A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Patients With Chronic Plaque Psoriasis (BE ABLE 2)

• ClinicalTrials.gov Identifier: NCT03010527
• Recruitment Status: Completed
• First Posted: January 5, 2017
• Results First Posted: October 25, 2021
• Last Update Posted: October 18, 2022
• Sponsor: UCB Biopharma SRL
• Information provided by (Responsible Party): UCB Pharma ( UCB Biopharma SRL )

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Chronic Plaque Psoriasis
• Interventions: Drug: Bimekizumab; Other: Placebo
• Enrollment: 217

Participant Flow

Recruitment Details	The study started to enroll participants in December 2016 and concluded in September 2018. Among the 217 participants in PS0011, no participants were assigned to receive placebo.
Pre-assignment Details	Participant Flow refers to the Full Analysis Set (FAS), which consisted of all enrolled participants who received at least 1 dose of the investigational medicinal product (IMP) and had a valid measurement of the primary efficacy variable at Baseline of PS0011.

Arm/Group Title	Bimekizumab 64 mg Q4W	Bimekizumab 160 mg Q4W	Bimekizumab 320 mg Q4W
Arm/Group Description	Participants received bimekizumab 64 milligrams (mg) injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011.	Participants received bimekizumab 160 mg injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011.	Participants received bimekizumab 320 mg injections, sc every four weeks (Q4W). Participants receiving bimekizumab 320 mg Q4W and bimekizumab 480 mg Q4W, in PS0010 were assigned to receive bimekizumab 320 mg Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010.
Period Title: Overall Study
Started	15	111	91
Completed	15	92	75
Not Completed	0	19	16
Reason Not Completed
Death	0	0	1
Adverse Event	0	4	2
Protocol Violation	0	1	0
Lost to Follow-up	0	2	1
Withdrawal by Subject	0	3	4
WITHDRAWAL CRITERIA #9	0	4	6
WITHDRAWAL CRITERIA #12	0	4	2
PDILI and WITHDRAWAL CRITERIA #9	0	1	0

Baseline Characteristics

Arm/Group Title		Bimekizumab 64 mg Q4W	Bimekizumab 160 mg Q4W	Bimekizumab 320 mg Q4W	Total Title
Arm/Group Description		Participants received bimekizumab 64 milligrams (mg) injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011.	Participants received bimekizumab 160 mg injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011.	Participants received bimekizumab 320 mg injections, sc every four weeks (Q4W). Participants receiving bimekizumab 320 mg Q4W and bimekizumab 480 mg Q4W, in PS0010 were assigned to receive bimekizumab 320 mg Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010.	[Not Specified]
Overall Number of Baseline Participants		15	111	91	217
Baseline Analysis Population Description		Baseline characteristics refer to the Safety Set (SS) which consisted of all participants who received at least 1 dose of the investigational medicinal product (IMP) in PS0011.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants	111 participants	91 participants	217 participants
	<=18 years	0 0.0%	1 0.9%	2 2.2%	3 1.4%
	Between 18 and 65 years	14 93.3%	105 94.6%	77 84.6%	196 90.3%
	>=65 years	1 6.7%	5 4.5%	12 13.2%	18 8.3%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	15 participants	111 participants	91 participants	217 participants
		44.5 (14.7)	44.5 (12.8)	43.5 (14.7)	44.1 (13.7)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants	111 participants	91 participants	217 participants
	Female	6 40.0%	40 36.0%	31 34.1%	77 35.5%
	Male	9 60.0%	71 64.0%	60 65.9%	140 64.5%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants	111 participants	91 participants	217 participants
	American Indian /Alaskan native	0 0.0%	1 0.9%	1 1.1%	2 0.9%
	Asian	1 6.7%	11 9.9%	6 6.6%	18 8.3%
	Black	1 6.7%	0 0.0%	1 1.1%	2 0.9%
	White	13 86.7%	99 89.2%	83 91.2%	195 89.9%

Outcome Measures

1. Primary Outcome

Title	Incidence of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Treatment
Description	Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of PS0011 investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of PS0011 study medication. The exposure adjusted incidence rate (EAIR) is defined as the number of subjects (n) with a specific AE adjusted for the exposure and was scaled to 100 subject-years: where the numerator is the total number of subjects experiencing the AE and the denominator is the total time at risk scaled to 100 subject-years; that is, the total summation of individual subject-years at risk up to the first occurrence of the AE for subjects with that AE, and the total subject-years at risk for those subjects not experiencing that AE, divided by 100.
Time Frame	From Baseline until Safety Follow-Up Visit (up to Week 64)

Outcome Measure Data

Analysis Population Description

The Safety Set (SS) consisted of all participants who received at least 1 dose of the study medication in PS0011.

