Clinical trial NCT03370133: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Plaque Psoriasis
Moderate to Severe Chronic Plaque Psoriasis
Psoriatic Arthritis
Keywords: Bimekizumab
PSO
Psoriasis
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2017-12-12
Enrollment: 567
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16
timeFrame: Week 16
measure: 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
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants With a PASI100 Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants With an IGA 0 Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants With a PASI75 Response at Week 4
timeFrame: Week 4
measure: Percentage of Participants With a Patient Symptom Diary Response for Pain at Week 16
timeFrame: Week 16
measure: Percentage of Participants With a Patient Symptom Diary Response for Itch at Week 16
timeFrame: Week 16
measure: Percentage of Participants With a Patient Symptom Diary Response for Scaling at Week 16
timeFrame: Week 16
measure: Percentage of Participants With a Scalp IGA Response (Clear or Almost Clear) at Week 16 for Participants With Scalp Psoriasis (PSO) >=2 at Baseline
timeFrame: Week 16
measure: Percentage of Participants With a PASI90 Response at Week 12
timeFrame: Week 12
measure: Percentage of Participants With a PASI90 Response at Week 52
timeFrame: Week 52
measure: Percentage of Participants With an IGA (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 12
timeFrame: Week 12
measure: Percentage of Participants With an IGA (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 52
timeFrame: Week 52
measure: Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period
timeFrame: From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)
measure: Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period
timeFrame: From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)
measure: Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to Study Treatment During the Initial Treatment Period
timeFrame: From Baseline to end of Initial Treatment Period, including the Safety Follow-Up visit for those withdrawn from IMP (up to 36 weeks)
measure: Number of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period
timeFrame: From Week 16 to Safety Follow-Up (up to 52 weeks duration)
measure: Number of Serious Adverse Events (SAEs) Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period
timeFrame: From Week 16 to Safety Follow-Up (up to 52 weeks duration)
measure: Number of TEAEs Leading to Withdrawal Adjusted by Duration of Subject Exposure to Study Treatment During the Maintenance Treatment Period
timeFrame: From Week 16 to Safety Follow-Up (up to 52 weeks duration)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Ps0009 946
state: Arizona
city: Bakersfield
country: United States
facility: Ps0009 910
state: California
city: San Diego
country: United States
facility: Ps0009 919
state: California
city: Boca Raton
country: United States
facility: Ps0009 906
state: Florida
city: Boynton Beach
country: United States
facility: Ps0009 909
state: Florida
city: Coral Gables
country: United States
facility: Ps0009 912
state: Florida
city: Miami
country: United States
facility: Ps0009 907
state: Florida
city: Ocala
country: United States
facility: Ps0009 903
state: Florida
city: Ormond Beach
country: United States
facility: Ps0009 921
state: Florida
city: Tampa
country: United States
facility: Ps0009 918
state: Florida
city: Alpharetta
country: United States
facility: Ps0009 941
state: Georgia
city: Plainfield
country: United States
facility: Ps0009 911
state: Indiana
city: West Des Moines
country: United States
facility: Ps0009 900
state: Iowa
city: Overland Park
country: United States
facility: Ps0009 905
state: Kansas
city: Baton Rouge
country: United States
facility: Ps0009 922
state: Louisiana
city: Troy
country: United States
facility: Ps0009 917
state: Michigan
city: Saint Louis
country: United States
facility: Ps0009 915
state: Missouri
city: Omaha
country: United States
facility: Ps0009 958
state: Nebraska
city: Portsmouth
country: United States
facility: Ps0009 901
state: New Hampshire
city: East Windsor
country: United States
facility: Ps0009 908
state: New Jersey
city: Albuquerque
country: United States
facility: Ps0009 923
state: New Mexico
city: New York
country: United States
facility: Ps0009 913
state: New York
city: Portland
country: United States
facility: Ps0009 920
state: Oregon
city: Houston
country: United States
facility: Ps0009 924
state: Texas
city: San Antonio
country: United States
facility: Ps0009 914
state: Texas
city: Fremantle
country: Australia
facility: Ps0009 004
city: Phillip
country: Australia
facility: Ps0009 005
city: Westmead
country: Australia
facility: Ps0009 002
city: Woolloongabba
country: Australia
facility: Ps0009 009
city: Bruxelles
country: Belgium
facility: Ps0009 050
city: Liège
country: Belgium
facility: Ps0009 052
city: Loverval
country: Belgium
facility: Ps0009 051
city: Halifax
country: Canada
facility: Ps0009 673
city: Oakville
