A Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult Study Participants Wi… (NCT06011733) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult Study Participants With Moderate to Severe Plaque Psoriasis
China133 participantsStarted 2023-10-31
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Percentage of Participants With Psoriasis Area Severity Index 90 (PASI90) Response at Week 16
Timeframe: Week 16
2
Percentage of Participants With Investigator´s Global Assessment (IGA) 0/1 Response at Week 16