A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
- Conditions
- Chronic Plaque PsoriasisModerate to Severe Plaque Psoriasis
- Interventions
- Registration Number
- NCT03412747
- Lead Sponsor
- UCB Biopharma SRL
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 478
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bimekizumab Arm 2 Placebo 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. Bimekizumab Arm 1 Placebo Subjects will receive bimekizumab dose regimen 1 for 56 weeks. Subjects will receive placebo at pre-specified time-points to maintain the blinding. Bimekizumab Arm 1 Bimekizumab Subjects will receive bimekizumab dose regimen 1 for 56 weeks. Subjects will receive placebo at pre-specified time-points to maintain the blinding. Adalimumab Arm Bimekizumab 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. Adalimumab Arm Adalimumab 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. Adalimumab Arm Placebo 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. Bimekizumab Arm 2 Bimekizumab 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 Week 16 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.
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 Week 16 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With a PASI90 Response at Week 24 Week 24 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.
Percentage of Participants With an IGA Response (Clear or Almost Clear With at Least 2-category Improvement Relative to Baseline) at Week 24 Week 24 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.
Percentage of Participants With a PASI75 Response at Week 4 Week 4 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.
Percentage of Participants With a PASI100 Response at Week 16 Week 16 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.
Percentage of Participants With a PASI100 Response at Week 24 Week 24 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.
Percentage of Participants With a PASI90 Response at Week 56 Week 56 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.
Percentage of Participants With an IGA Response (Clear or Almost Clear With at Least 2-category Improvement Relative to Baseline) at Week 56 Week 56 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.
Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24 From Baseline to Week 24 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.
Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24 From Baseline to Week 24 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.
Number of Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24 From Baseline to Week 24 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.
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) From Baseline to Safety Follow-Up Visit (up to Week 72) 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.
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) From Baseline to Safety Follow-Up Visit (up to Week 72) 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.
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) From Baseline to Safety Follow-Up Visit (up to Week 72) 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.
Trial Locations
- Locations (77)
Ps0008 905
🇺🇸Overland Park, Kansas, United States
Ps0008 755
🇨🇳Taipei, Taiwan
Ps0008 260
🇭🇺Szeged, Hungary
Ps0008 359
🇵🇱Katowice, Poland
Ps0008 371
🇵🇱Bydgoszcz, Poland
Ps0008 366
🇵🇱Katowice, Poland
Ps0008 364
🇵🇱Nowa Sól, Poland
Ps0008 354
🇵🇱Warszawa, Poland
Ps0008 365
🇵🇱Wrocław, Poland
Ps0008 256
🇭🇺Debrecen, Hungary
Ps0008 355
🇵🇱Białystok, Poland
Ps0008 362
🇵🇱Białystok, Poland
Ps0008 255
🇭🇺Budapest, Hungary
Ps0008 251
🇭🇺Gyula, Hungary
Ps0008 352
🇵🇱Gdańsk, Poland
Ps0008 927
🇺🇸Los Angeles, California, United States
Ps0008 957
🇺🇸Glendale, Arizona, United States
Ps0008 935
🇺🇸Winston-Salem, North Carolina, United States
Ps0008 211
🇩🇪Hamburg, Germany
Ps0008 353
🇵🇱Szczecin, Poland
Ps0008 010
🇦🇺Kogarah, Australia
Ps0008 908
🇺🇸East Windsor, New Jersey, United States
Ps0008 004
🇦🇺Fremantle, Australia
Ps0008 943
🇺🇸San Luis Obispo, California, United States
Ps0008 934
🇺🇸Washington, District of Columbia, United States
Ps0008 363
🇵🇱Kraków, Poland
Ps0008 356
🇵🇱Lublin, Poland
Ps0008 367
🇵🇱Wrocław, Poland
Ps0008 360
🇵🇱Łódź, Poland
Ps0008 372
🇵🇱Łódź, Poland
Ps0008 702
🇰🇷Gwangju, Korea, Republic of
Ps0008 660
🇨🇦Montréal, Canada
Ps0008 203
🇩🇪Dresden, Germany
Ps0008 009
🇦🇺Woolloongabba, Australia
Ps0008 664
🇨🇦Toronto, Canada
Ps0008 932
🇺🇸Oklahoma City, Oklahoma, United States
Ps0008 220
🇩🇪Hamburg, Germany
Ps0008 205
🇩🇪Osnabrück, Germany
Ps0008 670
🇨🇦Windsor, Canada
Ps0008 924
🇺🇸Houston, Texas, United States
Ps0008 405
🇷🇺Saint Petersburg, Russian Federation
Ps0008 669
🇨🇦Windsor, Canada
Ps0008 406
🇷🇺Yaroslavl, Russian Federation
Ps0008 254
🇭🇺Budapest, Hungary
Ps0008 005
🇦🇺Phillip, Australia
Ps0008 657
🇨🇦Waterloo, Canada
Ps0008 207
🇩🇪Berlin, Germany
Ps0008 218
🇩🇪Bonn, Germany
Ps0008 961
🇺🇸Rocky Mount, North Carolina, United States
Ps0008 252
🇭🇺Budapest, Hungary
Ps0008 008
🇦🇺East Melbourne, Australia
Ps0008 661
🇨🇦Peterborough, Canada
Ps0008 663
🇨🇦Mississauga, Canada
Ps0008 662
🇨🇦Toronto, Canada
Ps0008 955
🇺🇸San Diego, California, United States
Ps0008 900
🇺🇸West Des Moines, Iowa, United States
Ps0008 967
🇺🇸Santa Monica, California, United States
Ps0008 939
🇺🇸Danbury, Connecticut, United States
Ps0008 936
🇺🇸Tampa, Florida, United States
Ps0008 925
🇺🇸Brighton, Massachusetts, United States
Ps0008 906
🇺🇸Boca Raton, Florida, United States
Ps0008 940
🇺🇸Beverly, Massachusetts, United States
Ps0008 917
🇺🇸Troy, Michigan, United States
Ps0008 931
🇺🇸Dallas, Texas, United States
Ps0008 929
🇺🇸Portland, Oregon, United States
Ps0008 007
🇦🇺Hectorville, Australia
Ps0008 945
🇺🇸Greer, South Carolina, United States
Ps0008 659
🇨🇦Calgary, Canada
Ps0008 215
🇩🇪Lubeck, Germany
Ps0008 674
🇨🇦Winnipeg, Canada
Ps0008 213
🇩🇪Mahlow, Germany
Ps0008 217
🇩🇪Schweinfurt, Germany
Ps0008 700
🇰🇷Seoul, Korea, Republic of
Ps0008 373
🇵🇱Wrocław, Poland
Ps0008 401
🇷🇺Saratov, Russian Federation
Ps0008 754
🇨🇳Taipei, Taiwan
Ps0008 951
🇺🇸Houston, Texas, United States