Clinical trial NCT03536884: A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Official title: A Multicenter, Randomized, Double-Blind, Secukinumab-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
Keywords: Bimekizumab
PSO
Psoriasis
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2018-05-25
Enrollment: 743
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 secukinumab in subjects with moderate to severe chronic plaque psoriasis (PSO).

Detailed description: The study consists of a 48-week double-blind Treatment Period, an optional 96-week open-label extension (OLE) Period and an optional 48-week OLE2 Period for eligible subjects in the USA and Canada.

Eligibility criteria: Inclusion Criteria:

Double-blind Treatment Period

* Male or female at least 18 years of age
* Subject must have had chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening visit
* Subject must have 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 must be a candidate for systemic PSO therapy and/or phototherapy
* Subject must be considered, in the opinion of the Investigator, to be a suitable candidate for treatment with secukinumab per regional labeling and has no contraindications to receive secukinumab as per the local label
* Female subject of childbearing potential must be willing to use highly effective method of contraception

Open-label extension (OLE) Period

* Completed the double-blind Treatment Period without meeting any withdrawal criteria
* All Week 48 visit assessments completed
* Compliant with ongoing clinical study requirements
* Signed a separate OLE Period Informed Consent Form (ICF)
* Female subject of childbearing potential must be willing to use highly effective method of contraception

OLE2 Period (USA and Canada)

* Completed the OLE Period without meeting any withdrawal criteria
* Compliant with ongoing clinical study requirements
* Female subject of childbearing potential must be willing to use highly effective method of contraception
* Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long as they have no active symptomatic disease (US only)
* Signed a separate OLE2 Period ICF

Exclusion Criteria:

Double-blind Treatment Period

* Subject has an active infection (except common cold), a serious infection, or a history of opportunistic, recurrent or 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 severe 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

OLE2 Period (USA and Canada)

