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Looking for participantsPhase3

A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Children and Adolescent Participants With Moderate to Severe Plaque Psoriasis

Sponsor: Bristol-Myers Squibb

NCT ID: NCT04772079

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Deucravacitinib (drug), Placebo matching deucravacitinib (other)
How long the study runs
Study runs about 150 months (dates as stated)
About the drug or intervention
Deucravacitinib — drug: Specified dose on specified days · Placebo matching deucravacitinib — other: Specified dose on specified days
Patient visit burden
Not specified by the sponsor

In plain English

This study, run by Bristol-Myers Squibb, looks at drug levels, how well a medicine called deucravacitinib works, and how safe it is in children and teenagers aged 4 to under 18 with moderate to severe plaque psoriasis. Plaque psoriasis is a skin condition that causes raised, scaly patches. Participants who finish the Week 52 treatment period in Part A or B may continue into a long-term extension period.

Who can take part

  • Males and females aged 12 to under 18 (Cohort 1) or aged 4 to under 12 (Cohort 2)
  • Have had plaque psoriasis for at least 6 months
  • Have moderate to severe disease
  • Could be treated with light therapy (phototherapy) or medicine that affects the whole body (systemic therapy)
  • Must have completed the Week 52 treatment period in Part A or B to join the long-term extension period

Who may not be able to

  • Weighing 30.0 kg or less (Cohort 1) or under 18.0 kg (Cohort 2) at screening
  • Having other forms of psoriasis
  • A history of recent infection
  • Having taken deucravacitinib (BMS-986165) or another active comparator before
  • Evidence of active TB (tuberculosis) for the long-term extension period
  • Other study rules may also apply — ask the trial team

What taking part involves

  • • Taking the study medicine deucravacitinib so researchers can measure drug levels, how well it works, and its safety
  • • A treatment period lasting up to Week 52 in Part A or B, with a possible long-term extension afterwards
  • • Not stated — ask the trial team

Time commitment: The trial involves at least 52 weeks of treatment, plus a possible long-term extension; details of visits and tests are not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
4 Years to 18 Years
Who
All
Number of participants
153
Started
2021-03-23
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for plaque psoriasis
  • • Phase3 - 153 participants
  • • 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

Who can take part?

  • • Ages 4 Years to 18 Years
  • • Diagnosed with plaque psoriasis

Where?

  • • London - Local Institution - 0029
  • • Connor Downs - Mounts Bay Medical
  • • London - Local Institution - 0092

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Plaque Psoriasis

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 4 Years - 18 Years
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ completed the Week 52 treatment period in Part A or B for long-term extension (LTE) period

What the study is looking for

  • ✓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 treatment that goes through your whole body.
See the full 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 another active comparator. * Evidence of active TB for LTE period. * Other protocol-defined inclusion/exclusion criteria apply.

Where Is This Study? (3 UK sites)

Local Institution - 0029

London WC1N 3JH, United Kingdom

NOT_YET_RECRUITING

Mounts Bay Medical

Connor Downs TR27 5DT, United Kingdom

Recruiting
Site contact (verified)
Richard Burkimsher, Site 001901736 805460

Local Institution - 0092

London SE1 7EH, United Kingdom

NOT_YET_RECRUITING

How to Get in Touch

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Sponsor contact

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-08