Study to Evaluate Effectiveness and Safety in Subjects With Moderate to Severe Psoriasis
- Conditions
- Psoriasis
- Registration Number
- JPRN-jRCT2080223467
- Lead Sponsor
- Bristol-Myers Squibb K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 250
Diagnosis of plaque psoriasis for 6 months
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test, must not be pregnant, lactating, breastfeeding or planning pregnancy
Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment plus 5 half-lives of the study drug plus 90 days.
Any significant acute or chronic medical illness
Blood transfusion within 4 weeks of study drug administration
Inability to tolerate oral medication
Positive hepatitis-B (HBV) surface antigen
Positive hepatitis-C (HCV) antibody
Any history or risk for tuberculosis (TB)
Any major illness/condition or evidence of an unstable clinical condition
Chest X-ray findings suspicious of infection at screening
has received ustekinumab, secukinumab or ixekizumab within 6 months of first administration of study medication
Has received anti-Tumor Necrosis Factor (TNF) inhibitor(s) within 2 months of first administration of study medication
Has received Rituximab within 6 months of first administration of study medication
Topical medications/treatments for psoriasis within 2 weeks of the first administration of any study medication
Any systemic medications/treatments for psoriasis within 4 weeks of the first administration of any study medication
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects reaching a 75% reduction in Psoriasis Area and Severity Index (PASI-75) [ Time Frame: Day 1 to Day 85 ]<br>Number of adverse events (AEs) [ Time Frame: Day 1 to 115 ]
- Secondary Outcome Measures
Name Time Method Proportion of subjects at week 12 with PASI-50 [ Time Frame: Baseline to Week 12 ]<br>Proportion of subjects at week 12 with PASI-75 [ Time Frame: Baseline to Week 12 ]<br>Proportion of subjects at week 12 with PASI-90 [ Time Frame: Baseline to Week 12 ]<br>Proportion of subjects at week 12 with PASI-100 [ Time Frame: Baseline to Week 12 ]<br>static Physician Global Assessment score (sPGA) [ Time Frame: Day 1 to Day 85 ]<br>Dermatology Life Quality Index score (DLQI) [ Time Frame: Day 1 to Day 85 ]<br>Trough observed plasma concentration of BMS-986165 (Ctrough) [ Time Frame: Day 1 to Day 85 ]