95%

sides

2-sided

lower limit

28.757

upper limit

1683.639

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

Secondary: Percentage of participants with a IGA Clear response at Week 16

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End point title

Percentage of participants with a IGA Clear 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 with at least >= 2 category improvement relative to Baseline. Study participants with missing score at Week 16 were counted as nonresponders (NRI). The Randomized Set (RS) consisted of all randomized study participants.

End point type

Secondary

End point timeframe

At Week 16

End point values	Placebo (RS)	Bimekizumab dose regimen 1 (RS)
Number of subjects analysed	86	349
Units: percentage of participants
number (not applicable)	1.2	69.6

Statistical analysis 1

Statistical analysis description

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

Comparison groups

Bimekizumab dose regimen 1 (RS) v Placebo (RS)

Number of subjects included in analysis

435

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[4]

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

224.744

Confidence interval

level

95%

sides

2-sided

lower limit

30.13

upper limit

1676.425

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

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

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End point title

Percentage of participants with a PASI75 response at Week 4

End point description

A PASI75 responder was defined as a participant that achieved 75% reduction from Baseline in the PASI score. 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. Study participants with missing score at a given week were counted as nonresponders. The Randomized Set (RS) consisted of all randomized study participants.

End point type

Secondary

End point timeframe

At Week 4

End point values	Placebo (RS)	Bimekizumab dose regimen 1 (RS)
Number of subjects analysed	86	349
Units: percentage of participants
number (not applicable)	1.2	75.9

Statistical analysis 1

Statistical analysis description

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

Comparison groups

Bimekizumab dose regimen 1 (RS) v Placebo (RS)

Number of subjects included in analysis

435

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[5]

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

316.641

Confidence interval

level

95%

sides

2-sided

lower limit

39.423

upper limit

2543.254

Notes
[5] - P-values for the comparison of treatment groups 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

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End point title

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

End point description

A PRO measure, the PSD (further published as P-SIM) 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 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

At Week 16

End point values	Placebo (RS)	Bimekizumab dose regimen 1 (RS)
Number of subjects analysed	67	255
Units: percentage of participants
number (not applicable)	9.0	78.8

Statistical analysis 1

Statistical analysis description

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

Comparison groups

Bimekizumab dose regimen 1 (RS) v Placebo (RS)

Number of subjects included in analysis

322

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[6]

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

34.325

Confidence interval

level

95%

sides

2-sided

lower limit

14.22

upper limit

82.856

Notes
[6] - P-values for the comparison of treatment groups 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

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End point title

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

End point description

A PRO measure, the PSD (further published as P-SIM) 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 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

At Week 16

End point values	Placebo (RS)	Bimekizumab dose regimen 1 (RS)
Number of subjects analysed	72	278
Units: percentage of participants
number (not applicable)	5.6	75.5

Statistical analysis 1

Statistical analysis description

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

Comparison groups

Bimekizumab dose regimen 1 (RS) v Placebo (RS)

Number of subjects included in analysis

350

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[7]

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

43.497

Confidence interval

level

95%

sides

2-sided

lower limit

15.728

upper limit

120.295

Notes
[7] - P-values for the comparison of treatment groups 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 measure, the PSD (further published as P-SIM) 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 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

At Week 16

End point values	Placebo (RS)	Bimekizumab dose regimen 1 (RS)
Number of subjects analysed	70	286
Units: percentage of participants
number (not applicable)	5.7	78.0

Statistical analysis 1

Statistical analysis description

Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haensze (CMH) test with region and prior biologic exposure as stratification variables.

Comparison groups

Bimekizumab dose regimen 1 (RS) v Placebo (RS)

Number of subjects included in analysis

356

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[8]

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

60.946

Confidence interval

level

95%

sides

2-sided

lower limit

20.56

upper limit

180.669

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

Secondary: Percentage of participants with an IGA response (Clear or Almost Clear) at Week 16 for participants with scalp psoriasis (PSO) at Baseline

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End point title

Percentage of participants with an IGA response (Clear or Almost Clear) at Week 16 for participants with scalp psoriasis (PSO) 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.

End point type

Secondary

End point timeframe

At Week 16

End point values	Placebo (RS)	Bimekizumab dose regimen 1 (RS)
Number of subjects analysed	74	310
Units: percentage of participants
number (not applicable)	6.8	92.3

Statistical analysis 1

Statistical analysis description

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

Comparison groups

Bimekizumab dose regimen 1 (RS) v Placebo (RS)

Number of subjects included in analysis

384

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[9]

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

158

Confidence interval

level

95%

sides

2-sided

lower limit

49.263

upper limit

506.745

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

Secondary: Percentage of participants with a PASI90 response at Week 56 among Week 16 PASI90 responders

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End point title

Percentage of participants with a PASI90 response at Week 56 among Week 16 PASI90 responders

End point description

A PASI90 responder was defined as a participant that achieved 90% reduction from Baseline in the PASI score. Study participants with missing score at Week 56 or who met the criterion for relapse were counted as nonresponders (NRI). The Week 16 Responder Set (WK16ResS) consisted of all study participants who achieved a PASI90 response at Week 16 and received at least 1 dose of the IMP during the Randomized-Withdrawal Period at Week 16 or later. The hypothesis test for PASI90 at Week 56, based on Wk16ResS, compared pooled BKZ regimens (BKZ dose 1/1 + dose 1/2) versus placebo.

