PS0041
PS0041
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult Study Participants With Moderate to Severe Plaque Psoriasis
Brief summary
The primary purpose of this study is to compare the efficacy of bimekizumab administered subcutaneously (sc) for 16 weeks versus placebo in the treatment of study participants with moderate to severe plaque psoriasis (PSO).
Medical Condition
Chronic Plaque Psoriasis
Min. Age
18
Years
Max. Age
-
Who Can Join?
All
Status
Active, not recruiting
Inclusion criteria
- Study participant is Chinese male or female ≥18 years of age - Study participant has plaque psoriasis (PSO) for ≥6 months prior to the Screening Visit - Study participant has Psoriasis Area and Severity Index (PASI) ≥12 and body surface area (BSA) affected by PSO ≥10% and Investigator’s Global Assessment (IGA) score ≥3 on a 5-point scale. - Study participant is a candidate for systemic PSO therapy and/or phototherapy - Female study participants must be postmenopausal or permanently sterilized or if childbearing potential must be willing to use protocol defined highly effective method of contraception throughout the duration of the study until 17 weeks after last administration of investigational medicinal product (IMP) and have a negative pregnancy test at Screening and prior to first dose
Exclusion criteria
-Female study participant who is breastfeeding, pregnant, or plans to become pregnant during the study or within 17 weeks following the final dose of IMP -Study participant has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic, guttate, or drug-induced PSO) -Study participant has an active infection or history of infection(s) as defined in the protocol -Study participant has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection.Study participant has a past history of active TB involving any organ system unless adequately treated and is proven to be fully recovered upon consult with a TB specialist -Study participant has a diagnosis of inflammatory conditions other than PSO vulgaris or psoriatic arthritis (PsA) -Study participant has presence of significant uncontrolled neuropsychiatric disorder. Study participants with history of suicide attempt within the 5 years prior to the Screening Visit must be excluded. Study participants with history of suicide attempt more than 5 years prior to the Screening Visit must be evaluated by a mental health care practitioner before enrollment.
Study Medication Description
Study Medication:
Bimzelx®
Other Descriptive Name:
bimekizumab
Placebo
Yes
Comparator:
No
Refer to a friend
Study Dates
October 2023
Actual Start Date of Enrollment
February 2025
Planned Study Completion Date