Arm/Group Title	Bimekizumab 64 mg Q4W (SS)	Bimekizumab 160 mg Q4W (SS)	Bimekizumab 320 mg Q4W (SS)
Arm/Group Description:	Participants received bimekizumab 64 milligrams (mg) injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who received at least one dose of the IMP formed the Safety Set (SS).	Participants received bimekizumab 160 mg injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants who received at least one dose of the IMP formed the SS.	Participants received bimekizumab 320 mg injections, sc every four weeks (Q4W). Participants receiving bimekizumab 320 mg Q4W and bimekizumab 480 mg Q4W, in PS0010 were assigned to receive bimekizumab 320 mg Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010. Participants who received at least one dose of the IMP formed the SS.
Overall Number of Participants Analyzed	15	111	91
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: no. of new events per 100 subject-years
	110.68; (53.08 to 203.55)	225.26; (182.88 to 274.53)	206.82; (162.95 to 258.86)

2. Secondary Outcome

Title	Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response Over Time
Description	The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. It averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale) and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. PASI90 response is defined to be equal to 1 if the percentage improvement from Baseline in the PASI scores is 90% or greater and 0 if the percentage improvement from Baseline is less than 90%. This Outcome Measure presents results relative to PS0010 Baseline starting at PS0011 Baseline by PS0010 Week 12 response status.
Time Frame	From Baseline during the Treatment Period (up to Week 48)

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of all enrolled participants who received at least 1 dose of the study medication in PS0011 and had a valid efficacy measurement for Psoriasis Area and Severity Index (PASI) at Baseline of PS0011.

Arm/Group Title	Bimekizumab 64 mg Q4W/Bimekizumab 64 mg Q4W/R (FAS)	Bimekizumab 160 mg Q4W/Bimekizumab 160 mg Q4W/R (FAS)	Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W/R (FAS)	Bimekizumab 480 mg Q4W/Bimekizumab 320 mg Q4W/R (FAS)	Placebo/Bimekizumab 160 mg Q4W/NR (FAS)	Bimekizumab 64 mg Q4W/Bimekizumab 160 mg Q4W/NR (FAS)	Bimekizumab 160 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS)	Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS)	Bimekizumab 480 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS)
Arm/Group Description:	Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants formed the Full Analysis Set (FAS).	Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS.	Participants who achieved PASI90 response at Week 12 and received bimekizumab 320 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.	Participants who achieved PASI90 response at Week 12 and received bimekizumab 480 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.	Participants who did not achieve PASI90 response at Week 12 and received placebo Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS.	Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS.	Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.	Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 320 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.	Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 480 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.
Overall Number of Participants Analyzed	15	55	33	30	37	19	14	6	8
Measure Type: Number; Unit of Measure: percentage of participants
PS0011 Baseline	100	100	100	100	0	0	0	0	0
Week 4	100	100	97.0	100	45.9	42.1	42.9	66.7	50.0
Week 8	100	96.4	100	100	67.6	73.7	57.1	83.3	50.0
Week 12	100	96.4	100	96.7	81.1	78.9	64.3	100	62.5
Week 16	100	92.7	100	96.7	83.8	78.9	64.3	100	62.5
Week 20	100	89.1	93.9	96.7	89.2	84.2	78.6	83.3	62.5
Week 24	100	85.5	97.0	96.7	83.8	78.9	71.4	83.3	75.0
Week 28	93.3	90.9	97.0	96.7	91.9	84.2	71.4	83.3	50.0
Week 32	100	89.1	97.0	93.3	91.9	73.7	71.4	83.3	50.0
Week 36	100	85.5	97.0	93.3	91.9	73.7	71.4	66.7	50.0
Week 40	100	83.6	87.9	86.7	89.2	78.9	71.4	83.3	50.0
Week 44	100	81.8	87.9	86.7	89.2	78.9	71.4	83.3	50.0
Week 48	100	80.0	87.9	86.7	91.9	68.4	71.4	66.7	50.0