End point type

Secondary

End point timeframe

At Week 56

End point values	Bimekizumab dose regimen 1/Placebo (WK16ResS)	Bimekizumab dose regimen 1/dose regimen 2 (WK16ResS)	Bimekizumab dose regimen 1/dose regimen 1 (WK16ResS)	Bimekizumab dose regimen 1/ 1 + dose regimen 1/ 2 (WK16ResS)
Number of subjects analysed	105	100	106	206
Units: percentage of participants
number (not applicable)	16.2	91.0	86.8	88.8

Statistical analysis 1

Statistical analysis description

Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables. This statistical analysis is not controlled for multiplicity and is only nominal.

Comparison groups

Bimekizumab dose regimen 1/Placebo (WK16ResS) v Bimekizumab dose regimen 1/dose regimen 2 (WK16ResS)

Number of subjects included in analysis

205

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[10]

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

45.192

Confidence interval

level

95%

sides

2-sided

lower limit

18.622

upper limit

109.672

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

Statistical analysis 2

Statistical analysis description

Comparison groups

Bimekizumab dose regimen 1/Placebo (WK16ResS) v Bimekizumab dose regimen 1/dose regimen 1 (WK16ResS)

Number of subjects included in analysis

211

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[11]

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

49.297

Confidence interval

level

95%

sides

2-sided

lower limit

18.887

upper limit

128.673

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

Statistical analysis 3

Statistical analysis description

Comparison groups

Bimekizumab dose regimen 1/Placebo (WK16ResS) v Bimekizumab dose regimen 1/ 1 + dose regimen 1/ 2 (WK16ResS)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[12]

Method

Cochran-Mantel-Haenszel

Parameter type

Odds ratio (OR)

Point estimate

47.406

Confidence interval

level

95%

sides

2-sided

lower limit

22.087

upper limit

101.75

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

Secondary: Number of treatment-emergent adverse events (TEAEs) adjusted by duration of participant 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 participant 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 it provides 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 who received at least 1 dose of the IMP.

End point type

Secondary

End point timeframe

From Baseline to end of Initial Treatment Period (up to Week 16)

End point values	Placebo (SS)	Bimekizumab dose regimen 1 (SS)
Number of subjects analysed	86	349
Units: no. of new events per 100 subject-years
number (confidence interval 95%)	177.38 (123.55 to 246.69)	323.61 (281.60 to 370.11)

No statistical analyses for this end point

Secondary: Number of serious adverse events (SAEs) adjusted by duration of participant 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 participant exposure to study treatment during the Initial Treatment Period

End point description

End point type

Secondary

End point timeframe

From Baseline to end of Initial Treatment Period (up to Week 16)

End point values	Placebo (SS)	Bimekizumab dose regimen 1 (SS)
Number of subjects analysed	86	349
Units: no. of new events per 100 subject-years
number (confidence interval 95%)	7.66 (0.93 to 27.68)	5.59 (2.05 to 12.17)

No statistical analyses for this end point

Secondary: Number of TEAEs leading to withdrawal adjusted by duration of participant 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 participant 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 provides 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 who received at least 1 dose of the IMP. Here, '999' signifies that 95% CI could not be calculated for this outcome measure because number of TEAEs leading to withdrawal were 0.

End point type

Secondary

End point timeframe

From Baseline to end of Initial Treatment Period (up to Week 16)

End point values	Placebo (SS)	Bimekizumab dose regimen 1 (SS)
Number of subjects analysed	86	349
Units: no. of new events per 100 subject-years
number (confidence interval 95%)	0 (-999 to 999)	2.78 (0.57 to 8.12)

No statistical analyses for this end point

Secondary: Number of treatment-emergent adverse events (TEAEs) adjusted by duration of participant exposure to study treatment during the Randomized-Withdrawal Period

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End point title

Number of treatment-emergent adverse events (TEAEs) adjusted by duration of participant exposure to study treatment during the Randomized-Withdrawal Period

End point description

The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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 Week 16 Responder Set (WK16ResS) consisted of all study participants who achieved a PASI90 response at Week 16 and received at least 1 dose of the IMP during the Randomized-Withdrawal Period at Week 16 or later.

