A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque Psoriasis
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- 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 CRITERIA
Exclusion Criteria:
- Participants weighing ≤ 30.0 kg at screening for Cohort 1 (age 12 to < 18 years), Part A and Part B. Participants weighing ≤ 13.0 kg at screening for Cohort 2 (age 4 to < 12 years), Part A and Part B.
- Other forms of psoriasis
- History of recent infection
- Prior exposure to deucravacitinib (BMS-986165) or active comparator
- Evidence of active TB for LTE period
Other protocol-defined inclusion/exclusion criteria apply
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Plaque Psoriasis
Age (in years)
4 - 18
Phase
Phase 3
Participants needed
153
Est. Completion Date
Sep 9, 2031
Treatment type
Interventional
Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov identifier
NCT04772079
Study number
IM011126
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?