A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Psoriatic Arthritis Clinical Trial

— BE VIVID  

Official title:

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03370133
• Other study ID #: PS0009
• Secondary ID: 2016-003425-42
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Arthritis, Psoriatic
• Chronic Plaque Psoriasis
• Moderate to Severe Chronic Plaque Psoriasis
• Psoriasis
• Psoriatic Arthritis

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)