3. Secondary Outcome

Title	Percentage of Participants With Investigator´s Global Assessment Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) Over Time
Description	The Investigator's Global Assessment (IGA) measures the overall 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 is defined as clear (0) or almost clear (1) with at least a two category improvement from Baseline. This Outcome Measure presents results relative to PS0010 Baseline starting at PS0011 Baseline by PS0010 Week 12 response status.
Time Frame	From Baseline during the Treatment Period (up to Week 48)

Outcome Measure Data

Analysis Population Description

The FAS consisted of all enrolled participants who received at least 1 dose of the study medication in PS0011 and had a valid efficacy measurement for PASI at Baseline of PS0011.

Arm/Group Title	Bimekizumab 64 mg Q4W/Bimekizumab 64 mg Q4W/R (FAS)	Bimekizumab 160 mg Q4W/Bimekizumab 160 mg Q4W/R (FAS)	Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W/R (FAS)	Bimekizumab 480 mg Q4W/Bimekizumab 320 mg Q4W/R (FAS)	Placebo/Bimekizumab 160 mg Q4W/NR (FAS)	Bimekizumab 64 mg Q4W/Bimekizumab 160 mg Q4W/NR (FAS)	Bimekizumab 160 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS)	Bimekizumab 320 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS)	Bimekizumab 480 mg Q4W/Bimekizumab 320 mg Q4W/NR (FAS)
Arm/Group Description:	Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants formed the Full Analysis Set (FAS).	Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS.	Participants who achieved PASI90 response at Week 12 and received bimekizumab 320 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.	Participants who achieved PASI90 response at Week 12 and received bimekizumab 480 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.	Participants who did not achieve PASI90 response at Week 12 and received placebo Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS.	Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants formed the FAS.	Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.	Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 320 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.	Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 480 mg Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants formed the FAS.
Overall Number of Participants Analyzed	15	55	33	30	37	19	14	6	8
Measure Type: Number; Unit of Measure: percentage of participants
PS0011 Baseline	100	96.4	100	100	5.4	10.5	35.7	50.0	25.0
Week 4	100	98.2	97.0	100	56.8	57.9	42.9	66.7	62.5
Week 8	100	96.4	97.0	100	75.7	84.2	57.1	83.3	62.5
Week 12	100	92.7	97.0	96.7	81.1	89.5	64.3	83.3	62.5
Week 16	100	90.9	97.0	96.7	83.8	78.9	57.1	66.7	62.5
Week 20	100	85.5	93.9	96.7	89.2	84.2	71.4	66.7	75.0
Week 24	100	81.8	97.0	93.3	83.8	84.2	64.3	83.3	62.5
Week 28	93.3	89.1	97.0	93.3	86.5	84.2	71.4	66.7	62.5
Week 32	100	85.5	93.9	93.3	89.2	78.9	71.4	66.7	50.0
Week 36	100	81.8	90.9	93.3	86.5	78.9	71.4	66.7	37.5
Week 40	100	83.6	87.9	86.7	86.5	78.9	71.4	66.7	50.0
Week 44	100	81.8	87.9	86.7	83.8	78.9	71.4	66.7	50.0
Week 48	100	78.2	87.9	86.7	89.2	68.4	71.4	66.7	62.5

