A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165)
The purpose of this study is to evaluate the efficacy, safety, and drug levels of Deucravacitinib (BMS-986165) in adolescent participants with moderate to severe plaque psoriasis
| Condition(s) | Plaque Psoriasis |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | The purpose of this study is to evaluate the efficacy, safety, and drug levels of Deucravacitinib (BMS-986165) in adolescent participants with moderate to severe plaque psoriasis |
| Who can participate | Inclusion Criteria * Participants must have stable plaque psoriasis for 6 months or more prior to Screening. * Participants must have moderate to severe psoriasis defined by:. i) Psoriasis Area and Severity Index (PASI) ≥ 12, at screening visit and Day 1. ii) Static Physician's Global Assessment (sPGA) ≥ 3, at screening visit and Day 1. iii) Body Surface Area (BSA) ≥ 10% involvement, at screening visit and Day 1. \- A female (as assigned at birth) participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:. i) Is not an individual of childbearing potential (IOCBP). ii) Is an IOCBP and using a contraceptive method that is highly effective (with a failure rate of \< 1% per year) during the study intervention period and f |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Lead sponsor | Bristol-Myers Squibb |
| Locations | Birmingham, Alabama, United States; Birmingham, Alabama, United States; Phoenix, Arizona, United States; Fountain Valley, California, United States; Fremont, California, United States; Los Angeles, California, United States (+117 more sites) |
| Start date | 2025-12-03 |
| NCT ID | NCT06979453 |
| Official listing | https://clinicaltrials.gov/study/NCT06979453 |