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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03370133
Other study ID # PS0009
Secondary ID 2016-003425-42
Status Completed
Phase Phase 3
First received
Last updated
Start date December 6, 2017
Est. completion date December 13, 2019

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 placebo and an active comparator in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).


Recruitment information / eligibility

Status Completed
Enrollment 567
Est. completion date December 13, 2019
Est. primary completion date January 8, 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 psoriasis (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 an active infection (except common cold), a recent 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 - 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
Bimekizumab will be provided at pre-specified time intervals.
Ustekinumab
Ustekinumab will be provided as dose 1 for subjects weighing <=100 kg and as dose 2 for subjects weighing >100 kg at pre-specified time intervals.
Other:
Placebo
Subjects will receive Placebo at pre-specified time points.

Locations

Country Name City State
Australia Ps0009 004 Fremantle
Australia Ps0009 005 Phillip
Australia Ps0009 002 Westmead
Australia Ps0009 009 Woolloongabba
Belgium Ps0009 050 Bruxelles
Belgium Ps0009 052 Liège
Belgium Ps0009 051 Loverval
Canada Ps0009 673 Halifax
Canada Ps0009 652 Oakville
Canada Ps0009 651 Richmond Hill
Canada Ps0009 650 Surrey
Canada Ps0009 653 Toronto
Canada Ps0009 657 Waterloo
Germany Ps0009 218 Bonn
Germany Ps0009 209 Darmstadt
Germany Ps0009 214 Erlangen
Germany Ps0009 208 Frankfurt/Main
Germany Ps0009 210 Friedrichshafen
Germany Ps0009 211 Hamburg
Germany Ps0009 212 Heidelberg
Germany Ps0009 213 Mahlow
Germany Ps0009 205 Osnabrück
Germany Ps0009 217 Schweinfurt
Hungary Ps0009 254 Budapest
Hungary Ps0009 255 Budapest
Hungary Ps0009 253 Orosháza
Hungary Ps0009 259 Szekszárd
Italy Ps0009 300 Roma
Italy Ps0009 303 Roma
Japan Ps0009 629 Asahikawa
Japan Ps0009 605 Bunkyo-Ku
Japan Ps0009 607 Chiyoda
Japan Ps0009 610 Chuo Ku
Japan Ps0009 601 Fukuoka
Japan Ps0009 619 Gifu
Japan Ps0009 620 Hamamatsu
Japan Ps0009 608 Itabashi-Ku
Japan Ps0009 627 Itabashi-Ku
Japan Ps0009 609 Kobe
Japan Ps0009 600 Kurume
Japan Ps0009 622 Matsumoto
Japan Ps0009 604 Minato-Ku
Japan Ps0009 623 Morioka
Japan Ps0009 621 Nagoya
Japan Ps0009 625 Nankoku
Japan Ps0009 624 Obihiro
Japan Ps0009 611 Osaka
Japan Ps0009 614 Osaka
Japan Ps0009 603 Sapporo
Japan Ps0009 617 Sendai
Japan Ps0009 613 Shimotsuke
Japan Ps0009 602 Shinagawa-Ku
Japan Ps0009 612 Shinjuku-Ku
Japan Ps0009 618 Shinjuku-Ku
Japan Ps0009 626 Shinjuku-Ku
Japan Ps0009 628 Shinjuku-Ku
Japan Ps0009 615 Sumida
Japan Ps0009 606 Takaoka
Japan Ps0009 616 Tsu
Poland Ps0009 362 Bialystok
Poland Ps0009 369 Bialystok
Poland Ps0009 371 Bydgoszcz
Poland Ps0009 358 Katowice
Poland Ps0009 357 Kielce
Poland Ps0009 372 Lódz
Poland Ps0009 374 Poznan
Poland Ps0009 350 Warsaw
Poland Ps0009 351 Warsaw
Poland Ps0009 367 Wroclaw
Poland Ps0009 370 Wroclaw
Russian Federation Ps0009 400 Moscow
Russian Federation Ps0009 402 Moscow
Russian Federation Ps0009 403 Moscow
Russian Federation Ps0009 404 Saint Petersburg
United Kingdom Ps0009 556 Cardiff
United Kingdom Ps0009 551 Dundee
United Kingdom Ps0009 553 Edgbaston
United Kingdom Ps0009 552 Liverpool
United Kingdom Ps0009 550 Manchester
United Kingdom Ps0009 555 Salford
United States Ps0009 923 Albuquerque New Mexico
United States Ps0009 941 Alpharetta Georgia
United States Ps0009 910 Bakersfield California
United States Ps0009 922 Baton Rouge Louisiana
United States Ps0009 906 Boca Raton Florida
United States Ps0009 909 Boynton Beach Florida
United States Ps0009 912 Coral Gables Florida
United States Ps0009 908 East Windsor New Jersey
United States Ps0009 924 Houston Texas
United States Ps0009 907 Miami Florida
United States Ps0009 913 New York New York
United States Ps0009 903 Ocala Florida
United States Ps0009 958 Omaha Nebraska
United States Ps0009 921 Ormond Beach Florida
United States Ps0009 905 Overland Park Kansas
United States Ps0009 946 Phoenix Arizona
United States Ps0009 911 Plainfield Indiana
United States Ps0009 920 Portland Oregon
United States Ps0009 901 Portsmouth New Hampshire
United States Ps0009 915 Saint Louis Missouri
United States Ps0009 914 San Antonio Texas
United States Ps0009 919 San Diego California
United States Ps0009 918 Tampa Florida
United States Ps0009 917 Troy Michigan
United States Ps0009 900 West Des Moines Iowa

