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Study of deucravacitinib compared to placebo in adolescents aged 12-17 years with moderate to severe plaque psoriasis

Fast replyInvestigationalNo placebo
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What is this trial about?

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

This study focuses on evaluating a medication called deucravacitinib (also known as BMS-986165) for treating moderate to severe plaque psoriasis in young people between 12 and 18 years old. Plaque psoriasis is a skin condition that causes red, thick, scaly patches on the skin. The purpose of this research is to determine how well the medication works and how safe it is for adolescent patients.

The study will test deucravacitinib against placebo in participants who have had plaque psoriasis for at least 6 months and who could benefit from whole-body treatment. The medication comes in the form of film-coated tablets that are taken by mouth. During the study, researchers will monitor how the skin condition improves and track any changes in participants' health.

The main focus will be on measuring improvements in the skin condition after 16 weeks of treatment. The study will also look at how the medication affects participants' growth and development. Throughout the study, doctors will regularly check participants' overall health, including their height, weight, and physical development.

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 assessment and qualification

    Your eligibility for the study will be evaluated if you are between 12 and 18 years old and have had moderate to severe plaque psoriasis for at least 6 months

    The condition should be stable and require systemic treatment (medication that affects the entire body) or light therapy

  2. Step 2

    Treatment phase - first 16 weeks

    You will be randomly assigned to receive either deucravacitinib (active medication) or a placebo (inactive substance) in the form of oral tablets

    The medication or placebo will be taken by mouth daily

    Neither you nor your doctor will know whether you are receiving the actual medication or placebo

  3. Step 3

    Evaluation at week 16

    Your skin condition will be assessed using two main measurements:

    The PASI score (a tool that measures the severity and area of psoriasis)

    The sPGA score (a measurement of how clear your skin has become)

    Blood tests will be performed to check antibody levels for measles, tetanus, and pertussis

    Your growth, weight, and physical development will be monitored

  4. Step 4

    Long-term extension phase

    After the initial 16 weeks, the study continues with long-term monitoring

    Regular assessments of your skin condition will continue

    Ongoing monitoring of your growth, weight, and development

    Regular safety checks including physical examinations and monitoring of vital signs

Who can join the trial?

5 criteria

  • Age between 12 and 17 years old
  • Must have had moderate to severe plaque psoriasis that has been stable for at least 6 months
  • Must be suitable for either:
    • Systemic therapy (medications that work throughout the entire body, usually taken as pills or injections)
    • Phototherapy (treatment using special ultraviolet light)
    • Both males and females can participate

Who cannot join the trial?

13 criteria

  • Age below 12 years or 18 years and above
  • Previous treatment with deucravacitinib (the study medication)
  • Active or chronic infections, including tuberculosis or hepatitis B or C
  • History of severe allergic reactions to medications
  • Current diagnosis of other forms of psoriasis besides plaque psoriasis
  • Significant heart, liver, or kidney problems
  • Active or recent cancer (within past 5 years)
  • Pregnancy or breastfeeding
  • Use of other medications for psoriasis that could interfere with the study
  • Mental health conditions that could affect participation in the study
  • Any condition that, in the opinion of the study doctor, would make it unsafe to participate
  • Unable to follow study procedures or attend scheduled visits
  • Participation in another clinical trial within the past 30 days
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Investigated drugs

  • Deucravacitinib

    is a medication being studied for treating moderate to severe plaque psoriasis in adolescents. It works by targeting specific proteins in the immune system that are involved in causing inflammation and skin symptoms in psoriasis. This medication is taken orally and aims to reduce the severity of psoriasis plaques and improve the overall condition of the skin.

  • Placebo

    is an inactive substance that looks identical to the real medication but contains no active ingredients. It is used as a comparison to determine how effective the actual treatment is.

What is already known about the treatment

Deucravacitinib – An oral medication administered in tablet form that represents a novel class of selective tyrosine kinase 2 (TYK2) inhibitors being investigated for the treatment of moderate to severe plaque psoriasis in adolescents aged 12 to 18 years. The drug works by blocking TYK2, a specific enzyme involved in the inflammatory signaling pathway that contributes to psoriasis development, thereby reducing inflammation and skin symptoms. As a first-in-class selective TYK2 inhibitor, deucravacitinib belongs to the broader family of Janus kinase (JAK) inhibitors but demonstrates higher selectivity for TYK2, which may result in an improved safety profile compared to less selective JAK inhibitors.

Investigated diseases

Plaque Psoriasis - A chronic skin condition that causes cells to build up rapidly on the surface of the skin, forming thick, silvery scales and itchy, dry, red patches that can be painful. The patches most commonly appear on the knees, elbows, trunk, and scalp. The condition occurs when the immune system sends faulty signals, causing skin cells to grow too quickly. In moderate to severe cases, the patches can cover large areas of the body, with periods of flare-ups alternating with periods of remission. The condition can begin at any age but most often develops in adulthood.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2023-506296-97-00Protocol codeIM011-1128Estimated enrolment366 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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