End point type

Secondary

End point timeframe

From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)

End point values	Placebo/Placebo (WK16ResS)	Bimekizumab dose regimen 1/Placebo (WK16ResS)	Bimekizumab dose regimen 1/dose regimen 2 (WK16ResS)	Bimekizumab dose regimen 1/dose regimen 1 (WK16ResS)
Number of subjects analysed	1	105	100	106
Units: no. of new events per 100 subject-years
number (confidence interval 95%)	144.37 (3.66 to 804.36)	242.11 (189.44 to 304.90)	224.87 (177.46 to 281.05)	208.88 (165.11 to 260.69)

No statistical analyses for this end point

Secondary: Number of serious adverse events (SAEs) adjusted by duration of participant exposure to study treatment during the Randomized-Withdrawal Period

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End point title

Number of serious adverse events (SAEs) adjusted by duration of participant exposure to study treatment during the Randomized-Withdrawal Period

End point description

The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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 Week 16 Responder Set (WK16ResS) consisted of all study participants who achieved a PASI90 response at Week 16 and received at least 1 dose of the IMP during the Randomized-Withdrawal Period at Week 16 or later. Here, '999' signifies that 95% CI could not be calculated for this outcome measure because number of serious adverse events were 0.

End point type

Secondary

End point timeframe

From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)

End point values	Placebo/Placebo (WK16ResS)	Bimekizumab dose regimen 1/Placebo (WK16ResS)	Bimekizumab dose regimen 1/dose regimen 2 (WK16ResS)	Bimekizumab dose regimen 1/dose regimen 1 (WK16ResS)
Number of subjects analysed	1	105	100	106
Units: no. of new events per 100 subject-years
number (confidence interval 95%)	0 (-999 to 999)	7.20 (1.96 to 18.43)	4.04 (0.83 to 11.80)	6.64 (2.16 to 15.50)

No statistical analyses for this end point

Secondary: Number of TEAEs leading to withdrawal adjusted by duration of participant exposure to study treatment during the Randomized-Withdrawal Period

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End point title

Number of TEAEs leading to withdrawal adjusted by duration of participant exposure to study treatment during the Randomized-Withdrawal Period

End point description

The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides 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 Week 16 Responder Set (WK16ResS) consisted of all study participants who achieved a PASI90 response at Week 16 and received at least 1 dose of the IMP during the Randomized-Withdrawal Period at Week 16 or later. Here, '999' signifies that 95% CI could not be calculated for this outcome measure because number of TEAEs leading to withdrawal were 0.

End point type

Secondary

End point timeframe

From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)

End point values	Placebo/Placebo (WK16ResS)	Bimekizumab dose regimen 1/Placebo (WK16ResS)	Bimekizumab dose regimen 1/dose regimen 2 (WK16ResS)	Bimekizumab dose regimen 1/dose regimen 1 (WK16ResS)
Number of subjects analysed	1	105	100	106
Units: no. of new events per 100 subject-years
number (confidence interval 95%)	0 (-999 to 999)	5.33 (1.10 to 15.58)	2.69 (0.33 to 9.71)	0 (-999 to 999)

No statistical analyses for this end point

Secondary: Number of treatment-emergent adverse events (TEAEs) adjusted by duration of participant exposure to study treatment during the Escape Treatment

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End point title

Number of treatment-emergent adverse events (TEAEs) adjusted by duration of participant exposure to study treatment during the Escape Treatment

End point description

The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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 Escape Study Participant Set (ESS) consisted of all study participants who received at least 1 dose of escape bimekizumab treatment either due to not achieving a PASI90 response at Week 16 or experiencing a relapse after entering the Randomized-Withdrawal Period.

End point type

Secondary

End point timeframe

From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)

End point values	Placebo Escape (ESS)	Bimekizumab dose regimen 1 Escape (ESS)	Bimekizumab dose regimen 1/ Placebo Escape (ESS)	Bimekizumab dose regimen 1/dose regimen 2 Escape (ESS)	Bimekizumab dose regimen 1/dose regimen 1 Escape (ESS)
Number of subjects analysed	81	23	67	4	7
Units: no. of new events per 100 subject-years
number (confidence interval 95%)	235.86 (164.29 to 328.03)	287.19 (143.36 to 513.86)	180.89 (115.90 to 269.15)	491.37 (101.33 to 1435.98)	349.52 (95.23 to 894.91)

No statistical analyses for this end point

Secondary: Number of serious adverse events (SAEs) adjusted by duration of participant exposure to study treatment during the Escape Treatment

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End point title

Number of serious adverse events (SAEs) adjusted by duration of participant exposure to study treatment during the Escape Treatment

End point description

The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provides 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 ESS consisted of all study participants who received at least 1 dose of escape bimekizumab treatment either due to not achieving a PASI90 response at Week 16 or experiencing a relapse after entering the Randomized-Withdrawal Period. Here, '999' signifies that 95% CI could not be calculated for this outcome measure because number of serious adverse events were 0.