* Subject has developed any medical or psychiatric condition, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in OLE2 Period
* Subject had a positive or indeterminate interferon-gamma release assay (IGRA) in the OLE study to Week 144, unless appropriately evaluated and treated
* Presence of active suicidal ideation or severe depression
* Subject has developed any active malignancy or history of malignancy prior to the OLE2 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 100 (PASI100) Response at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants With a PASI75 Response at Week 4
timeFrame: Week 4
measure: Percentage of Participants With a PASI90 Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants With a PASI100 Response at Week 48
timeFrame: Week 48
measure: Percentage of Participants With a Investigator´s Global Assessment (IGA) Response (0/1) at Week 16
timeFrame: Week 16
measure: Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Investigational Medicinal Product (IMP) From Baseline up to Week 225
timeFrame: From Baseline up to Week 225
measure: Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225
timeFrame: From Baseline up to Week 225
measure: Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 225
timeFrame: From Baseline up to Week 225
Other outcomes:
Locations:
city: Santa Ana
country: United States
facility: Ps0015 975
state: California
city: Danbury
country: United States
facility: Ps0015 939
state: Connecticut
city: Ocala
country: United States
facility: Ps0015 903
state: Florida
city: Ormond Beach
country: United States
facility: Ps0015 921
state: Florida
city: Pembroke Pines
country: United States
facility: Ps0015 977
state: Florida
city: Tampa
country: United States
facility: Ps0015 936
state: Florida
city: Tampa
country: United States
facility: Ps0015 976
state: Florida
city: West Palm Beach
country: United States
facility: Ps0015 970
state: Florida
city: Sandy Springs
country: United States
facility: Ps0015 966
state: Georgia
city: Skokie
country: United States
facility: Ps0015 954
state: Illinois
city: West Dundee
country: United States
facility: Ps0015 972
state: Illinois
city: West Des Moines
country: United States
facility: Ps0015 900
state: Iowa
city: New Orleans
country: United States
facility: Ps0015 944
state: Louisiana
city: Clayton
country: United States
facility: Ps0015 915
state: Missouri
city: Saint Louis
country: United States
facility: Ps0015 953
state: Missouri
city: Portsmouth
country: United States
facility: Ps0015 901
state: New Hampshire
city: Kew Gardens
country: United States
facility: Ps0015 965
state: New York
city: High Point
country: United States
facility: Ps0015 969
state: North Carolina
city: Wilmington
country: United States
facility: Ps0015 971
state: North Carolina
city: Bexley
country: United States
facility: Ps0015 980
state: Ohio
city: Portland
country: United States
facility: Ps0015 920
state: Oregon
city: Portland
country: United States
facility: Ps0015 929
state: Oregon
city: Dallas
country: United States
facility: Ps0015 979
state: Texas
city: Houston
country: United States
facility: Ps0015 924
state: Texas
city: Pflugerville
country: United States
facility: Ps0015 978
state: Texas
city: Carlton
country: Australia
facility: PS0015 3
city: Hectorville
country: Australia
facility: PS0015 7
city: Kogarah
country: Australia
facility: PS0015 6
city: Parkville
country: Australia
facility: Ps0015 11
city: Woolloongabba
country: Australia
facility: PS0015 9
city: Brussels
country: Belgium
facility: Ps0015 54
city: Bruxelles
country: Belgium
facility: Ps0015 50
city: Liege
country: Belgium
facility: Ps0015 52
city: Halifax
country: Canada
facility: Ps0015 673
city: Hamilton
country: Canada
facility: Ps0015 671
city: Mississauga
country: Canada
facility: Ps0015 663
city: Peterborough
country: Canada
facility: Ps0015 661
city: Richmond Hill
country: Canada
facility: Ps0015 678
city: Toronto
country: Canada
facility: Ps0015 677
city: Waterloo
country: Canada
facility: Ps0015 657
city: Toulouse
country: France
facility: Ps0015 153
city: Augsburg
country: Germany
facility: Ps0015 223
city: Berlin
country: Germany
facility: Ps0015 237
city: Hamburg
country: Germany
facility: Ps0015 211
city: Lübeck
country: Germany
facility: Ps0015 215
city: Mahlow
country: Germany
facility: Ps0015 213
city: Mainz
country: Germany
facility: Ps0015 238
city: München
country: Germany
facility: Ps0015 234
city: Münster
country: Germany
facility: Ps0015 219
city: Neu-ulm
country: Germany
facility: Ps0015 236
city: Tuebingen
country: Germany
facility: Ps0015 222
city: Witten
country: Germany
facility: Ps0015 204
city: Amsterdam
country: Netherlands
facility: Ps0015 265
city: Breda
country: Netherlands
facility: Ps0015 263
city: Bialystok
country: Poland
facility: Ps0015 355
city: Bialystok
country: Poland
facility: Ps0015 361
city: Bialystok
country: Poland
facility: Ps0015 369
city: Gdansk
country: Poland
facility: Ps0015 352
city: Katowice
country: Poland
facility: Ps0015 366
city: Katowice
country: Poland
facility: Ps0015 378
city: Krakow
country: Poland
facility: Ps0015 376
city: Krakow
country: Poland
facility: Ps0015 379
city: Lodz
country: Poland
facility: Ps0015 372
city: Ostrowiec Swietokrzyski
country: Poland
facility: Ps0015 377
city: Wroclaw
country: Poland
facility: Ps0015 368
city: Wroclaw
country: Poland
facility: Ps0015 375
city: Alicante
country: Spain
facility: Ps0015 455
city: Barcelona
country: Spain
facility: Ps0015 450
city: Madrid
country: Spain
facility: Ps0015 451
city: Madrid
country: Spain
facility: Ps0015 454
city: Madrid
country: Spain
facility: Ps0015 456
city: Sant Joan Despí
country: Spain
facility: Ps0015 457
city: Gaziantep
country: Turkey
facility: Ps0015 763
city: Istanbul
country: Turkey
facility: Ps0015 762
city: Kayseri
country: Turkey
facility: Ps0015 760
city: Newcastle Upon Tyne
country: United Kingdom
facility: Ps0015 559
city: Salford
country: United Kingdom
facility: Ps0015 555
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: Strober B, Paul C, Blauvelt A, Thaci D, Puig L, Lebwohl M, White K, Vanvoorden V, Deherder D, Gomez NN, Eyerich K. Bimekizumab efficacy and safety in patients with moderate to severe plaque psoriasis: Two-year interim results from the open-label extension of the randomized BE RADIANT phase 3b trial. J Am Acad Dermatol. 2023 Sep;89(3):486-495. doi: 10.1016/j.jaad.2023.04.063. Epub 2023 May 12.
citation: Lebwohl M, Merola JF, Strober B, Armstrong A, Yoshizaki A, Gisondi P, Szilagyi B, Peterson L, de Cuyper D, Cross N, Davies O, Gottlieb AB. Bimekizumab safety in moderate to severe plaque psoriasis: Rates of hepatic events and changes in liver parameters over 2 years in randomized phase 3/3b trials. J Am Acad Dermatol. 2024 Aug;91(2):281-289. doi: 10.1016/j.jaad.2024.03.041. Epub 2024 Apr 6.
citation: Merola JF, Gottlieb AB, Pinter A, Elewski B, Gooderham M, Warren RB, Piaserico S, Wixted K, Cross N, Tilt N, Wiegratz S, Mrowietz U. Bimekizumab Efficacy in High-Impact Areas: Pooled 2-Year Analysis in Scalp, Nail, and Palmoplantar Psoriasis from Phase 3/3b Randomized Controlled Trials. Dermatol Ther (Heidelb). 2024 Dec;14(12):3291-3306. doi: 10.1007/s13555-024-01295-w. Epub 2024 Nov 22.
citation: Gottlieb AB, Warren RB, Augustin M, 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 Reported Data from the BE RADIANT Phase 3b Trial. Adv Ther. 2021 Oct;38(10):5253-5269. doi: 10.1007/s12325-021-01836-1. Epub 2021 Sep 2.
citation: Yeremenko N. Out of the shadow of interleukin-17A: the role of interleukin-17F and other interleukin-17 family cytokines in spondyloarthritis. Curr Opin Rheumatol. 2021 Jul 1;33(4):333-340. doi: 10.1097/BOR.0000000000000805.
citation: Reich K, Warren RB, Lebwohl M, Gooderham M, Strober B, Langley RG, Paul C, De Cuyper D, Vanvoorden V, Madden C, Cioffi C, Peterson L, Blauvelt A. Bimekizumab versus Secukinumab in Plaque Psoriasis. N Engl J Med. 2021 Jul 8;385(2):142-152. doi: 10.1056/NEJMoa2102383. Epub 2021 Apr 23.