Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2016-003392-22
Secondary ID [2] 0 0
PS0008
Universal Trial Number (UTN)
Trial acronym
BE SURE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Plaque Psoriasis 0 0
Moderate to Severe Plaque Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Week 16
Primary outcome [2] 0 0
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
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Week 16
Secondary outcome [1] 0 0
Percentage of Participants With a PASI90 Response at Week 24
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Percentage of Participants With an IGA Response (Clear or Almost Clear With at Least 2-category Improvement Relative to Baseline) at Week 24
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Percentage of Participants With a PASI75 Response at Week 4
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
Week 4
Secondary outcome [4] 0 0
Percentage of Participants With a PASI100 Response at Week 16
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
Week 16
Secondary outcome [5] 0 0
Percentage of Participants With a PASI100 Response at Week 24
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
Week 24
Secondary outcome [6] 0 0
Percentage of Participants With a PASI90 Response at Week 56
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
Week 56
Secondary outcome [7] 0 0
Percentage of Participants With an IGA Response (Clear or Almost Clear With at Least 2-category Improvement Relative to Baseline) at Week 56
Assessment method [7] 0 0
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.
Timepoint [7] 0 0
Week 56
Secondary outcome [8] 0 0
Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24
Assessment method [8] 0 0
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.
Timepoint [8] 0 0
From Baseline to Week 24
Secondary outcome [9] 0 0
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24
Assessment method [9] 0 0
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.
Timepoint [9] 0 0
From Baseline to Week 24
Secondary outcome [10] 0 0
Number of Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24
Assessment method [10] 0 0
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.
Timepoint [10] 0 0
From Baseline to Week 24
Secondary outcome [11] 0 0
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)
Assessment method [11] 0 0
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.
Timepoint [11] 0 0
From Baseline to Safety Follow-Up Visit (up to Week 72)
Secondary outcome [12] 0 0
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)
Assessment method [12] 0 0
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.
Timepoint [12] 0 0
From Baseline to Safety Follow-Up Visit (up to Week 72)
Secondary outcome [13] 0 0
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)
Assessment method [13] 0 0
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.
Timepoint [13] 0 0
From Baseline to Safety Follow-Up Visit (up to Week 72)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/02/2020
Sample size
Target
Accrual to date
Final
478
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Ps0008 008 - East Melbourne
Recruitment hospital [2] 0 0
Ps0008 004 - Fremantle
Recruitment hospital [3] 0 0
Ps0008 007 - Hectorville
Recruitment hospital [4] 0 0
Ps0008 010 - Kogarah
Recruitment hospital [5] 0 0
Ps0008 005 - Phillip
Recruitment hospital [6] 0 0
Ps0008 009 - Woolloongabba
Recruitment postcode(s) [1] 0 0
- East Melbourne
Recruitment postcode(s) [2] 0 0
- Fremantle
Recruitment postcode(s) [3] 0 0
- Hectorville
Recruitment postcode(s) [4] 0 0
- Kogarah
Recruitment postcode(s) [5] 0 0
- Phillip
Recruitment postcode(s) [6] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Oklahoma
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
Canada
State/province [16] 0 0
Calgary
Country [17] 0 0
Canada
State/province [17] 0 0
Mississauga
Country [18] 0 0
Canada
State/province [18] 0 0
Montréal
Country [19] 0 0
Canada
State/province [19] 0 0
Peterborough
Country [20] 0 0
Canada
State/province [20] 0 0
Toronto
Country [21] 0 0
Canada
State/province [21] 0 0
Waterloo
Country [22] 0 0
Canada
State/province [22] 0 0
Windsor
Country [23] 0 0
Canada
State/province [23] 0 0
Winnipeg
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
Country [25] 0 0
Germany
State/province [25] 0 0
Bonn
Country [26] 0 0
Germany
State/province [26] 0 0
Dresden
Country [27] 0 0
Germany
State/province [27] 0 0
Hamburg
Country [28] 0 0
Germany
State/province [28] 0 0
Lubeck
Country [29] 0 0
Germany
State/province [29] 0 0
Mahlow
Country [30] 0 0
Germany
State/province [30] 0 0
Osnabrück
Country [31] 0 0
Germany
State/province [31] 0 0
Schweinfurt
Country [32] 0 0
Hungary
State/province [32] 0 0
Budapest
Country [33] 0 0
Hungary
State/province [33] 0 0
Debrecen
Country [34] 0 0
Hungary
State/province [34] 0 0
Gyula
Country [35] 0 0
Hungary
State/province [35] 0 0
Szeged
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Gwangju
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Seoul
Country [38] 0 0
Poland
State/province [38] 0 0
Bialystok
Country [39] 0 0
Poland
State/province [39] 0 0
Bydgoszcz
Country [40] 0 0
Poland
State/province [40] 0 0
Gdansk
Country [41] 0 0
Poland
State/province [41] 0 0
Katowice
Country [42] 0 0
Poland
State/province [42] 0 0
Kraków
Country [43] 0 0
Poland
State/province [43] 0 0
Lublin
Country [44] 0 0
Poland
State/province [44] 0 0
Nowa Sól
Country [45] 0 0
Poland
State/province [45] 0 0
Szczecin
Country [46] 0 0
Poland
State/province [46] 0 0
Warszawa
Country [47] 0 0
Poland
State/province [47] 0 0
Wroclaw
Country [48] 0 0
Poland
State/province [48] 0 0
Lódz
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Saint Petersburg
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Saratov
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Yaroslavl
Country [52] 0 0
Taiwan
State/province [52] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
UCB Biopharma SRL
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Cares
Address 0 0
+1 844 599 2273 (UCB)
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?



Results publications and other study-related documents


Results are available at https://clinicaltrials.gov/study/NCT03412747