A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Patients With Chronic Plaque Psoriasis
NCT ID: NCT03010527
Last Updated: 2022-10-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
217 participants
INTERVENTIONAL
2016-12-14
2018-09-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Subjects with a PASI90 response at Week 12 and receiving Placebo in PS0010 entering PS0011 will receive Placebo.
Placebo
Subjects will receive Placebo injections every four weeks (Q4W)
Bimekizumab dosing regimen 1
Subjects with a PASI90 response at Week 12 receiving dosing regimen 1 in PS0010 entering PS0011 will receive the same dosing regimen.
Subjects who do not achieve PASI90 response at Week 12 receiving dosing regimen 1 in PS0010 will be assigned to a higher dosing regimen.
Bimekizumab
Subjects will receive bimekizumab injections every four weeks (Q4W)
Bimekizumab dosing regimen 2
Subjects with a PASI90 response at Week 12 receiving dosing regimen 2 in PS0010 entering PS0011 will receive the same dosing regimen.
Subjects who do not achieve PASI90 response at Week 12 receiving dosing regimen 2 in PS0010 will be assigned to a higher dosing regimen.
Bimekizumab
Subjects will receive bimekizumab injections every four weeks (Q4W)
Bimekizumab dosing regimen 3
Subjects that were initially randomized to bimekizumab dosage regimen 3, 4 and 5 in PS0010 will receive bimekizumab dosing regimen 3.
Bimekizumab
Subjects will receive bimekizumab injections every four weeks (Q4W)
Interventions
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Bimekizumab
Subjects will receive bimekizumab injections every four weeks (Q4W)
Placebo
Subjects will receive Placebo injections every four weeks (Q4W)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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UCB Biopharma SRL
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273 (UCB)
Locations
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Ps0011 708
Los Angeles, California, United States
Ps0011 706
Washington D.C., District of Columbia, United States
Ps0011 704
West Des Moines, Iowa, United States
Ps0011 738
Wilmington, North Carolina, United States
Ps0011 712
Portland, Oregon, United States
Ps0011 733
Dallas, Texas, United States
Ps0011 709
Houston, Texas, United States
Ps0011 702
Houston, Texas, United States
Ps0011 209
Edmonton, , Canada
Ps0011 201
North Bay, , Canada
Ps0011 206
Peterborough, , Canada
Ps0011 214
Québec, , Canada
Ps0011 203
Surrey, , Canada
Ps0011 205
Waterloo, , Canada
Ps0011 300
Ostrava, , Czechia
Ps0011 303
Pardubice, , Czechia
Ps0011 301
Prague, , Czechia
Ps0011 304
Prague, , Czechia
Ps0011 404
Kecskemét, , Hungary
Ps0011 400
Orosháza, , Hungary
Ps0011 405
Szekszárd, , Hungary
Ps0011 504
Chiyoda-ku, , Japan
Ps0011 503
Minatoku, , Japan
Ps0011 502
Nagoya, , Japan
Ps0011 501
Shinagawa-ku, , Japan
Ps0011 600
Bialystok, , Poland
Ps0011 603
Bialystok, , Poland
Ps0011 611
Bialystok, , Poland
Ps0011 610
Gdynia, , Poland
Ps0011 604
Kielce, , Poland
Ps0011 608
Krakow, , Poland
Ps0011 605
Lublin, , Poland
Ps0011 606
Lublin, , Poland
Ps0011 607
Warsaw, , Poland
Ps0011 601
Wroclaw, , Poland
Ps0011 609
Wroclaw, , Poland
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Product Information
FDA Safety Alerts and Recalls
Other Identifiers
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2016-001892-57
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PS0011
Identifier Type: -
Identifier Source: org_study_id
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