Clinical trial NCT03410992: A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Official title: A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study With an Initial Treatment Period Followed by a Randomized-Withdrawal 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 Chronic Plaque Psoriasis
Psoriatic Arthritis
Keywords: Bimekizumab
PSO
Psoriasis
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2018-01-25
Enrollment: 435
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: Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.


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, 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 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: At Week 16
measure: Percentage of Participants With an Investigator's Global Assessment (IGA) Response at Week 16
timeFrame: At Week 16
Secondary outcomes:
measure: Percentage of Participants With a PASI100 Response at Week 16
timeFrame: At Week 16
measure: Percentage of Participants With a IGA Clear Response at Week 16
timeFrame: At Week 16
measure: Percentage of Participants With a PASI75 Response at Week 4
timeFrame: At Week 4
measure: Percentage of Participants With a Patient Symptom Diary Response for Pain at Week 16
timeFrame: At Week 16
measure: Percentage of Participants With a Patient Symptom Diary Response for Itch at Week 16
timeFrame: At Week 16
measure: Percentage of Participants With a Patient Symptom Diary Response for Scaling at Week 16
timeFrame: At Week 16
measure: Percentage of Participants With Scalp IGA Response (Clear or Almost Clear) at Week 16 for Participants With Scalp Psoriasis (PSO) at Baseline
timeFrame: At Week 16
measure: Percentage of Participants With a PASI90 Response at Week 56 Among Week 16 PASI90 Responders
timeFrame: At Week 56
measure: Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period
timeFrame: From Baseline to end of Initial Treatment Period (up to Week 16)
measure: Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period
timeFrame: From Baseline to end of Initial Treatment Period (up to Week 16)
measure: Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Initial Treatment Period
timeFrame: From Baseline to end of Initial Treatment Period (up to Week 16)
measure: Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period
timeFrame: From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)
measure: Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period
timeFrame: From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)
measure: Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Randomized-Withdrawal Period
timeFrame: From end of Initial Treatment Period (Week 16) until the Safety Follow-Up (up to 56 weeks duration)
measure: Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment
timeFrame: From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)
measure: Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment
timeFrame: From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)
measure: Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to Study Treatment During the Escape Treatment
timeFrame: From Escape Baseline (Week 0) until Safety Follow-Up (up to 28 weeks duration)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Ps0013 919
state: California
city: San Diego
country: United States
facility: Ps0013 955
state: California
city: Santa Monica
country: United States
facility: Ps0013 967
state: California
city: Fort Myers
country: United States
facility: Ps0013 928
state: Florida
city: Sandy Springs
country: United States
facility: Ps0013 966
state: Georgia
city: Skokie
country: United States
facility: Ps0013 954
state: Illinois
city: Owensboro
country: United States
facility: Ps0013 962
state: Kentucky
city: New Orleans
country: United States
facility: Ps0013 944
state: Louisiana
city: Beverly
country: United States
facility: Ps0013 940
state: Massachusetts
city: Portsmouth
country: United States
facility: Ps0013 901
state: New Hampshire
city: Verona
country: United States
facility: Ps0013 956
state: New Jersey
city: Buffalo
country: United States
facility: Ps0013 947