Adverse Events

Time Frame	From PS0011 Baseline and up to Safety-Follow Up (SFU) (up to Week 64)
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Bimekizumab 64 mg Q4W (SS)		Bimekizumab 160 mg Q4W (SS)		Bimekizumab 320 mg Q4W (SS)
Arm/Group Description	Participants received bimekizumab 64 milligrams (mg) injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 64 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 64 mg Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who received at least one dose of the IMP formed the Safety Set (SS).		Participants received bimekizumab 160 mg injections, sc every four weeks (Q4W). Participants who achieved PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg with loading dose (w/LD) Q4W in PS0010, were assigned to bimekizumab 160 mg Q4W in PS0011. Participants who did not achieve PASI90 response at Week 12 and received bimekizumab 160 mg Q4W or bimekizumab 160 mg w/LD Q4W in PS0010, were assigned to bimekizumab 320 mg Q4W in PS0011. Participants who received at least one dose of the IMP formed the SS.		Participants received bimekizumab 320 mg injections, sc every four weeks (Q4W). Participants receiving bimekizumab 320 mg Q4W and bimekizumab 480 mg Q4W, in PS0010 were assigned to receive bimekizumab 320 mg Q4W in PS0011, regardless of their PASI90 response at Week 12 in PS0010. Participants who received at least one dose of the IMP formed the SS.
All-Cause Mortality
	Bimekizumab 64 mg Q4W (SS)		Bimekizumab 160 mg Q4W (SS)		Bimekizumab 320 mg Q4W (SS)
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/15 (0.00%)		0/111 (0.00%)		2/91 (2.20%)
Serious Adverse Events
	Bimekizumab 64 mg Q4W (SS)		Bimekizumab 160 mg Q4W (SS)		Bimekizumab 320 mg Q4W (SS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/15 (6.67%)		7/111 (6.31%)		7/91 (7.69%)
Cardiac disorders
Cardiac failure * 1	0/15 (0.00%)	0	1/111 (0.90%)	1	0/91 (0.00%)	0
Eye disorders
Cataract * 1	0/15 (0.00%)	0	0/111 (0.00%)	0	1/91 (1.10%)	1
General disorders
Non-cardiac chest pain * 1	1/15 (6.67%)	1	0/111 (0.00%)	0	0/91 (0.00%)	0
Infections and infestations
Otitis externa bacterial * 1	0/15 (0.00%)	0	0/111 (0.00%)	0	1/91 (1.10%)	1
Staphylococcal abscess * 1	0/15 (0.00%)	0	1/111 (0.90%)	1	0/91 (0.00%)	0
Injury, poisoning and procedural complications
Humerus fracture * 1	0/15 (0.00%)	0	0/111 (0.00%)	0	1/91 (1.10%)	1
Tibia fracture * 1	0/15 (0.00%)	0	0/111 (0.00%)	0	1/91 (1.10%)	1
Investigations
Hepatic enzyme increased * 1	0/15 (0.00%)	0	1/111 (0.90%)	1	0/91 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia * 1	0/15 (0.00%)	0	1/111 (0.90%)	1	0/91 (0.00%)	0
Nervous system disorders
Carpal tunnel syndrome * 1	0/15 (0.00%)	0	0/111 (0.00%)	0	1/91 (1.10%)	2
Renal and urinary disorders
IgA nephropathy * 1	0/15 (0.00%)	0	1/111 (0.90%)	1	0/91 (0.00%)	0
Nephrolithiasis * 1	0/15 (0.00%)	0	1/111 (0.90%)	1	0/91 (0.00%)	0
Ureterolithiasis * 1	0/15 (0.00%)	0	1/111 (0.90%)	1	0/91 (0.00%)	0
Renal colic * 1	0/15 (0.00%)	0	1/111 (0.90%)	2	0/91 (0.00%)	0
Reproductive system and breast disorders
Uterine cervix stenosis * 1	0/15 (0.00%)	0	1/111 (0.90%)	1	0/91 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnoea * 1	0/15 (0.00%)	0	0/111 (0.00%)	0	1/91 (1.10%)	2
Respiratory failure * 1	0/15 (0.00%)	0	0/111 (0.00%)	0	1/91 (1.10%)	1
Surgical and medical procedures
Abortion induced * 1	0/15 (0.00%)	0	0/111 (0.00%)	0	1/91 (1.10%)	1
Vascular disorders
Circulatory collapse * 1	0/15 (0.00%)	0	0/111 (0.00%)	0	1/91 (1.10%)	1
