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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03412747
Other study ID # PS0008
Secondary ID 2016-003392-22
Status Completed
Phase Phase 3
First received
Last updated
Start date January 26, 2018
Est. completion date February 26, 2020

Study information

Verified date December 2023
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 478
Est. completion date February 26, 2020
Est. primary completion date February 7, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 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


Related Conditions & MeSH terms


Intervention

Drug:
Bimekizumab
Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.
Adalimumab
Adalimumab will be administered according to the labeling recommendations.
Other:
Placebo
Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).

Locations

Country Name City State
Australia Ps0008 008 East Melbourne
Australia Ps0008 004 Fremantle
Australia Ps0008 007 Hectorville
Australia Ps0008 010 Kogarah
Australia Ps0008 005 Phillip
Australia Ps0008 009 Woolloongabba
Canada Ps0008 659 Calgary
Canada Ps0008 663 Mississauga
Canada Ps0008 660 Montréal
Canada Ps0008 661 Peterborough
Canada Ps0008 662 Toronto
Canada Ps0008 664 Toronto
Canada Ps0008 657 Waterloo
Canada Ps0008 669 Windsor
Canada Ps0008 670 Windsor
Canada Ps0008 674 Winnipeg
Germany Ps0008 207 Berlin
Germany Ps0008 218 Bonn
Germany Ps0008 203 Dresden
Germany Ps0008 211 Hamburg
Germany Ps0008 220 Hamburg
Germany Ps0008 215 Lubeck
Germany Ps0008 213 Mahlow
Germany Ps0008 205 Osnabrück
Germany Ps0008 217 Schweinfurt
Hungary Ps0008 252 Budapest
Hungary Ps0008 254 Budapest
Hungary Ps0008 255 Budapest
Hungary Ps0008 256 Debrecen
Hungary Ps0008 251 Gyula
Hungary Ps0008 260 Szeged
Korea, Republic of Ps0008 702 Gwangju
Korea, Republic of Ps0008 700 Seoul
Poland Ps0008 355 Bialystok
Poland Ps0008 362 Bialystok
Poland Ps0008 371 Bydgoszcz
Poland Ps0008 352 Gdansk
Poland Ps0008 359 Katowice
Poland Ps0008 366 Katowice
Poland Ps0008 363 Kraków
Poland Ps0008 360 Lódz
Poland Ps0008 372 Lódz
Poland Ps0008 356 Lublin
Poland Ps0008 364 Nowa Sól
Poland Ps0008 353 Szczecin
Poland Ps0008 354 Warszawa
Poland Ps0008 365 Wroclaw
Poland Ps0008 367 Wroclaw
Poland Ps0008 373 Wroclaw
Russian Federation Ps0008 405 Saint Petersburg
Russian Federation Ps0008 401 Saratov
Russian Federation Ps0008 406 Yaroslavl
Taiwan Ps0008 754 Taipei
Taiwan Ps0008 755 Taipei
United States Ps0008 940 Beverly Massachusetts
United States Ps0008 906 Boca Raton Florida
United States Ps0008 925 Brighton Massachusetts
United States Ps0008 931 Dallas Texas
United States Ps0008 939 Danbury Connecticut
United States Ps0008 908 East Windsor New Jersey
United States Ps0008 957 Glendale Arizona
United States Ps0008 945 Greer South Carolina
United States Ps0008 924 Houston Texas
United States Ps0008 951 Houston Texas
United States Ps0008 927 Los Angeles California
United States Ps0008 932 Oklahoma City Oklahoma
United States Ps0008 905 Overland Park Kansas
United States Ps0008 929 Portland Oregon
United States Ps0008 961 Rocky Mount North Carolina
United States Ps0008 955 San Diego California
United States Ps0008 943 San Luis Obispo California
United States Ps0008 967 Santa Monica California
United States Ps0008 936 Tampa Florida
United States Ps0008 917 Troy Michigan
United States Ps0008 934 Washington District of Columbia
United States Ps0008 900 West Des Moines Iowa
United States Ps0008 935 Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Hungary,  Korea, Republic of,  Poland,  Russian Federation,  Taiwan, 

References & Publications (3)

Gordon KB, Langley RG, Warren RB, Okubo Y, Rosmarin D, Lebwohl M, Peterson L, Madden C, de Cuyper D, Davies O, Thaci D. Bimekizumab safety in patients with moderate to severe plaque psoriasis: Pooled data from up to three years of treatment in randomized — View Citation

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 Tr — View Citation

Thaci D, Vender R, de Rie MA, Conrad C, Pariser DM, Strober B, Vanvoorden V, Wang M, Madden C, de Cuyper D, Kimball AB. Safety and efficacy of bimekizumab through 2 years in patients with moderate-to-severe plaque psoriasis: longer-term results from the B — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at 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. Week 16
Primary 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 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. Week 16
Secondary Percentage of Participants With a PASI90 Response at 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. Week 24
Secondary Percentage of Participants With an IGA Response (Clear or Almost Clear With at Least 2-category Improvement Relative to Baseline) at 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. Week 24
Secondary Percentage of Participants With a PASI75 Response at 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. Week 4
Secondary Percentage of Participants With a PASI100 Response at 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. Week 16
Secondary Percentage of Participants With a PASI100 Response at 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. Week 24
Secondary Percentage of Participants With a PASI90 Response at 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. Week 56
Secondary Percentage of Participants With an IGA Response (Clear or Almost Clear With at Least 2-category Improvement Relative to Baseline) at 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. Week 56
Secondary Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment 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. From Baseline to Week 24
Secondary Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment 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. From Baseline to Week 24
Secondary Number of Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment 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. From Baseline to Week 24
Secondary 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) 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. From Baseline to Safety Follow-Up Visit (up to Week 72)
Secondary 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) 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. From Baseline to Safety Follow-Up Visit (up to Week 72)
Secondary 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) 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. From Baseline to Safety Follow-Up Visit (up to Week 72)
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