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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03412747
Registration number
NCT03412747
Ethics application status
Date submitted
22/01/2018
Date registered
26/01/2018
Date last updated
20/12/2023
Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
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Scientific title
A Phase 3, Multicenter, Randomized, Double-Blind Study With an Active-Controlled Initial Treatment Period Followed by a Dose-Blind Maintenance Treatment Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
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Secondary ID [1]
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2016-003392-22
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Secondary ID [2]
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PS0008
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Universal Trial Number (UTN)
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Trial acronym
BE SURE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Plaque Psoriasis
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Moderate to Severe Plaque Psoriasis
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Bimekizumab
Treatment: Drugs - Adalimumab
Other interventions - Placebo
Experimental: Bimekizumab Arm 1 - Subjects will receive bimekizumab dose regimen 1 for 56 weeks. Subjects will receive placebo at pre-specified time-points to maintain the blinding.
Experimental: Bimekizumab Arm 2 - Subjects will receive bimekizumab dose regimen 1 for 16 weeks and will proceed with bimekizumab dose regimen 2 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.
Active Comparator: Adalimumab Arm - Subjects will receive adalimumab for 24 weeks and will then receive bimekizumab dose regimen 1 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.
Treatment: Drugs: Bimekizumab
Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.
Treatment: Drugs: Adalimumab
Adalimumab will be administered according to the labeling recommendations.
Other interventions: Placebo
Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16
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Assessment method [1]
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The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
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Timepoint [1]
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Week 16
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Primary outcome [2]
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Percentage of Participants With an Investigator's Global Assessment (IGA) Response (Clear or Almost Clear With at Least 2-Category Improvement Relative to Baseline) at Week 16
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Assessment method [2]
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The IGA measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline at Week 16.
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Timepoint [2]
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Week 16
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Secondary outcome [1]
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Percentage of Participants With a PASI90 Response at Week 24
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Assessment method [1]
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The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
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Timepoint [1]
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Week 24
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Secondary outcome [2]
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Percentage of Participants With an IGA Response (Clear or Almost Clear With at Least 2-category Improvement Relative to Baseline) at Week 24
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Assessment method [2]
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The IGA measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as clear [0] with at least a two-category improvement from Baseline at Week 24.
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Timepoint [2]
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Week 24
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Secondary outcome [3]
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Percentage of Participants With a PASI75 Response at Week 4
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Assessment method [3]
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The PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
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Timepoint [3]
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Week 4
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Secondary outcome [4]
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Percentage of Participants With a PASI100 Response at Week 16
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Assessment method [4]
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The PASI100 response assessments are based on a 100% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
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Timepoint [4]
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Week 16
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Secondary outcome [5]
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Percentage of Participants With a PASI100 Response at Week 24
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Assessment method [5]
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The PASI100 response assessments are based on a 100% improvement in the PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
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Timepoint [5]
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Week 24
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Secondary outcome [6]
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Percentage of Participants With a PASI90 Response at Week 56
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Assessment method [6]
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PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. Body divided into 4 areas: head/arms/trunk to groin/and legs to top of buttocks. Assignment of an average score for the redness/thickness/scaling for each of the 4 body areas with a score of 0 (clear)-4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0-6 scale. Final PASI=average redness/thickness/scaliness of the psoriatic skin lesions multiplied by the involved psoriasis area score of the respective section and weighted by the percentage of the person's affected skin for the respective section. The min possible PASI score is 0=no disease, max score is 72=maximal disease.
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Timepoint [6]
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Week 56
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Secondary outcome [7]
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Percentage of Participants With an IGA Response (Clear or Almost Clear With at Least 2-category Improvement Relative to Baseline) at Week 56
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Assessment method [7]
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IGA measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0=clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1=almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2=mild thickening, pink to light red coloration and predominately fine scaling, 3=moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4=severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as clear [0]/almost clear [1] with at least a 2-category improvement from Baseline at Wk56.