End point type

Secondary

End point timeframe

From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)

End point values	Placebo Escape (ESS)	Bimekizumab dose regimen 1 Escape (ESS)	Bimekizumab dose regimen 1/ Placebo Escape (ESS)	Bimekizumab dose regimen 1/dose regimen 2 Escape (ESS)	Bimekizumab dose regimen 1/dose regimen 1 Escape (ESS)
Number of subjects analysed	81	23	67	4	7
Units: no. of new events per 100 subject-years
number (confidence interval 95%)	5.24 (0.13 to 29.22)	0 (-999 to 999)	0 (-999 to 999)	0 (-999 to 999)	0 (-999 to 999)

No statistical analyses for this end point

Secondary: Number of TEAEs leading to withdrawal adjusted by duration of participant exposure to study treatment during the Escape Treatment

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End point title

Number of TEAEs leading to withdrawal adjusted by duration of participant exposure to study treatment during the Escape Treatment

End point description

The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provides 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 ESS consisted of all study participants who received at least 1 dose of escape bimekizumab treatment either due to not achieving a PASI90 response at Week 16 or experiencing a relapse after entering the Randomized-Withdrawal Period. Here, '999' signifies that 95% CI could not be calculated for this outcome measure because number of TEAEs leading to withdrawal were 0.

End point type

Secondary

End point timeframe

From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)

End point values	Placebo Escape (ESS)	Bimekizumab dose regimen 1 Escape (ESS)	Bimekizumab dose regimen 1/ Placebo Escape (ESS)	Bimekizumab dose regimen 1/dose regimen 2 Escape (ESS)	Bimekizumab dose regimen 1/dose regimen 1 Escape (ESS)
Number of subjects analysed	81	23	67	4	7
Units: no. of new events per 100 subject-years
number (confidence interval 95%)	0 (-999 to 999)	18.77 (0.48 to 104.58)	0 (-999 to 999)	0 (-999 to 999)	0 (-999 to 999)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration)

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 Period).

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

19.0

Reporting group title

Placebo (SS)

Reporting group description

Reporting group title

Bimekizumab dose regimen 1 (SS)

Reporting group description

Reporting group title

Placebo/Placebo (WK16ResS)

Reporting group description

Reporting group title

Bimekizumab dose regimen 1/Placebo (WK16ResS)

Reporting group description

Reporting group title

Bimekizumab dose regimen 1/dose regimen 2 (WK16ResS)

Reporting group description

Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab dose regimen 2 during the Randomized-Withdrawal Period. Participants formed the WK16ResS. Participants receiving dose regimen 2 received placebo at pre-specified time points to maintain the blinding.

Reporting group title

Bimekizumab dose regimen 1/dose regimen 1 (WK16ResS)

Reporting group description

Reporting group title

Placebo Escape (ESS)

Reporting group description

Reporting group title

Bimekizumab dose regimen 1 Escape (ESS)

Reporting group description

Reporting group title

Bimekizumab dose regimen 1/ Placebo Escape (ESS)

Reporting group description

Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks. Participants formed the ESS.

Reporting group title

Bimekizumab dose regimen 1/dose regimen 2 Escape (ESS)

Reporting group description

Participants in this arm were randomized to bimekizumab dose regimen 1 during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab dose regimen 2 during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab dose regimen 1 for 12 weeks. Participants formed the ESS. Participants receiving dose regimen 2 received placebo at pre-specified time points to maintain the blinding.

Reporting group title

Bimekizumab dose regimen 1/dose regimen 1 Escape (ESS)

