Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06869551

A Study to Evaluate the Drug Levels, Efficacy, and Safety of Deucravacitinib (BMS-986165) in Pediatric Participants With Juvenile Psoriatic Arthritis

The purpose of this study is to evaluate the drug levels, efficacy, and safety of Deucravacitinib (BMS-986165) in pediatric participants with juvenile psoriatic arthritis.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Juvenile Psoriatic Arthritis Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro de Oncologia Leonardo Da Vinci - ATO Terapias, Fortaleza, Ceará, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must have been diagnosed with Juvenile Psoriatic Arthritis (JPsA).
  • Participants must have at least three joints that are affected by arthritis.
  • Participants must have tried at least one type of medicine for JPsA for at least three months, but it didn't work well or caused problems.

Exclusion criteria

  • Participants must not have been diagnosed with JPsA before 5 years of age.
  • Participants must not have other types of Juvenile Idiopathic Arthritis (JIA) that aren't JPsA,
  • Participants must not have a history of chronic eye inflammation (uveitis), or were diagnosed with uveitis within the last three months.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Treatment and study plan

Deucravacitinib

Drug

Specified dose on specified days

Placebo

Other

Specified dose on specified days

Primary outcomes

  1. Time to first flare during the withdrawal period

    Time frame: From week 16 up to week 42

Secondary outcomes

  1. Trough concentration at steady state (Cminss)

    Time frame: At week 16

  2. Time-averaged steady-state concentration (Cavgss)

    Time frame: At week 16

  3. Steady-state maximum observed concentration (Cmaxss)

    Time frame: At week 16

  4. Number of participants with flare during the withdrawal period

    Time frame: From week 16 up to week 42

  5. Number of participants achieving low disease activity (Juvenile arthritis disease activity 71-joint score based on C-reactive protein (JADAS71-CRP) score: for oligoarthritis 1.1 to 2; for polyarthritis 1.1 to 3.8)

    Time frame: Through week 16 and up to week 42

  6. Number of participants achieving inactive disease (JADAS71-CRP score ≤ 1)

    Time frame: Through week 16 and up to week 42

  7. Number of participants attaining clinical remission for at least 6 consecutive months

    Time frame: At week 42

  8. Number of participants achieving psoriasis area and severity index (PASI) 75

    Time frame: At week 42

  9. Number of participants with adverse events (AEs)

    Time frame: Up to week 42

  10. Number of participants with adverse event of special interest (AESIs)

    Time frame: Up to week 42

  11. Number of participants with AEs leading to discontinuation

    Time frame: Up to week 42

  12. Number of participants with serious adverse events (SAEs)

    Time frame: Up to week 42

  13. Number of participants with Uveitis

    Time frame: Up to week 42

  14. Number of participants achieving each of juvenile idiopathic arthritis-American College of Rheumatology (JIA-ACR) (30/50/70/90)

    Time frame: Through week 16 and up to week 42

  15. Change from baseline in juvenile idiopathic arthritis-American College of Rheumatology (JIA-ACR) Core Criteria

    Time frame: Through week 16 and up to week 42

  16. Number of participants for each assessment who evaluate palatability scale as ≥ 3 (good or better), swallowability scale as ≤ 4 (neutral or easier), and taste scales (Sweetness, Bitterness, Flavor, and Overall Taste) as "None" or "Weak"

    Time frame: At week 16

  17. Assessment of exposure-response (E-R) utilizing steady-state exposure of deucravacitinib from the pharmacokinetic (PK) analysis and efficacy results using JIA-ACR 30

    Time frame: At week 16

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

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

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib in Children and Adolescents From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis

Important dates

Study start
2025
Primary completion
2030
Study completion
2031
First posted
Mar 11, 2025
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.