Psoriasis Clinical Trial
Study to Evaluate Safety and Efficacy of Different Doses of Bimekizumab in Patients With Chronic Plaque Psoriasis
Summary
This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose ranging study to investigate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of Bimekizumab compared with placebo in adult subjects with moderate to severe chronic plaque psoriasis in order to guide the selection of doses and clinical indices in the Phase 3 development program.
Eligibility Criteria
Inclusion Criteria:
Subject has provided informed consent
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:
Subjects with erythrodermic, guttate, pustular form of psoriasis, or drug-induced psoriasis
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)
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There is 1 Location for this study
Fremont California, , United States
Los Angeles California, , United States
Washington District of Columbia, , United States
West Des Moines Iowa, , United States
Rochester New York, , United States
Wilmington North Carolina, , United States
Cleveland Ohio, , United States
Portland Oregon, , United States
Dallas Texas, , United States
Houston Texas, , United States
Houston Texas, , United States
Surrey British Columbia, , Canada
Hamilton Ontario, , Canada
North Bay Ontario, , Canada
Peterborough Ontario, , Canada
Waterloo Ontario, , Canada
Quebec City Quebec, , Canada
Edmonton , , Canada
Quebec City , , Canada
Ostrava Poruba , , Czechia
Pardubice , , Czechia
Praha , , Czechia
Praha , , Czechia
Kecskemet , , Hungary
Oroshaza , , Hungary
Szekszard , , Hungary
Nagoya , , Japan
Shinaga Wa-ku , , Japan
Tokio , , Japan
Tokyo , , Japan
Bialystok , , Poland
Bialystok , , Poland
Gdansk , , Poland
Gdynia , , Poland
Kielce , , Poland
Krakow , , Poland
Lublin , , Poland
Podlaski , , Poland
Warszawa , , Poland
Wroclaw , , Poland
Wroclaw , , Poland
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