Sponsors (1)

Lead Sponsor Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Germany,  Hungary,  Italy,  Japan,  Poland,  Russian Federation,  United Kingdom, 

References & Publications (3)

Asahina A, Okubo Y, Morita A, Tada Y, Igarashi A, Langley RG, Deherder D, Matano M, Vanvoorden V, Wang M, Ohtsuki M, Nakagawa H. Bimekizumab Efficacy and Safety in Japanese Patients with Plaque Psoriasis in BE VIVID: A Phase 3, Ustekinumab and Placebo-Con — View Citation

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

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 the PASI score from Baseline. This is a scoring system that 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). 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 16
Primary Percentage of Participants With an Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 16 The Investigator's Global Assessment (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 PASI100 Response at Week 16 The PASI100 response assessments are based on a 100% improvement in the PASI score from Baseline. This is a scoring system that 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). 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 16
Secondary Percentage of Participants With an IGA 0 Response at Week 16 The Investigator's Global Assessment (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 16. Week 16
Secondary Percentage of Participants With a PASI75 Response at Week 4 The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that 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). 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 4
Secondary Percentage of Participants With a Patient Symptom Diary Response for Pain at Week 16 As Patient-Reported-Outcome (PRO) measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to the participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit.
PSD pain item was assessed daily on a numeric rating scale (NRS) from 0 (no pain) to 10 (very severe pain). PSD score for pain at a given visit was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in pain score higher than the prespecified 1.98 response threshold at Week 16. The endpoint was characterized as percentage of participants with PSD pain response.
Week 16
Secondary Percentage of Participants With a Patient Symptom Diary Response for Itch at Week 16 A PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit.
PSD itch item was assessed daily on a NRS from 0 (no itch) to 10 (very severe itch). PSD score for itch was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in itch score higher than the prespecified 2.39 response threshold at Week 16. The endpoint was characterized as percentage of participants with a PSD itch response.
Week 16
Secondary Percentage of Participants With a Patient Symptom Diary Response for Scaling at Week 16 As PRO measure, the PSD (further published as P-SIM) was used to assess key symptoms relevant to patients with moderate to severe plaque psoriasis. Site staff trained participants on the use of the electronic device used to collect ePRO diary data at Screening, device was then dispensed to the participant for home use until Week 16 Visit. The ePRO diary was completed on daily basis from Screening to Week 16 Visit. PSD scaling item was assessed daily on a NRS from 0 (no scaling) to 10 (very severe scaling). PSD score for scaling was an average of daily values over the week prior to the visit. The response was defined as an improvement (decrease) in scaling score higher than the prespecified 2.86 response threshold at Week 16. The endpoint was characterized as percentage of participants with a PSD scaling response. Week 16
Secondary Percentage of Participants With a Scalp IGA Response (Clear or Almost Clear) at Week 16 for Participants With Scalp Psoriasis (PSO) >=2 at Baseline Only participants with scalp involvement at Baseline completed the scalp IGA. Participants with scalp involvement at Baseline were defined as those with a scalp IGA score >0 at Baseline. Scalp lesions were assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe). Scalp IGA 0/1 response at Week 16 was defined as clear (0) or almost clear (1) with at least a 2-category improvement from Baseline to Week 16. Week 16
Secondary Percentage of Participants With a PASI90 Response at Week 12 The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that 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). 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 12
Secondary Percentage of Participants With a PASI90 Response at Week 52 The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that 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). 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 52
Secondary Percentage of Participants With an IGA (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 12 The Investigator's Global Assessment (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 12. Week 12
Secondary Percentage of Participants With an IGA (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 52 The Investigator's Global Assessment (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 52. Week 52
Secondary Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period 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 Adverse Event (AE) being considered. If a participant had no events, the total time at risk was used. From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)
Secondary Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period 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 end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)
Secondary Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period 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 end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)
Secondary Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period 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 Adverse Event (AE) being considered. If a participant had no events, the total time at risk was used. From Week 16 to Safety Follow-Up (up to 52 weeks duration)
Secondary Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period 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 Week 16 to Safety Follow-Up (up to 52 weeks duration)
Secondary Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period 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 Week 16 to Safety Follow-Up (up to 52 weeks duration)
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