state: New York
city: New York
country: United States
facility: Ps0013 968
state: New York
city: New York
country: United States
facility: Ps0013 965
state: New York
city: Rochester
country: United States
facility: Ps0013 963
state: New York
city: Cleveland
country: United States
facility: Ps0013 949
state: Ohio
city: Portland
country: United States
facility: Ps0013 929
state: Oregon
city: Johnston
country: United States
facility: Ps0013 937
state: Rhode Island
city: San Antonio
country: United States
facility: Ps0013 914
state: Texas
city: Murray
country: United States
facility: Ps0013 933
state: Utah
city: Carlton
country: Australia
facility: Ps0013 003
city: East Melbourne
country: Australia
facility: Ps0013 008
city: Kogarah
country: Australia
facility: Ps0013 006
city: Ajax
country: Canada
facility: Ps0013 658
city: Edmonton
country: Canada
facility: Ps0013 672
city: Hamilton
country: Canada
facility: Ps0013 671
city: Markham
country: Canada
facility: Ps0013 675
city: Mississauga
country: Canada
facility: Ps0013 663
city: Montréal
country: Canada
facility: Ps0013 660
city: North Bay
country: Canada
facility: Ps0013 668
city: Ottawa
country: Canada
facility: Ps0013 667
city: Québec
country: Canada
facility: Ps0013 665
city: Surrey
country: Canada
facility: Ps0013 676
city: Waterloo
country: Canada
facility: Ps0013 657
city: Hamburg
country: Germany
facility: Ps0013 202
city: Hamburg
country: Germany
facility: Ps0013 220
city: Münster
country: Germany
facility: Ps0013 219
city: Schwerin
country: Germany
facility: Ps0013 200
city: Witten
country: Germany
facility: Ps0013 204
city: Budapest
country: Hungary
facility: Ps0013 261
city: Miskolc
country: Hungary
facility: Ps0013 262
city: Orosháza
country: Hungary
facility: Ps0013 253
city: Szeged
country: Hungary
facility: Ps0013 260
city: Szolnok
country: Hungary
facility: Ps0013 250
city: Veszprém
country: Hungary
facility: Ps0013 258
city: Busan
country: Korea, Republic of
facility: Ps0013 701
city: Seongnam-si
country: Korea, Republic of
facility: Ps0013 705
city: Seoul
country: Korea, Republic of
facility: Ps0013 703
city: Białystok
country: Poland
facility: Ps0013 355
city: Białystok
country: Poland
facility: Ps0013 361
city: Białystok
country: Poland
facility: Ps0013 369
city: Gdańsk
country: Poland
facility: Ps0013 352
city: Katowice
country: Poland
facility: Ps0013 358
city: Katowice
country: Poland
facility: Ps0013 359
city: Katowice
country: Poland
facility: Ps0013 366
city: Kielce
country: Poland
facility: Ps0013 357
city: Kraków
country: Poland
facility: Ps0013 363
city: Lublin
country: Poland
facility: Ps0013 356
city: Poznań
country: Poland
facility: Ps0013 374
city: Szczecin
country: Poland
facility: Ps0013 353
city: Warsaw
country: Poland
facility: Ps0013 350
city: Warsaw
country: Poland
facility: Ps0013 351
city: Warszawa
country: Poland
facility: Ps0013 354
city: Wrocław
country: Poland
facility: Ps0013 365
city: Wrocław
country: Poland
facility: Ps0013 368
city: Wrocław
country: Poland
facility: Ps0013 370
city: Łódź
country: Poland
facility: Ps0013 360
city: Moscow
country: Russian Federation
facility: Ps0013 400
city: Moscow
country: Russian Federation
facility: Ps0013 402
city: Moscow
country: Russian Federation
facility: Ps0013 403
city: Saint Petersburg
country: Russian Federation
facility: Ps0013 404
city: Saint Petersburg
country: Russian Federation
facility: Ps0013 405
city: Saratov
country: Russian Federation
facility: Ps0013 401
city: Yaroslavl
country: Russian Federation
facility: Ps0013 406
city: Manchester
country: United Kingdom
facility: Ps0013 550
city: Reading
country: United Kingdom
facility: Ps0013 554
city: Salford
country: United Kingdom
facility: Ps0013 555
Study officials:
affiliation: 001 844 599 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: 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: Gordon KB, Foley P, Krueger JG, Pinter A, Reich K, Vender R, Vanvoorden V, Madden C, White K, Cioffi C, Blauvelt A. Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021 Feb 6;397(10273):475-486. doi: 10.1016/S0140-6736(21)00126-4.