Reporting group description

Serious adverse events	Placebo (SS)	Bimekizumab dose regimen 1 (SS)	Placebo/Placebo (WK16ResS)	Bimekizumab dose regimen 1/Placebo (WK16ResS)	Bimekizumab dose regimen 1/dose regimen 2 (WK16ResS)	Bimekizumab dose regimen 1/dose regimen 1 (WK16ResS)	Placebo Escape (ESS)	Bimekizumab dose regimen 1 Escape (ESS)	Bimekizumab dose regimen 1/ Placebo Escape (ESS)	Bimekizumab dose regimen 1/dose regimen 2 Escape (ESS)	Bimekizumab dose regimen 1/dose regimen 1 Escape (ESS)
Total subjects affected by serious adverse events
subjects affected / exposed	2 / 86 (2.33%)	6 / 349 (1.72%)	0 / 1 (0.00%)	4 / 105 (3.81%)	3 / 100 (3.00%)	5 / 106 (4.72%)	1 / 81 (1.23%)	0 / 23 (0.00%)	0 / 67 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)
number of deaths (all causes)	0	0	0	0	0	0	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0	0	0	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
subjects affected / exposed	0 / 86 (0.00%)	0 / 349 (0.00%)	0 / 1 (0.00%)	0 / 105 (0.00%)	0 / 100 (0.00%)	1 / 106 (0.94%)	0 / 81 (0.00%)	0 / 23 (0.00%)	0 / 67 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Prostate cancer
subjects affected / exposed	0 / 86 (0.00%)	0 / 349 (0.00%)	0 / 1 (0.00%)	1 / 105 (0.95%)	0 / 100 (0.00%)	0 / 106 (0.00%)	0 / 81 (0.00%)	0 / 23 (0.00%)	0 / 67 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Humerus fracture
subjects affected / exposed	0 / 86 (0.00%)	1 / 349 (0.29%)	0 / 1 (0.00%)	0 / 105 (0.00%)	0 / 100 (0.00%)	0 / 106 (0.00%)	0 / 81 (0.00%)	0 / 23 (0.00%)	0 / 67 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury
subjects affected / exposed	0 / 86 (0.00%)	0 / 349 (0.00%)	0 / 1 (0.00%)	0 / 105 (0.00%)	0 / 100 (0.00%)	1 / 106 (0.94%)	0 / 81 (0.00%)	0 / 23 (0.00%)	0 / 67 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Myocardial infarction
subjects affected / exposed	1 / 86 (1.16%)	0 / 349 (0.00%)	0 / 1 (0.00%)	0 / 105 (0.00%)	0 / 100 (0.00%)	0 / 106 (0.00%)	0 / 81 (0.00%)	0 / 23 (0.00%)	0 / 67 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Mitral valve prolapse
subjects affected / exposed	1 / 86 (1.16%)	0 / 349 (0.00%)	0 / 1 (0.00%)	0 / 105 (0.00%)	0 / 100 (0.00%)	0 / 106 (0.00%)	0 / 81 (0.00%)	0 / 23 (0.00%)	0 / 67 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Acute myocardial infarction
subjects affected / exposed	0 / 86 (0.00%)	0 / 349 (0.00%)	0 / 1 (0.00%)	0 / 105 (0.00%)	1 / 100 (1.00%)	0 / 106 (0.00%)	0 / 81 (0.00%)	0 / 23 (0.00%)	0 / 67 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ischaemic cardiomyopathy
subjects affected / exposed	0 / 86 (0.00%)	0 / 349 (0.00%)	0 / 1 (0.00%)	0 / 105 (0.00%)	0 / 100 (0.00%)	0 / 106 (0.00%)	1 / 81 (1.23%)	0 / 23 (0.00%)	0 / 67 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	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	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	0 / 86 (0.00%)	0 / 349 (0.00%)	0 / 1 (0.00%)	0 / 105 (0.00%)	0 / 100 (0.00%)	0 / 106 (0.00%)	1 / 81 (1.23%)	0 / 23 (0.00%)	0 / 67 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	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	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Syncope
subjects affected / exposed	0 / 86 (0.00%)	0 / 349 (0.00%)	0 / 1 (0.00%)	0 / 105 (0.00%)	0 / 100 (0.00%)	0 / 106 (0.00%)	1 / 81 (1.23%)	0 / 23 (0.00%)	0 / 67 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	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	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Eye disorders
Retinal detachment
subjects affected / exposed	0 / 86 (0.00%)	1 / 349 (0.29%)	0 / 1 (0.00%)	1 / 105 (0.95%)	0 / 100 (0.00%)	0 / 106 (0.00%)	0 / 81 (0.00%)	0 / 23 (0.00%)	0 / 67 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cataract