country: Canada
facility: Ps0009 652
city: Richmond Hill
country: Canada
facility: Ps0009 651
city: Surrey
country: Canada
facility: Ps0009 650
city: Toronto
country: Canada
facility: Ps0009 653
city: Waterloo
country: Canada
facility: Ps0009 657
city: Bonn
country: Germany
facility: Ps0009 218
city: Darmstadt
country: Germany
facility: Ps0009 209
city: Erlangen
country: Germany
facility: Ps0009 214
city: Frankfurt/Main
country: Germany
facility: Ps0009 208
city: Friedrichshafen
country: Germany
facility: Ps0009 210
city: Hamburg
country: Germany
facility: Ps0009 211
city: Heidelberg
country: Germany
facility: Ps0009 212
city: Mahlow
country: Germany
facility: Ps0009 213
city: Osnabrück
country: Germany
facility: Ps0009 205
city: Schweinfurt
country: Germany
facility: Ps0009 217
city: Budapest
country: Hungary
facility: Ps0009 254
city: Budapest
country: Hungary
facility: Ps0009 255
city: Orosháza
country: Hungary
facility: Ps0009 253
city: Szekszárd
country: Hungary
facility: Ps0009 259
city: Roma
country: Italy
facility: Ps0009 300
city: Roma
country: Italy
facility: Ps0009 303
city: Asahikawa
country: Japan
facility: Ps0009 629
city: Bunkyō-Ku
country: Japan
facility: Ps0009 605
city: Chiyoda
country: Japan
facility: Ps0009 607
city: Chuo Ku
country: Japan
facility: Ps0009 610
city: Fukuoka
country: Japan
facility: Ps0009 601
city: Gifu
country: Japan
facility: Ps0009 619
city: Hamamatsu
country: Japan
facility: Ps0009 620
city: Itabashi-Ku
country: Japan
facility: Ps0009 608
city: Itabashi-Ku
country: Japan
facility: Ps0009 627
city: Kobe
country: Japan
facility: Ps0009 609
city: Kurume
country: Japan
facility: Ps0009 600
city: Matsumoto
country: Japan
facility: Ps0009 622
city: Minato-Ku
country: Japan
facility: Ps0009 604
city: Morioka
country: Japan
facility: Ps0009 623
city: Nagoya
country: Japan
facility: Ps0009 621
city: Nankoku
country: Japan
facility: Ps0009 625
city: Obihiro
country: Japan
facility: Ps0009 624
city: Osaka
country: Japan
facility: Ps0009 611
city: Osaka
country: Japan
facility: Ps0009 614
city: Sapporo
country: Japan
facility: Ps0009 603
city: Sendai
country: Japan
facility: Ps0009 617
city: Shimotsuke
country: Japan
facility: Ps0009 613
city: Shinagawa-Ku
country: Japan
facility: Ps0009 602
city: Shinjuku-Ku
country: Japan
facility: Ps0009 612
city: Shinjuku-Ku
country: Japan
facility: Ps0009 618
city: Shinjuku-Ku
country: Japan
facility: Ps0009 626
city: Shinjuku-Ku
country: Japan
facility: Ps0009 628
city: Sumida
country: Japan
facility: Ps0009 615
city: Takaoka
country: Japan
facility: Ps0009 606
city: Tsu
country: Japan
facility: Ps0009 616
city: Białystok
country: Poland
facility: Ps0009 362
city: Białystok
country: Poland
facility: Ps0009 369
city: Bydgoszcz
country: Poland
facility: Ps0009 371
city: Katowice
country: Poland
facility: Ps0009 358
city: Kielce
country: Poland
facility: Ps0009 357
city: Poznań
country: Poland
facility: Ps0009 374
city: Warsaw
country: Poland
facility: Ps0009 350
city: Warsaw
country: Poland
facility: Ps0009 351
city: Wrocław
country: Poland
facility: Ps0009 367
city: Wrocław
country: Poland
facility: Ps0009 370
city: Łódź
country: Poland
facility: Ps0009 372
city: Moscow
country: Russian Federation
facility: Ps0009 400
city: Moscow
country: Russian Federation
facility: Ps0009 402
city: Moscow
country: Russian Federation
facility: Ps0009 403
city: Saint Petersburg
country: Russian Federation
facility: Ps0009 404
city: Cardiff
country: United Kingdom
facility: Ps0009 556
city: Dundee
country: United Kingdom
facility: Ps0009 551
city: Edgbaston
country: United Kingdom
facility: Ps0009 553
city: Liverpool
country: United Kingdom
facility: Ps0009 552
city: Manchester
country: United Kingdom
facility: Ps0009 550
city: Salford
country: United Kingdom
facility: Ps0009 555
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: 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-Controlled Study. Dermatol Ther (Heidelb). 2023 Mar;13(3):751-768. doi: 10.1007/s13555-022-00883-y. Epub 2023 Jan 17.
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 Trials. JAMA Dermatol. 2022 Jul 1;158(7):735-744. doi: 10.1001/jamadermatol.2022.1185.
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 3 years of treatment in randomized phase III trials. Br J Dermatol. 2024 Mar 15;190(4):477-485. doi: 10.1093/bjd/ljad429.
citation: Warren RB, Gottlieb AB, Merola JF, Garcia L, Cioffi C, Peterson L, Pelligra C, Ciaravino V. Psychometric Validation of the Psoriasis Symptoms and Impacts Measure (P-SIM), a Novel Patient-Reported Outcome Instrument for Patients with Plaque Psoriasis, Using Data from the BE VIVID and BE READY Phase 3 Trials. Dermatol Ther (Heidelb). 2021 Oct;11(5):1551-1569. doi: 10.1007/s13555-021-00570-4. Epub 2021 Jul 14.
citation: Reich K, Papp KA, Blauvelt A, Langley RG, Armstrong A, Warren RB, Gordon KB, Merola JF, Okubo Y, Madden C, Wang M, Cioffi C, Vanvoorden V, Lebwohl M. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial. Lancet. 2021 Feb 6;397(10273):487-498. doi: 10.1016/S0140-6736(21)00125-2.