Clinical trial NCT03412747: A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Official title: A Phase 3, Multicenter, Randomized, Double-Blind Study With an Active-Controlled Initial Treatment Period Followed by a Dose-Blind Maintenance Treatment Period 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 Plaque Psoriasis
Keywords: Bimekizumab
PSO
Psoriasis
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2018-01-26
Enrollment: 478
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 adalimumab 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 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

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) Response (Clear or Almost Clear With at Least 2-Category Improvement Relative to Baseline) at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants With a PASI90 Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants With an IGA Response (Clear or Almost Clear With at Least 2-category Improvement Relative to Baseline) at Week 24
timeFrame: Week 24
measure: Percentage of Participants With a PASI75 Response at Week 4
timeFrame: Week 4
measure: Percentage of Participants With a PASI100 Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants With a PASI100 Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants With a PASI90 Response at Week 56
timeFrame: Week 56
measure: Percentage of Participants With an IGA Response (Clear or Almost Clear With at Least 2-category Improvement Relative to Baseline) at Week 56
timeFrame: Week 56
measure: Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24
timeFrame: From Baseline to Week 24
measure: Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24
timeFrame: From Baseline to Week 24
measure: Number of Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment From Baseline to Week 24
timeFrame: From Baseline to Week 24
measure: 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)
timeFrame: From Baseline to Safety Follow-Up Visit (up to Week 72)
measure: 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)
timeFrame: From Baseline to Safety Follow-Up Visit (up to Week 72)
measure: 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)
timeFrame: From Baseline to Safety Follow-Up Visit (up to Week 72)
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Ps0008 957
state: Arizona
city: Los Angeles
country: United States
facility: Ps0008 927
state: California
city: San Diego
country: United States
facility: Ps0008 955
state: California
city: San Luis Obispo
country: United States
facility: Ps0008 943
state: California
city: Santa Monica
country: United States
facility: Ps0008 967
state: California
city: Danbury
country: United States
facility: Ps0008 939
state: Connecticut
city: Washington
country: United States
facility: Ps0008 934
state: District of Columbia
city: Boca Raton
country: United States
facility: Ps0008 906
state: Florida
city: Tampa
country: United States
facility: Ps0008 936
state: Florida
city: West Des Moines
country: United States
facility: Ps0008 900
state: Iowa
city: Overland Park
country: United States
facility: Ps0008 905
state: Kansas
city: Beverly
country: United States
facility: Ps0008 940
state: Massachusetts
city: Brighton
country: United States
facility: Ps0008 925
state: Massachusetts
city: Troy
country: United States
facility: Ps0008 917
state: Michigan
city: East Windsor
country: United States
facility: Ps0008 908
state: New Jersey
city: Rocky Mount
country: United States
facility: Ps0008 961
state: North Carolina
city: Winston-Salem
country: United States
facility: Ps0008 935
state: North Carolina
city: Oklahoma City
country: United States
facility: Ps0008 932
state: Oklahoma
city: Portland
country: United States
facility: Ps0008 929
state: Oregon
city: Greer
country: United States
facility: Ps0008 945
state: South Carolina
city: Dallas
country: United States
facility: Ps0008 931
state: Texas
city: Houston
country: United States
facility: Ps0008 924
state: Texas
city: Houston
country: United States
facility: Ps0008 951
state: Texas
city: East Melbourne
country: Australia
facility: Ps0008 008
city: Fremantle
country: Australia
facility: Ps0008 004
city: Hectorville
country: Australia
facility: Ps0008 007
city: Kogarah
country: Australia
facility: Ps0008 010
city: Phillip
country: Australia
facility: Ps0008 005
city: Woolloongabba
country: Australia
facility: Ps0008 009
city: Calgary
country: Canada
facility: Ps0008 659
city: Mississauga
country: Canada
facility: Ps0008 663
city: Montréal
country: Canada
facility: Ps0008 660
city: Peterborough
country: Canada
facility: Ps0008 661
city: Toronto
country: Canada
facility: Ps0008 662
city: Toronto
country: Canada
facility: Ps0008 664
city: Waterloo
country: Canada
facility: Ps0008 657
city: Windsor
country: Canada
facility: Ps0008 669
city: Windsor
country: Canada
facility: Ps0008 670
city: Winnipeg
country: Canada
facility: Ps0008 674
city: Berlin
country: Germany
facility: Ps0008 207
city: Bonn
country: Germany
facility: Ps0008 218
city: Dresden
country: Germany
facility: Ps0008 203
city: Hamburg
country: Germany
facility: Ps0008 211
city: Hamburg
country: Germany
facility: Ps0008 220
city: Lubeck
country: Germany
facility: Ps0008 215
city: Mahlow
country: Germany
facility: Ps0008 213
city: Osnabrück
country: Germany
facility: Ps0008 205
city: Schweinfurt
country: Germany
facility: Ps0008 217
city: Budapest
country: Hungary
facility: Ps0008 252
city: Budapest
country: Hungary
facility: Ps0008 254
city: Budapest
country: Hungary
facility: Ps0008 255
city: Debrecen
country: Hungary
facility: Ps0008 256
city: Gyula
country: Hungary
facility: Ps0008 251
city: Szeged
country: Hungary
facility: Ps0008 260
city: Gwangju
country: Korea, Republic of
facility: Ps0008 702
city: Seoul
country: Korea, Republic of
facility: Ps0008 700
city: Białystok
country: Poland
facility: Ps0008 355
city: Białystok
country: Poland
facility: Ps0008 362
city: Bydgoszcz
country: Poland
facility: Ps0008 371
city: Gdańsk
country: Poland
facility: Ps0008 352
city: Katowice
country: Poland
facility: Ps0008 359
city: Katowice
country: Poland
facility: Ps0008 366
city: Kraków
country: Poland
facility: Ps0008 363
city: Lublin
country: Poland
facility: Ps0008 356
city: Nowa Sól
country: Poland
facility: Ps0008 364
city: Szczecin
country: Poland
facility: Ps0008 353
city: Warszawa
country: Poland
facility: Ps0008 354
city: Wrocław
country: Poland
facility: Ps0008 365
city: Wrocław
country: Poland
facility: Ps0008 367
city: Wrocław
country: Poland
facility: Ps0008 373
city: Łódź
country: Poland
facility: Ps0008 360
city: Łódź
country: Poland
facility: Ps0008 372
city: Saint Petersburg
country: Russian Federation
facility: Ps0008 405
city: Saratov
country: Russian Federation
facility: Ps0008 401
city: Yaroslavl
country: Russian Federation
facility: Ps0008 406
city: Taipei
country: Taiwan
facility: Ps0008 754
city: Taipei
country: Taiwan
facility: Ps0008 755
Study officials:
affiliation: +1 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
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: 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 BE SURE randomized controlled trial and the open-label extension from the BE BRIGHT trial. Br J Dermatol. 2023 Jan 23;188(1):22-31. doi: 10.1093/bjd/ljac021.
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, Blauvelt A, Bagel J, Papp KA, Yamauchi P, Armstrong A, Langley RG, Vanvoorden V, De Cuyper D, Cioffi C, Peterson L, Cross N, Reich K. Bimekizumab versus Adalimumab in Plaque Psoriasis. N Engl J Med. 2021 Jul 8;385(2):130-141. doi: 10.1056/NEJMoa2102388. Epub 2021 Apr 23.