Status:
RECRUITING
A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque Psoriasis
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
4-18 years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
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
- 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.
- 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.
Key Trial Info
Start Date :
March 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 8 2033
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT04772079
Start Date
March 23 2021
End Date
September 8 2033
Last Update
September 25 2025
Active Locations (63)
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1
Instituto de Neumonologia Y Dermatologia
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1425
2
Psoriahue
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1425DKG
3
CONEXA Investigacion Clinica S.A.
Buenos Aires, Argentina, 1012
4
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, Argentina, C1056ABI