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Study on Long-Term Safety and Efficacy of Deucravacitinib for Patients 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 clinical trial is focused on studying the long-term safety and effectiveness of a medication called deucravacitinib in individuals with moderate-to-severe plaque psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches to appear on the skin. The study involves taking deucravacitinib, which is provided in the form of a film-coated tablet, and aims to understand how safe and tolerable it is for long-term use in treating this condition.

Participants in the study will receive deucravacitinib, and some may receive a placebo to compare the effects. The study is designed to observe any side effects or adverse events that may occur over time. The goal is to gather information on how well the medication works and how safe it is for people with moderate-to-severe plaque psoriasis.

The study will be conducted over a period of time, allowing researchers to collect data on the medication's impact on the skin condition. Participants will be monitored for any changes in their condition and any potential side effects. This information will help in understanding the long-term benefits and risks of using deucravacitinib for treating plaque psoriasis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after completing the required treatment period in a previous study of BMS-986165 for moderate-to-severe plaque psoriasis.

    Eligibility requires the ability to sign an informed consent form and, for women, a negative pregnancy test 24 hours before starting the study medication.

  2. Step 2

    Medication administration

    The study involves taking a medication called deucravacitinib, which is provided in the form of a film-coated tablet.

    The medication is taken orally. The specific dosage and frequency are determined by the study protocol.

  3. Step 3

    Monitoring and assessments

    Throughout the study, regular assessments are conducted to monitor safety and effectiveness.

    Primary focus is on identifying any adverse events or serious adverse events that may occur.

  4. Step 4

    Evaluation of treatment response

    Secondary evaluations include measuring the response of the skin condition using criteria such as sPGA 0/1 response and PASI 75 response.

  5. Step 5

    Completion of the study

    The study is estimated to conclude by August 7, 2026, with ongoing assessments until that date.

Who can join the trial?

3 criteria

  • Must have completed the required treatment period in a related study of BMS-986165 for moderate-to-severe plaque psoriasis. This is a skin condition that causes red, scaly patches.
  • Must be willing to participate in the study and able to sign the informed consent form. This means you agree to take part in the study and understand what it involves.
  • Women must not be pregnant, breastfeeding, or planning to become pregnant during the study. A negative urine pregnancy test is required 24 hours before starting the study medication.

Who cannot join the trial?

10 criteria

  • Patients with other skin conditions that might interfere with the study.
  • Patients who have had a recent infection that required treatment.
  • Patients with a history of certain types of cancer.
  • Patients who are pregnant or breastfeeding.
  • Patients who have used certain medications recently that could affect the study results.
  • Patients with a history of drug or alcohol abuse.
  • Patients with certain heart conditions.
  • Patients with liver or kidney problems.
  • Patients who have participated in another clinical trial recently.
  • Patients with a known allergy to the study medication.
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Investigated drugs

BMS-986165 is a medication being studied for its long-term safety and effectiveness in treating moderate-to-severe plaque psoriasis. This medication is part of a clinical trial to understand how well it works and how safe it is for patients to use over an extended period.

What is already known about the treatment

BMS-986165 – This medication is administered orally in the form of tablets. It is currently being studied in clinical trials to assess its long-term safety and effectiveness for treating moderate-to-severe plaque psoriasis. The main therapeutic indication for BMS-986165 is to manage and alleviate symptoms associated with this skin condition. At the molecular level, it works by selectively inhibiting specific enzymes involved in the inflammatory process, thereby reducing inflammation and plaque formation. BMS-986165 is classified pharmacologically as a selective tyrosine kinase 2 (TYK2) inhibitor.

Investigated diseases

Moderate-to-Severe Plaque Psoriasis – This is a chronic skin condition characterized by the development of thick, red patches covered with silvery-white scales. These patches, known as plaques, can appear anywhere on the body but are most commonly found on the elbows, knees, scalp, and lower back. The disease progresses through cycles, with periods of flare-ups followed by times of remission. During flare-ups, the plaques can become itchy, painful, and may crack or bleed. The severity of the condition can vary, with moderate-to-severe cases involving larger areas of the body and more intense symptoms. The exact cause is not fully understood, but it is believed to involve an immune system dysfunction.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502361-15-00Protocol codeIM011-075Estimated enrolment1 659 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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