A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Adult Patients With Chronic Plaque Psoriasis
NCT ID: NCT03230292
Last Updated: 2022-07-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
43 participants
INTERVENTIONAL
2017-07-03
2019-03-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1
Subjects in this cohort will receive dose 1 every four weeks (Q4W) subcutaneously (sc) during the 48-week open-label Treatment Period. There will be an option to increase the dose to dose 2 Q4W at the discretion of the Investigator if the subject's Psoriasis Area and Severity Index (PASI) response is \>=50% to \<75% reduction from the Baseline of PS0016 at Week 12 or later. If the subject's disease is adequately controlled on dose 2 Q4W, they may return to dose 1 Q4W at the discretion of the Investigator.
Bimekizumab
Bimekizumab will be administered subcutaneously in 2 different doses.
Interventions
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Bimekizumab
Bimekizumab will be administered subcutaneously in 2 different doses.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception up till 20 weeks after last administration of study drug, and have a negative pregnancy test at Visit 1 (Screening) and immediately prior to first dose
* Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active, up till 20 weeks after the last administration of study medication (anticipated 5 half-lives)
Exclusion Criteria
* 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. Note: For any subject with an ongoing serious adverse event (SAE), or a history of serious infections (including herpes zoster or hospitalizations) in PS0016, the Medical Monitor must be consulted prior to the subject's entry into PS0018
* Subject has any current sign or symptom that may indicate a medically significant infection
* Subject has current clinically active infection with Histoplasma, Coccidiodes, Paracoccidioides, Pneumocystis, tuberculosis (TB), nontuberculous mycobacteria (NTMB),Blastomyces, Aspergillus, or Candidiasis (systemic). Any subject diagnosed with Histoplasmosis, Coccidiodes, Paracoccidioides, Pneumocystis, TB, NTMB, Blastomyces, Aspergillus, or Candidiasis (systemic) during PS0016 is excluded from PS0018 even if treatment has been completed.
* Any subject who meets any withdrawal criteria in the feeder study (PS0016) is excluded from participating in the open-label extension study (PS0018)
18 Years
70 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
UCB (001 844 599 2273)
Locations
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Ps0018 701
High Point, North Carolina, United States
Ps0018 704
Bexley, Ohio, United States
Ps0018 101
Carlton, , Australia
Ps0018 103
East Melbourne, , Australia
Ps0018 102
Kogarah, , Australia
Ps0018 104
Woolloongabba, , Australia
Ps0018 201
Ajax, , Canada
Ps0018 203
London, , Canada
Ps0018 202
Windsor, , Canada
Ps0018 501
Chisinau, , Moldova
Countries
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References
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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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2016-002934-57
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PS0018
Identifier Type: -
Identifier Source: org_study_id
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