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Timepoint [7]
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Week 56
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Secondary outcome [8]
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Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24
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Assessment method [8]
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The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
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Timepoint [8]
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From Baseline to Week 24
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Secondary outcome [9]
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Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24
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Assessment method [9]
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The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
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Timepoint [9]
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From Baseline to Week 24
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Secondary outcome [10]
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Number of Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24
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Assessment method [10]
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The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
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Timepoint [10]
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From Baseline to Week 24
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Secondary outcome [11]
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Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Safety Follow-Up Visit (up to Week 72)
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Assessment method [11]
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The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
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Timepoint [11]
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From Baseline to Safety Follow-Up Visit (up to Week 72)
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Secondary outcome [12]
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Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Safety Follow-Up Visit (up to Week 72)
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Assessment method [12]
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The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
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Timepoint [12]
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From Baseline to Safety Follow-Up Visit (up to Week 72)
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Secondary outcome [13]
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Number of Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Safety Follow-Up Visit (up to Week 72)
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Assessment method [13]
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The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
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Timepoint [13]
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From Baseline to Safety Follow-Up Visit (up to Week 72)
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Eligibility
Key inclusion criteria
- Must be at least 18 years of age
- Chronic plaque PSO for at least 6 months prior to the Screening Visit
- Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO
>=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale
- Subject is a candidate for systemic PSO therapy and/or phototherapy
- Female subject of child bearing potential must be willing to use highly effective
method of contraception
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Subject has a known hypersensitivity to any excipients of bimekizumab or adalimumab
- Subject has an active infection (except common cold), a serious infection, or a
history of opportunistic or recurrent chronic infections
- Subject has concurrent acute or chronic viral hepatitis B or C or human
immunodeficiency virus (HIV) infection
- Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB
infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
- Subject has any other condition, including medical or psychiatric, which, in the
Investigator's judgment, would make the subject unsuitable for inclusion in the study
- Subject has had previous exposure to adalimumab
- Presence of active suicidal ideation or positive suicide behavior
- Presence of moderately severe major depression or severe major depression
- Subject has any active malignancy or history of malignancy within 5 years prior to the
Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell
carcinoma, or in situ cervical cancer
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/01/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/02/2020
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Sample size
Target
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Accrual to date
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Final
478
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Ps0008 008 - East Melbourne
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Recruitment hospital [2]
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Ps0008 004 - Fremantle
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Recruitment hospital [3]
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Ps0008 007 - Hectorville
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Recruitment hospital [4]
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Ps0008 010 - Kogarah
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Recruitment hospital [5]
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Ps0008 005 - Phillip
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Recruitment hospital [6]
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Ps0008 009 - Woolloongabba
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Recruitment postcode(s) [1]
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- East Melbourne
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Recruitment postcode(s) [2]
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- Fremantle
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Recruitment postcode(s) [3]
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- Hectorville
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Recruitment postcode(s) [4]
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- Kogarah
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Recruitment postcode(s) [5]
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- Phillip
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Recruitment postcode(s) [6]
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- Woolloongabba
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Recruitment outside Australia
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United States of America
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Arizona
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California
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United States of America
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Connecticut
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United States of America
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District of Columbia
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United States of America
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Florida
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Iowa
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Kansas
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Massachusetts
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Michigan
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New Jersey
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North Carolina
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Oklahoma
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Oregon
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Texas
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Canada
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Calgary
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Canada
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Mississauga
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Canada
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Montréal
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Canada
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Peterborough
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Toronto
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Waterloo
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Canada
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Windsor
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Winnipeg
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Lubeck
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Germany
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Mahlow
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Germany
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Osnabrück
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Germany
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Gyula
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Hungary
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Szeged
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Korea, Republic of
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Gwangju
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Seoul
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Bialystok
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Lublin
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Nowa Sól
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Szczecin
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Lódz
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saratov
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Russian Federation
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Yaroslavl
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Taiwan
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
UCB Biopharma SRL
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a study to compare the efficacy of bimekizumab versus adalimumab in the treatment of
subjects with moderate to severe chronic plaque psoriasis (PSO).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03412747
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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UCB Cares
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Address
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+1 844 599 2273 (UCB)
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03412747
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