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A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque Psoriasis
The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in pediatric participants aged 4 to \<18 years with moderate to severe plaque psoriasis. This study includes two cohorts; Cohort 1 (age 12 to \<18 years) and Cohort 2 (age 4 to \<12 years), with two parts; for each cohort. Part A will evaluate the drug levels of BMS-986165 to enable selection of 2 dose levels to be studied in Part B. Part B will assess the efficacy and safety of two dose levels in pediatric participants with moderate to severe plaque psoriasis. The 5-year long-term extension (LTE) period will observe the long-term safety and tolerability of deucravacitinib in pediatric participants with psoriasis who have completed Parts A or B of the study.
Details
| Lead sponsor | Bristol-Myers Squibb |
|---|---|
| Phase | PHASE3 |
| Status | RECRUITING |
| Enrolment | 153 |
| Start date | Tue Mar 23 2021 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Thu Sep 08 2033 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Plaque Psoriasis
Interventions
- Deucravacitinib
- Placebo matching deucravacitinib
Countries
France, Japan, United Kingdom, Germany, Poland, Mexico, South Korea, Argentina, Canada, Romania, Australia, Spain, Brazil