A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Bimekizumab in Patients With Chronic Plaque Psoriasis
NCT ID: NCT03025542
Last Updated: 2022-10-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
49 participants
INTERVENTIONAL
2016-12-27
2017-12-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment Arm 1
Subjects randomized in this arm will receive a combination of Bimekizumab and Placebo injections.
Bimekizumab
Based on their randomization subjects will receive a combination of several injections of Bimekizumab.
Placebo
Subjects will receive injections of Placebo.
Treatment Arm 2
Subjects randomized in this arm will receive Bimekizumab injections.
Bimekizumab
Based on their randomization subjects will receive a combination of several injections of Bimekizumab.
Interventions
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Bimekizumab
Based on their randomization subjects will receive a combination of several injections of Bimekizumab.
Placebo
Subjects will receive injections of Placebo.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chronic plaque psoriasis for at least 6 months prior to Screening
* Psoriasis Area and Severity Index (PASI) \>=12 and body surface area (BSA) \>=10% and Investigator's Global Assessment (IGA) score \>=3 on a 5-point scale
* Candidates for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy
* 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
* Subjects with erythrodermic, guttate, pustular form of psoriasis, or drug-induced psoriasis
* History of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline Visit (including herpes zoster)
* High risk of infection in the Investigator's opinion
* Current sign or symptom that may indicate an active infection
* Concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
* Live (includes attenuated) vaccination within the 8 weeks prior to Baseline
* Subjects with concurrent malignancy or history of malignancy during the past 5 years (except for specific malignant condition as defined in the protocol)
* Primary immunosuppressive conditions
* TB infection, high risk of acquiring TB infection, latent TB infection (LTBI), or current or history of NTMB infection
* Laboratory abnormalities, as defined in the study protocol
* Any condition which, in the Investigator's judgement, would make the subject unsuitable for inclusion in the study
* Exposure to more than 1 biological response modifier (limited to anti-TNF or IL-12/-23) or any biologic response modifier during the three months prior to the Baseline Visit
* Subjects have received previous treatment with any anti-IL-17 therapy for the treatment of psoriasis or psoriatic arthritis
* Subjects with a diagnosis of inflammatory conditions other than psoriasis or psoriatic arthritis, including but not limited to rheumatoid arthritis, sarcoidosis, or systemic lupus erythematosus. Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long as they have no active symptomatic disease at Screening or Baseline
* Subjects taking psoriatic arthritis medications other than nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics
18 Years
70 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
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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Ps0016 704
Bexley, Ohio, United States
Ps0016 102
Kogarah, , Australia
Ps0016 101
Melbourne, , Australia
Ps0016 104
Woolloongabba, , Australia
Ps0016 201
Ajax, , Canada
Ps0016 203
London, , Canada
Ps0016 202
Windsor, , Canada
Ps0016 501
Chisinau, , Moldova
Countries
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References
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Oliver R, Krueger JG, Glatt S, Vajjah P, Mistry C, Page M, Edwards H, Garcet S, Li X, Dizier B, Maroof A, Watling M, El Baghdady A, Baeten D, Ionescu L, Shaw S. Bimekizumab for the treatment of moderate-to-severe plaque psoriasis: efficacy, safety, pharmacokinetics, pharmacodynamics and transcriptomics from a phase IIa, randomized, double-blind multicentre study. Br J Dermatol. 2022 Apr;186(4):652-663. doi: 10.1111/bjd.20827. Epub 2021 Dec 27.
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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2016-002368-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PS0016
Identifier Type: -
Identifier Source: org_study_id
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