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Study on the Effectiveness and Safety of Deucravacitinib for Children and Teens with Juvenile Psoriatic Arthritis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called Juvenile Psoriatic Arthritis (JPsA), which affects children and teenagers. JPsA is a type of arthritis that not only causes joint pain and swelling but also involves skin problems similar to psoriasis, such as red, scaly patches. The trial will test a medication called deucravacitinib, also known by its code name BMS-986165. This medication is taken as a film-coated tablet and is being compared to a placebo to see if it can effectively manage the symptoms of JPsA in young participants.

The purpose of the study is to determine if deucravacitinib is more effective than a placebo in treating JPsA in children and adolescents aged 5 to 18. Participants will take the medication or placebo orally over a period of time, and researchers will monitor how long it takes for the first flare-up of the disease to occur. The study will also assess how much the disease improves, how many participants experience a reduction in symptoms, and how well the medication is tolerated, including its taste and ease of swallowing.

Throughout the study, researchers will keep track of any side effects and monitor the overall safety of deucravacitinib. They will also evaluate the amount of the medication in the body and its impact on the disease. The trial aims to provide valuable information on the effectiveness and safety of deucravacitinib for managing Juvenile Psoriatic Arthritis in young patients.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    Participants will begin taking deucravacitinib, a medication in the form of a film-coated tablet, administered orally.

    The dosage and frequency of administration will be determined by the study protocol and communicated to participants at the start of the trial.

  2. Step 2

    Monitoring and assessment

    Participants will be monitored regularly to evaluate the amount of deucravacitinib in the body, particularly at week 16.

    Assessments will include checking for any flare-ups of the disease and measuring improvement in symptoms at weeks 16 and 42.

    Participants will also be asked about the ease of swallowing the medication and its taste at week 16.

  3. Step 3

    Randomized withdrawal phase

    Between weeks 16 to 42, some participants may be randomly selected to stop taking the medication to compare the time it takes for a flare-up to occur with those who continue the treatment.

    The goal is to evaluate the effectiveness of deucravacitinib compared to a placebo.

  4. Step 4

    Long-term evaluation

    Participants will be assessed for long-term outcomes, such as the number of individuals achieving low or no disease activity and those with a 75% improvement in skin symptoms by week 42.

    The study will also monitor any side effects, their severity, and any cases of an eye condition called uveitis.

Who can join the trial?

5 criteria

  • Participants must be diagnosed with Juvenile Psoriatic Arthritis (JPsA). This means they have arthritis and skin problems like Psoriasis (PsO)dactylitis), changes in nails, or a close family member with Psoriasis.
  • Participants need to have at least three joints affected by arthritis. This could mean these joints are swollen, painful, or don't move as well as they should.
  • Participants should have tried at least one type of medicine for JPsA for at least three months, but it didn't work well or caused problems.
  • Participants must be between the ages of 5 and 18.
  • Both boys and girls can participate in the study.
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Investigated drugs

Deucravacitinib is a medication being studied to see if it can help children and teenagers with Juvenile Psoriatic Arthritis, a condition that causes joint pain and swelling. The trial aims to determine if this medication is more effective than not taking any active treatment.

What is already known about the treatment

Deucravacitinib – This medication is administered orally and is currently being studied in a Phase 3 clinical trial to assess its effectiveness and safety in treating Juvenile Psoriatic Arthritis (JPsA) in children and adolescents aged 5 to 18. Deucravacitinib is a promising treatment option in medical literature, particularly for its potential benefits in managing JPsA. It works by selectively inhibiting the enzyme tyrosine kinase 2 (TYK2), which plays a role in the inflammatory process. This medication is classified as a selective TYK2 inhibitor, and its main therapeutic indication is to reduce inflammation and alleviate symptoms associated with JPsA.

Investigated diseases

Juvenile Psoriatic Arthritis – This is a type of arthritis that affects children and teenagers, typically between the ages of 5 and 18. It is characterized by joint inflammation and swelling, often accompanied by skin symptoms similar to psoriasis, such as red, scaly patches. The disease can cause stiffness, pain, and reduced range of motion in the affected joints. Over time, it may lead to joint damage if not managed properly. The condition can vary in severity, with some children experiencing mild symptoms and others having more significant joint involvement. It is a chronic condition, meaning it can persist for a long time, often with periods of flare-ups and remission.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2024-517262-41-00Protocol codeIM011-1071Estimated enrolment64 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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