Clinical trial NCT03010527: A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Patients With Chronic Plaque Psoriasis
Official title: A Multicenter, 48-Week, Double-Blind, Placebo-Controlled, Parallel-Group Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Plaque Psoriasis
Keywords: Chronic plaque psoriasis
Psoriasis
Bimekizumab
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2017-01-05
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter extension study to assess the long-term safety, tolerability and efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis


Eligibility criteria: Inclusion Criteria:

* Subject has provided informed consent
* Subject completes all dosing requirements in feeder study and completes PS0010 study without meeting any withdrawal criteria
* Female subjects of childbearing potential and male subjects with a partner of childbearing potential must continue to use an acceptable method of contraception (as detailed in PS0010) for up to 20 weeks after the last dose of study treatment in PS0011

Exclusion Criteria:

* Subject has previously participated in this study.
* Female subjects who plan to become pregnant during the study or within 20 weeks following last dose of study medication. Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose
* Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study.
* Subject must have a negative interferon gamma release assay (IGRA) as measured at Week 8 of PS0010

Primary outcomes:
measure: Incidence of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Treatment
timeFrame: From Baseline until Safety Follow-Up Visit (up to Week 64)
Secondary outcomes:
measure: Percentage of Participants With Psoriasis Area Severity Index (PASI90) Response Over Time
timeFrame: From Baseline during the Treatment Period (up to Week 48)
measure: Percentage of Participants With Investigator´s Global Assessment Response (Clear or Almost Clear With at Least a 2 Category Improvement From Baseline on a 5-point Scale) Over Time
timeFrame: From Baseline during the Treatment Period (up to Week 48)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ps0011 708
state: California
city: Washington
country: United States
facility: Ps0011 706
state: District of Columbia
city: West Des Moines
country: United States
facility: Ps0011 704
state: Iowa
city: Wilmington
country: United States
facility: Ps0011 738
state: North Carolina
city: Portland
country: United States
facility: Ps0011 712
state: Oregon
city: Dallas
country: United States
facility: Ps0011 733
state: Texas
city: Houston
country: United States
facility: Ps0011 709
state: Texas
city: Houston
country: United States
facility: Ps0011 702
state: Texas
city: Edmonton
country: Canada
facility: Ps0011 209
city: North Bay
country: Canada
facility: Ps0011 201
city: Peterborough
country: Canada
facility: Ps0011 206
city: Quebec City
country: Canada
facility: Ps0011 214
city: Surrey
country: Canada
facility: Ps0011 203
city: Waterloo
country: Canada
facility: Ps0011 205
city: Ostrava
country: Czechia
facility: Ps0011 300
city: Pardubice
country: Czechia
facility: Ps0011 303
city: Praha 10
country: Czechia
facility: Ps0011 301
city: Praha
country: Czechia
facility: Ps0011 304
city: Kecskemet
country: Hungary
facility: Ps0011 404
city: Oroshaza
country: Hungary
facility: Ps0011 400
city: Szekszard
country: Hungary
facility: Ps0011 405
city: Chiyoda-ku
country: Japan
facility: Ps0011 504
city: Minatoku
country: Japan
facility: Ps0011 503
city: Nagoya
country: Japan
facility: Ps0011 502
city: Shinagawa-ku
country: Japan
facility: Ps0011 501
city: Bialystok
country: Poland
facility: Ps0011 600
city: Bialystok
country: Poland
facility: Ps0011 603
city: Bialystok
country: Poland
facility: Ps0011 611
city: Gdynia
country: Poland
facility: Ps0011 610
city: Kielce
country: Poland
facility: Ps0011 604
city: Krakow
country: Poland
facility: Ps0011 608
city: Lublin
country: Poland
facility: Ps0011 605
city: Lublin
country: Poland
facility: Ps0011 606
city: Warszawa
country: Poland
facility: Ps0011 607
city: Wroclaw
country: Poland
facility: Ps0011 601
city: Wroclaw
country: Poland
facility: Ps0011 609
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: Blauvelt A, Papp KA, Merola JF, Gottlieb AB, Cross N, Madden C, Wang M, Cioffi C, Griffiths CEM. Bimekizumab for patients with moderate to severe plaque psoriasis: 60-week results from BE ABLE 2, a randomized, double-blinded, placebo-controlled, phase 2b extension study. J Am Acad Dermatol. 2020 Nov;83(5):1367-1374. doi: 10.1016/j.jaad.2020.05.105. Epub 2020 May 29.
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.