Study to Evaluate Safety and Efficacy of Different Doses of Bimekizumab in Patients With Chronic Plaque Psoriasis
NCT ID: NCT02905006
Last Updated: 2022-07-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
250 participants
INTERVENTIONAL
2016-08-31
2017-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Bimekizumab in Patients With Chronic Plaque Psoriasis
NCT03025542
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
NCT03598790
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
NCT03410992
A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Patients With Chronic Plaque Psoriasis
NCT03010527
A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
NCT03536884
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
Bimekizumab dosing regimen 1
Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
Bimekizumab dosing regimen 2
Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
Bimekizumab dosing regimen 3
Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
Bimekizumab dosing regimen 4
Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
Bimekizumab dosing regimen 5
Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
Placebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Chronic plaque psoriasis for at least 6 months prior to Screening
* PASI (Psoriasis Area and Severity Index) \>=12 and BSA (body surface area) \>=10% and IGA (Investigator's Global Assessment) score 3 or greater 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
* 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
Exclusion Criteria
* Subject has any severe, progressive and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, gastrointestinal or neurological disease
* Subject has any significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol
* Subject taking prohibited psoriatic medications
* Subject receiving any live vaccines within 8 weeks prior to the Baseline and subjects receiving Bacillus Calmette-Guerin (BCG) vaccination within 1 year prior to study drug administration
* Subject has previously received treatment with any anti-interleukin-17 (anti-IL-17) therapy or has been exposed to more than 1 biological response modifier (limited to anti-tumor necrosis factor (TNF) or IL-12/23) for psoriatic arthritis or psoriasis prior to the Baseline
* Subject has any current sign or symptom that may indicate an active infection (except for common cold)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Parexel
INDUSTRY
UCB Biopharma S.P.R.L.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
UCB Cares
Role: STUDY_DIRECTOR
+1 844 599 2273 (UCB)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ps0010 711
Fremont, California, United States
Ps0010 708
Los Angeles, California, United States
Ps0010 706
Washington D.C., District of Columbia, United States
Ps0010 704
West Des Moines, Iowa, United States
Ps0010 718
Rochester, New York, United States
Ps0010 738
Wilmington, North Carolina, United States
Ps0010 736
Cleveland, Ohio, United States
Ps0010 712
Portland, Oregon, United States
Ps0010 733
Dallas, Texas, United States
Ps0010 702
Houston, Texas, United States
Ps0010 709
Houston, Texas, United States
Ps0010 203
Surrey, British Columbia, Canada
Ps0010 204
Hamilton, Ontario, Canada
Ps0010 201
North Bay, Ontario, Canada
Ps0010 206
Peterborough, Ontario, Canada
Ps0010 205
Waterloo, Ontario, Canada
Ps0010 214
Québec, Quebec, Canada
Ps0010 209
Edmonton, , Canada
Ps0010 214
Québec, , Canada
Ps0010 300
Ostrava Poruba, , Czechia
Ps0010 303
Pardubice, , Czechia
Ps0010 301
Prague, , Czechia
Ps0010 304
Prague, , Czechia
Ps0010 404
Kecskemét, , Hungary
Ps0010 400
Orosháza, , Hungary
Ps0010 405
Szekszárd, , Hungary
Ps0010 502
Nagoya, , Japan
Ps0010 501
Shinaga Wa-ku, , Japan
Ps0010 503
Tokyo, , Japan
Ps0010 504
Tokyo, , Japan
Ps0010 600
Bialystok, , Poland
Ps0010 611
Bialystok, , Poland
Ps0010 605
Gdansk, , Poland
Ps0010 610
Gdynia, , Poland
Ps0010 604
Kielce, , Poland
Ps0010 608
Krakow, , Poland
Ps0010 606
Lublin, , Poland
Ps0010 603
Podlaski, , Poland
Ps0010 607
Warsaw, , Poland
Ps0010 601
Wroclaw, , Poland
Ps0010 609
Wroclaw, , Poland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016-001891-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PS0010
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.