subjects affected / exposed	0 / 86 (0.00%)	0 / 349 (0.00%)	0 / 1 (0.00%)	0 / 105 (0.00%)	0 / 100 (0.00%)	1 / 106 (0.94%)	0 / 81 (0.00%)	0 / 23 (0.00%)	0 / 67 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Gastrointestinal inflammation
subjects affected / exposed	0 / 86 (0.00%)	1 / 349 (0.29%)	0 / 1 (0.00%)	0 / 105 (0.00%)	0 / 100 (0.00%)	0 / 106 (0.00%)	0 / 81 (0.00%)	0 / 23 (0.00%)	0 / 67 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Diverticular perforation
subjects affected / exposed	0 / 86 (0.00%)	1 / 349 (0.29%)	0 / 1 (0.00%)	0 / 105 (0.00%)	0 / 100 (0.00%)	0 / 106 (0.00%)	0 / 81 (0.00%)	0 / 23 (0.00%)	0 / 67 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	0 / 86 (0.00%)	0 / 349 (0.00%)	0 / 1 (0.00%)	0 / 105 (0.00%)	2 / 100 (2.00%)	0 / 106 (0.00%)	0 / 81 (0.00%)	0 / 23 (0.00%)	0 / 67 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Duodenal ulcer haemorrhage
subjects affected / exposed	0 / 86 (0.00%)	0 / 349 (0.00%)	0 / 1 (0.00%)	0 / 105 (0.00%)	0 / 100 (0.00%)	0 / 106 (0.00%)	1 / 81 (1.23%)	0 / 23 (0.00%)	0 / 67 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	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	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Cholelithiasis
subjects affected / exposed	0 / 86 (0.00%)	1 / 349 (0.29%)	0 / 1 (0.00%)	0 / 105 (0.00%)	0 / 100 (0.00%)	0 / 106 (0.00%)	0 / 81 (0.00%)	0 / 23 (0.00%)	0 / 67 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
subjects affected / exposed	0 / 86 (0.00%)	0 / 349 (0.00%)	0 / 1 (0.00%)	1 / 105 (0.95%)	0 / 100 (0.00%)	0 / 106 (0.00%)	0 / 81 (0.00%)	0 / 23 (0.00%)	0 / 67 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Erythrodermic psoriasis
subjects affected / exposed	0 / 86 (0.00%)	0 / 349 (0.00%)	0 / 1 (0.00%)	1 / 105 (0.95%)	0 / 100 (0.00%)	0 / 106 (0.00%)	0 / 81 (0.00%)	0 / 23 (0.00%)	0 / 67 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
subjects affected / exposed	0 / 86 (0.00%)	0 / 349 (0.00%)	0 / 1 (0.00%)	0 / 105 (0.00%)	0 / 100 (0.00%)	1 / 106 (0.94%)	0 / 81 (0.00%)	0 / 23 (0.00%)	0 / 67 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Enterovirus infection
subjects affected / exposed	0 / 86 (0.00%)	1 / 349 (0.29%)	0 / 1 (0.00%)	0 / 105 (0.00%)	0 / 100 (0.00%)	0 / 106 (0.00%)	0 / 81 (0.00%)	0 / 23 (0.00%)	0 / 67 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 86 (0.00%)	1 / 349 (0.29%)	0 / 1 (0.00%)	0 / 105 (0.00%)	0 / 100 (0.00%)	0 / 106 (0.00%)	0 / 81 (0.00%)	0 / 23 (0.00%)	0 / 67 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Otitis media chronic
subjects affected / exposed	0 / 86 (0.00%)	0 / 349 (0.00%)	0 / 1 (0.00%)	0 / 105 (0.00%)	0 / 100 (0.00%)	1 / 106 (0.94%)	0 / 81 (0.00%)	0 / 23 (0.00%)	0 / 67 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Type 2 diabetes mellitus
subjects affected / exposed	0 / 86 (0.00%)	0 / 349 (0.00%)	0 / 1 (0.00%)	0 / 105 (0.00%)	0 / 100 (0.00%)	0 / 106 (0.00%)	1 / 81 (1.23%)	0 / 23 (0.00%)	0 / 67 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	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	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	Placebo (SS)	Bimekizumab dose regimen 1 (SS)	Placebo/Placebo (WK16ResS)	Bimekizumab dose regimen 1/Placebo (WK16ResS)	Bimekizumab dose regimen 1/dose regimen 2 (WK16ResS)	Bimekizumab dose regimen 1/dose regimen 1 (WK16ResS)	Placebo Escape (ESS)	Bimekizumab dose regimen 1 Escape (ESS)	Bimekizumab dose regimen 1/ Placebo Escape (ESS)	Bimekizumab dose regimen 1/dose regimen 2 Escape (ESS)	Bimekizumab dose regimen 1/dose regimen 1 Escape (ESS)
Total subjects affected by non serious adverse events
