An Investigational Study to Evaluate Experimental Medication BMS-986165 in Japanese Participants with Moderate-to-Severe Psoriasis
Phase 3
Completed
- Conditions
- psoriasis
- Registration Number
- JPRN-jRCT2080224603
- Lead Sponsor
- Bristol-Myers Squibb K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
a. For participants with plaque psoriasis:
i. Stable plaque psoriasis for at least 6 months
ii. Moderate to severe disease
iii. Candidate for phototherapy or systemic therapy
b. Additional protocol-specified inclusion criteria apply for subjects with psoriatic arthritis, erythrodermic psoriasis, or generalized pustular psoriasis
Exclusion Criteria
1.Guttate, inverse, or drug-induced psoriasis at Screening or Baseline
2.History of recent infection
3.Prior exposure to BMS-986165
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>- sPGA 0/1 response assessed as a proportion of subjects with a sPGA score of 0 or 1 at Week 16<br>- PASI 75 response assessed as a proportion of subjects who achieve a 75% improvement from baseline in the PASI score at Week 16
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>The following additional endopoints will be meaured through Week 52<br>-Percentage of participants who achieve sPGA score of 0 or 1 response<br>-Percentage of participants who achieve PASI 75<br>-Percentage of participants who achieve PASI 90<br>-Percentage of participants who achieve PASI 100 <br>-American College of Rheumatology Criteria (ACR20) response in participants with psoriatic arthritis<br>-Change from baseline in the ACR core set in participants with psoriatic arthritis<br>-Change from baseline in Psoriasis Symptoms and Signs Diary (PSSD) score<br>-Percentage of participants who achieve Scalp Specific (ss)-PGA score 0 or 1 among participants with a baseline ss-PGA score more than 3<br>-Percentage of participants who achieve PGA-F score 0 or 1 among participants with a baseline PGA-F score more than 3 <br>-Percentage of participants who achieve palmoplantar (pp)-PGA score of 0 or 1 among participants with a baseline pp-PGA score more than 3