A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Children and Adolescent Participants With Moderate to Severe Plaque Psoriasis
Key facts
- Where
- Berlin, Dresden, Hamburg, Mainz, and Muenster, GermanySee the 5 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 4 and 18 years old?
Where in Germany
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyTaking people
- Technische Universitaet DresdenDresden, GermanyTaking people
- Katholisches Kinderkrankenhaus Wilhelmstift gGmbHHamburg, GermanyTaking people
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöRMainz, GermanyTaking people
- Universitaet MuensterMuenster, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT04772079EU 2022-502519-13-00
- Record updated
- 26 October 2026
- Original description
The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in children and adolescent 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 children and adolescent 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 children and adolescent participants with psoriasis who have completed Parts A or B of the study.Read full original descriptionShow less
A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Deucravacitinib (BMS-986165) in Pediatric Subjects With Moderate to Severe Plaque Psoriasis
The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in children and adolescent 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 children and adolescent 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 children and adolescent participants with psoriasis who have completed Parts A or B of the study.
Inclusion: Males and females aged 12 to <18 years for Cohort 1. Males and females aged 4 to <12 years for Cohort 2; Plaque psoriasis for at least 6 months; Moderate to severe disease; Candidate for phototherapy or systemic therapy; Must have completed the Week 52 treatment period in Part A or B for long-term extension (LTE) period.
Exclusion: Prior exposure to deucravacitinib (BMS-986165) or another active comparator; History of recent infection; Participants weighing ≤ 30.0 kg at screening for Cohort 1 (age 12 to < 18 years), Part A and Part B. Participants weighing < 18.0 kg at screening for Cohort 2 (age 4 to < 12 years), Part A and Part B; Other forms of psoriasis; Evidence of active TB for LTE period; Other protocol-defined inclusion/exclusion criteria apply.