Hypovolaemic shock * 1	0/15 (0.00%)	0	0/111 (0.00%)	0	1/91 (1.10%)	1
1 Term from vocabulary, MedDRA19.0; * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Bimekizumab 64 mg Q4W (SS)		Bimekizumab 160 mg Q4W (SS)		Bimekizumab 320 mg Q4W (SS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/15 (66.67%)		56/111 (50.45%)		51/91 (56.04%)
Ear and labyrinth disorders
External ear inflammation * 1	1/15 (6.67%)	1	0/111 (0.00%)	0	1/91 (1.10%)	1
Gastrointestinal disorders
Diarrhoea * 1	1/15 (6.67%)	1	0/111 (0.00%)	0	1/91 (1.10%)	1
Flatulence * 1	1/15 (6.67%)	1	0/111 (0.00%)	0	0/91 (0.00%)	0
Hepatobiliary disorders
Non-alcoholic fatty liver * 1	1/15 (6.67%)	1	1/111 (0.90%)	1	0/91 (0.00%)	0
Infections and infestations
Oral candidiasis * 1	1/15 (6.67%)	2	13/111 (11.71%)	17	15/91 (16.48%)	19
Skin candida * 1	1/15 (6.67%)	1	0/111 (0.00%)	0	0/91 (0.00%)	0
Angular cheilitis * 1	1/15 (6.67%)	1	2/111 (1.80%)	3	0/91 (0.00%)	0
Gingivitis * 1	1/15 (6.67%)	1	0/111 (0.00%)	0	0/91 (0.00%)	0
Vulvovaginal mycotic infection * 1	1/15 (6.67%)	2	1/111 (0.90%)	1	0/91 (0.00%)	0
Nasopharyngitis * 1	2/15 (13.33%)	4	15/111 (13.51%)	20	11/91 (12.09%)	14
Upper respiratory tract infection * 1	1/15 (6.67%)	1	10/111 (9.01%)	12	9/91 (9.89%)	12
Pharyngitis * 1	1/15 (6.67%)	1	1/111 (0.90%)	1	3/91 (3.30%)	3
Urinary tract infection * 1	2/15 (13.33%)	3	1/111 (0.90%)	1	1/91 (1.10%)	2
Respiratory tract infection viral * 1	1/15 (6.67%)	1	1/111 (0.90%)	1	1/91 (1.10%)	1
Injury, poisoning and procedural complications
Joint injury * 1	1/15 (6.67%)	1	0/111 (0.00%)	0	0/91 (0.00%)	0
Procedural pain * 1	1/15 (6.67%)	2	0/111 (0.00%)	0	0/91 (0.00%)	0
Investigations
Gamma-glutamyl-transferase increased * 1	1/15 (6.67%)	1	4/111 (3.60%)	6	3/91 (3.30%)	4
Metabolism and nutrition disorders
Hyperphagia * 1	1/15 (6.67%)	1	0/111 (0.00%)	0	0/91 (0.00%)	0
Musculoskeletal and connective tissue disorders
Arthralgia * 1	0/15 (0.00%)	0	3/111 (2.70%)	4	6/91 (6.59%)	7
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour * 1	1/15 (6.67%)	1	0/111 (0.00%)	0	0/91 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain * 1	0/15 (0.00%)	0	6/111 (5.41%)	6	6/91 (6.59%)	8
Skin and subcutaneous tissue disorders
Dermatitis contact * 1	1/15 (6.67%)	1	5/111 (4.50%)	6	3/91 (3.30%)	3
Seborrhoeic dermatitis * 1	1/15 (6.67%)	1	3/111 (2.70%)	4	2/91 (2.20%)	2
Pruritus generalised * 1	1/15 (6.67%)	1	0/111 (0.00%)	0	1/91 (1.10%)	1
Psoriasis * 1	2/15 (13.33%)	2	5/111 (4.50%)	6	5/91 (5.49%)	5
Vascular disorders
Hypertension * 1	2/15 (13.33%)	2	8/111 (7.21%)	10	4/91 (4.40%)	4
1 Term from vocabulary, MedDRA19.0; * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

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

Publications of Results:

Blauvelt A, Papp KA, Merola JF, Gottlieb AB, Cross N, Madden C, Wang M, Cioffi C, Griffiths CEM. Bimekizumab for patients with moderate to severe plaque psoriasis: 60-week results from BE ABLE 2, a randomized, double-blinded, placebo-controlled, phase 2b extension study. J Am Acad Dermatol. 2020 Nov;83(5):1367-1374. doi: 10.1016/j.jaad.2020.05.105. Epub 2020 May 29.

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

• Responsible Party: UCB Pharma ( UCB Biopharma SRL )
• ClinicalTrials.gov Identifier: NCT03010527
• Other Study ID Numbers: PS0011; 2016-001892-57 ( EudraCT Number )
• First Submitted: January 3, 2017
• First Posted: January 5, 2017
• Results First Submitted: September 24, 2021
• Results First Posted: October 25, 2021
• Last Update Posted: October 18, 2022