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Evaluating Deucravacitinib for Pediatric Plaque Psoriasis

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

PHASE3 · Bristol-Myers Squibb · NCT04772079

This study is testing a new medication called Deucravacitinib to see if it helps children and teens with moderate to severe plaque psoriasis feel better and is safe for them to use.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment153 (estimated)
Ages4 Years to 18 Years
SexAll
SponsorBristol-Myers Squibb (industry)
Drugs / interventionsdeucravacitinib
Locations63 sites (Ciudad Autonoma de Buenos Aires, Buenos Aires and 62 other locations)
Trial IDNCT04772079 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the drug levels, efficacy, and safety of Deucravacitinib in children and adolescents aged 4 to less than 18 years with moderate to severe plaque psoriasis. The study is divided into two cohorts based on age, with Part A focusing on determining appropriate dosing and Part B evaluating the treatment's effectiveness and safety. Participants who complete the initial phases will have the opportunity to enter a long-term extension period to monitor ongoing safety and tolerability.

Who should consider this trial

Good fit: Ideal candidates include males and females aged 4 to less than 18 years with a diagnosis of moderate to severe plaque psoriasis.

Not a fit: Patients with other forms of psoriasis or those who have previously been treated with deucravacitinib may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective treatment option for pediatric patients suffering from moderate to severe plaque psoriasis.

How similar studies have performed: Other studies evaluating similar treatments for plaque psoriasis have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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

* 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.

Where this trial is running

Ciudad Autonoma de Buenos Aires, Buenos Aires and 62 other locations

+13 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Plaque Psoriasis, Adolescent Psoriasis, BMS-986165, Clinical trial, Deucravacitinib, Pediatric, Pediatric Psoriasis, Psoriasis

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.