subjects affected / exposed	15 / 86 (17.44%)	66 / 349 (18.91%)	1 / 1 (100.00%)	34 / 105 (32.38%)	40 / 100 (40.00%)	34 / 106 (32.08%)	8 / 81 (9.88%)	5 / 23 (21.74%)	11 / 67 (16.42%)	3 / 4 (75.00%)	4 / 7 (57.14%)
Injury, poisoning and procedural complications
Rib fracture
subjects affected / exposed	0 / 86 (0.00%)	0 / 349 (0.00%)	0 / 1 (0.00%)	0 / 105 (0.00%)	0 / 100 (0.00%)	1 / 106 (0.94%)	0 / 81 (0.00%)	0 / 23 (0.00%)	0 / 67 (0.00%)	1 / 4 (25.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	1	0
Blood and lymphatic system disorders
Neutropenia
subjects affected / exposed	0 / 86 (0.00%)	2 / 349 (0.57%)	0 / 1 (0.00%)	0 / 105 (0.00%)	1 / 100 (1.00%)	0 / 106 (0.00%)	0 / 81 (0.00%)	1 / 23 (4.35%)	0 / 67 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	2	0	0	1	0	0	1	0	0	1
Gastrointestinal disorders
Dental caries
subjects affected / exposed	1 / 86 (1.16%)	0 / 349 (0.00%)	0 / 1 (0.00%)	0 / 105 (0.00%)	0 / 100 (0.00%)	0 / 106 (0.00%)	0 / 81 (0.00%)	0 / 23 (0.00%)	0 / 67 (0.00%)	1 / 4 (25.00%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	1	0
Skin and subcutaneous tissue disorders
Psoriasis
subjects affected / exposed	4 / 86 (4.65%)	1 / 349 (0.29%)	0 / 1 (0.00%)	3 / 105 (2.86%)	0 / 100 (0.00%)	1 / 106 (0.94%)	0 / 81 (0.00%)	1 / 23 (4.35%)	0 / 67 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)
occurrences all number	5	1	0	3	0	1	0	1	0	0	1
Seborrhoeic dermatitis
subjects affected / exposed	0 / 86 (0.00%)	1 / 349 (0.29%)	0 / 1 (0.00%)	3 / 105 (2.86%)	0 / 100 (0.00%)	3 / 106 (2.83%)	0 / 81 (0.00%)	0 / 23 (0.00%)	0 / 67 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	1	0	4	0	4	0	0	0	0	1
Rash papular
subjects affected / exposed	0 / 86 (0.00%)	0 / 349 (0.00%)	0 / 1 (0.00%)	0 / 105 (0.00%)	0 / 100 (0.00%)	0 / 106 (0.00%)	0 / 81 (0.00%)	0 / 23 (0.00%)	0 / 67 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1
Infections and infestations
Nasopharyngitis
subjects affected / exposed	4 / 86 (4.65%)	23 / 349 (6.59%)	0 / 1 (0.00%)	20 / 105 (19.05%)	23 / 100 (23.00%)	11 / 106 (10.38%)	1 / 81 (1.23%)	1 / 23 (4.35%)	2 / 67 (2.99%)	0 / 4 (0.00%)	0 / 7 (0.00%)
occurrences all number	4	27	0	28	31	12	1	1	2	0	0
Oral candidiasis
subjects affected / exposed	0 / 86 (0.00%)	21 / 349 (6.02%)	0 / 1 (0.00%)	6 / 105 (5.71%)	9 / 100 (9.00%)	12 / 106 (11.32%)	4 / 81 (4.94%)	1 / 23 (4.35%)	7 / 67 (10.45%)	0 / 4 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	23	0	6	18	20	5	1	8	0	0
Upper respiratory tract infection
subjects affected / exposed	7 / 86 (8.14%)	14 / 349 (4.01%)	1 / 1 (100.00%)	5 / 105 (4.76%)	8 / 100 (8.00%)	12 / 106 (11.32%)	3 / 81 (3.70%)	1 / 23 (4.35%)	2 / 67 (2.99%)	0 / 4 (0.00%)	1 / 7 (14.29%)
occurrences all number	7	14	1	6	9	17	3	1	2	0	1
Tinea pedis
subjects affected / exposed	0 / 86 (0.00%)	4 / 349 (1.15%)	0 / 1 (0.00%)	0 / 105 (0.00%)	0 / 100 (0.00%)	1 / 106 (0.94%)	0 / 81 (0.00%)	0 / 23 (0.00%)	0 / 67 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	4	0	0	0	1	0	0	0	0	1
Impetigo
subjects affected / exposed	1 / 86 (1.16%)	2 / 349 (0.57%)	0 / 1 (0.00%)	1 / 105 (0.95%)	0 / 100 (0.00%)	1 / 106 (0.94%)	0 / 81 (0.00%)	0 / 23 (0.00%)	0 / 67 (0.00%)	1 / 4 (25.00%)	0 / 7 (0.00%)
occurrences all number	1	2	0	1	0	1	0	0	0	1	0
Body tinea
subjects affected / exposed	0 / 86 (0.00%)	1 / 349 (0.29%)	0 / 1 (0.00%)	0 / 105 (0.00%)	1 / 100 (1.00%)	0 / 106 (0.00%)	0 / 81 (0.00%)	0 / 23 (0.00%)	0 / 67 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	1	0	0	1	0	0	0	0	0	1
Tinea capitis
subjects affected / exposed	0 / 86 (0.00%)	0 / 349 (0.00%)	0 / 1 (0.00%)	0 / 105 (0.00%)	0 / 100 (0.00%)	0 / 106 (0.00%)	0 / 81 (0.00%)	0 / 23 (0.00%)	0 / 67 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1

More information

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Were there any global substantial amendments to the protocol? Yes

06 Apr 2018

Protocol Amendment 2 (dated 06 Apr 2018) was implemented to incorporate the following key changes: • Updated name and contact information for Clinical Project Manager (CPM) • Extended the duration of the Screening Period, and therefore the overall study duration, by 1 week • Updated list of current treatment for psoriasis (PSO) to reflect changes in labeling and approved countries • Updated list of completed and ongoing bimekizumab studies to reflect completion of UP0042 • Clarified calculation of Psoriasis Area and Severity Index (PASI) response rates • Removed references to pharmacodynamic (PD) assessments as they were not conducted in this study • Updated Table 5-1 Schedule of study assessments to modify the visits at which the physical examination, tuberculosis (TB) questionnaire, body weight, electrocardiogram (ECG), and the Patient Symptom Diary (PSD) (daily) were assessed • Clarified that all visits from first dose through Week 24 would have a ±3 day visit window, while all visits from Week 28 through end of study would have a ±7 day window • Clarified the dosing window • Modified exclusion criterion to clarify exclusion of study participants who participated in other studies of bimekizumab, other medications (systemic or topical), or devices • Modified exclusion criteria pertaining to history of malignancy, systemic disease, and major depression • Added new withdrawal criteria for study participants with newly diagnosed inflammatory bowel disease (IBD) • Clarified withdrawal criteria for study participants with depression or suicidal ideation or behavior • Updated prohibited concomitant medications to include tildrakizumab and risankizumab • Corrected discrepancies between Section 8 Study procedures by visit and Table 5-1 Schedule of study assessments • Revised Psoriatic Arthritis Screening and Evaluation (PASE) questionnaire scoring • Clarified definition of abortion • Updated laboratory measurements to be performed

06 Apr 2018

Continuation of Protocol Amendment 2: • Provided additional details for requirements for investigational medicinal product (IMP) rechallenge in the event of potential drug-induced liver injury (PDILI) • Updated the definition of the Full Analysis Set (FAS) • Clarified regions for analyses 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, Double-Blind, Placebo-Controlled Study with an Initial Treatment Period Followed by a Randomized-Withdrawal Period 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) response at Week 16

Primary: Percentage of participants with an Investigator's Global Assessment (IGA) 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 a IGA Clear response at Week 16

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

Secondary: Percentage of participants with an IGA response (Clear or Almost Clear) at Week 16 for participants with scalp psoriasis (PSO) at Baseline

Secondary: Percentage of participants with a PASI90 response at Week 56 among Week 16 PASI90 responders

Secondary: Percentage of participants with a PASI90 response at Week 56 among Week 16 PASI90 responders

Secondary: Number of treatment-emergent adverse events (TEAEs) adjusted by duration of participant exposure to study treatment during the Initial Treatment Period

Secondary: Number of treatment-emergent adverse events (TEAEs) adjusted by duration of participant exposure to study treatment during the Initial Treatment Period

Secondary: Number of serious adverse events (SAEs) adjusted by duration of participant exposure to study treatment during the Initial Treatment Period

Secondary: Number of serious adverse events (SAEs) adjusted by duration of participant exposure to study treatment during the Initial Treatment Period

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

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

Secondary: Number of treatment-emergent adverse events (TEAEs) adjusted by duration of participant exposure to study treatment during the Randomized-Withdrawal Period

Secondary: Number of treatment-emergent adverse events (TEAEs) adjusted by duration of participant exposure to study treatment during the Randomized-Withdrawal Period

Secondary: Number of serious adverse events (SAEs) adjusted by duration of participant exposure to study treatment during the Randomized-Withdrawal Period

Secondary: Number of serious adverse events (SAEs) adjusted by duration of participant exposure to study treatment during the Randomized-Withdrawal Period

Secondary: Number of TEAEs leading to withdrawal adjusted by duration of participant exposure to study treatment during the Randomized-Withdrawal Period

Secondary: Number of TEAEs leading to withdrawal adjusted by duration of participant exposure to study treatment during the Randomized-Withdrawal Period

Secondary: Number of treatment-emergent adverse events (TEAEs) adjusted by duration of participant exposure to study treatment during the Escape Treatment

Secondary: Number of treatment-emergent adverse events (TEAEs) adjusted by duration of participant exposure to study treatment during the Escape Treatment

Secondary: Number of serious adverse events (SAEs) adjusted by duration of participant exposure to study treatment during the Escape Treatment

Secondary: Number of serious adverse events (SAEs) adjusted by duration of participant exposure to study treatment during the Escape Treatment

Secondary: Number of TEAEs leading to withdrawal adjusted by duration of participant exposure to study treatment during the Escape Treatment

Secondary: Number of TEAEs leading to withdrawal adjusted by duration of participant exposure to study treatment during the Escape Treatment

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study with an Initial Treatment Period Followed by a Randomized-Withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects with Moderate to Severe Chronic Plaque Psoriasis