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Study on the Effectiveness and Safety of Deucravacitinib for Patients with Active Systemic Lupus Erythematosus (SLE)

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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 effects of a medication called deucravacitinib on individuals with Systemic Lupus Erythematosus (SLE), a chronic autoimmune disease where the immune system attacks healthy tissues, causing inflammation and damage to various parts of the body. The medication is provided in the form of a film-coated tablet and is taken orally. The study also includes a comparison with a placebo to evaluate the effectiveness and safety of deucravacitinib.

The purpose of the study is to determine if deucravacitinib is more effective than a placebo in treating participants with active SLE. Participants will be randomly assigned to receive either deucravacitinib or a placebo. The study will last for a period of time, during which participants will be monitored for changes in their condition and any side effects. The main goal is to see how many participants achieve a significant improvement in their SLE symptoms after 52 weeks of treatment.

Throughout the study, participants will undergo regular assessments to track their progress and any changes in their health. These assessments will include evaluations of joint involvement, skin conditions, and overall disease activity. The study aims to provide valuable information on the potential benefits and risks of using deucravacitinib for treating SLE, contributing to the understanding of how this medication can help manage the disease.

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

    Upon joining the study, you will be randomly assigned to receive either the study medication, deucravacitinib, or a placebo. A placebo is a tablet that looks like the medication but does not contain the active ingredient.

    The study is designed to be double-blind, meaning neither you nor the study team will know which treatment you are receiving. This helps ensure the results are unbiased.

  2. Step 2

    Medication administration

    If you are assigned to the deucravacitinib group, you will take a 3 mg tablet once daily by mouth. If you are in the placebo group, you will take a placebo tablet once daily by mouth.

    The duration of the medication administration is up to 52 weeks, during which you will continue your regular background therapy for lupus, which may include anti-malarial agents, immunosuppressants, and corticosteroids.

  3. Step 3

    Regular check-ups

    Throughout the study, you will have regular check-ups to monitor your health and the effects of the treatment. These check-ups will include physical examinations, blood tests, and other assessments as needed.

    You will be asked to report any side effects or changes in your condition to the study team promptly.

  4. Step 4

    Evaluation of treatment effectiveness

    The primary goal of the study is to determine if deucravacitinib is more effective than the placebo in treating systemic lupus erythematosus (SLE). This will be assessed by measuring your response to treatment at week 52.

    Secondary evaluations will include improvements in skin symptoms, joint involvement, and overall disease activity, as well as any changes in fatigue levels.

  5. Step 5

    Completion of the study

    At the end of the 52-week period, you will have a final evaluation to assess the overall impact of the treatment on your condition.

    You will be informed about the treatment you received during the study, and the study team will discuss any further steps or recommendations for your ongoing care.

Who can join the trial?

10 criteria

  • Participants must be male or female and aged between 18 to 75 years.
  • Participants must have been diagnosed with Systemic Lupus Erythematosus (SLE) at least 24 weeks before the screening.
  • Participants must meet the 2019 classification criteria for SLE set by the European Alliance of Associations for Rheumatology/American College of Rheumatology.
  • Participants must test positive for at least one of the following lupus-related autoantibodies at the time of screening:
    • Antinuclear antibodies (ANA) with a level of 1:80 or higher
    • Anti-dsDNA antibody
    • Anti-Smith (anti-Sm)
    • Participants must have active lupus, which means:
      • A total SLEDAI-2K score of 6 points or more. (SLEDAI-2K is a tool used to measure disease activity in lupus.)
      • A clinical SLEDAI-2K score of 4 points or more, which must include joint involvement, cutaneous vasculitis (inflammation of blood vessels in the skin), and/or rash.
      • Participants must be on stable background therapy with anti-malarial agents and/or immunosuppressants. (These are medications used to manage lupus.)
      • Participants may also be taking corticosteroids. (These are medications that help reduce inflammation.)

Who cannot join the trial?

1 criterion

  • Having an active case of Systemic Lupus Erythematosus (SLE), which is a condition where the immune system attacks the body's own tissues.
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Investigated drugs

Deucravacitinib is a medication being studied for its potential to help people with a condition called systemic lupus erythematosus, or SLE. SLE is an autoimmune disease, which means the body's immune system mistakenly attacks its own tissues. Deucravacitinib works by targeting specific pathways in the immune system that are involved in inflammation and immune response. By doing this, it aims to reduce the symptoms of SLE, such as joint pain, skin rashes, and fatigue, and improve the overall quality of life for people with this condition. The goal of the trial is to see if deucravacitinib is more effective than a placebo in treating SLE.

What is already known about the treatment

Deucravacitinib – Deucravacitinib is administered orally in the form of a tablet. It is currently being studied in clinical trials for its effectiveness and safety in treating active Systemic Lupus Erythematosus (SLE), a chronic autoimmune disease. The main therapeutic indication for deucravacitinib is to help manage symptoms of SLE. At the molecular level, it works by selectively inhibiting an enzyme called TYK2, which plays a role in the immune system's inflammatory response. Deucravacitinib is classified as a selective TYK2 inhibitor in pharmacology.

Investigated diseases

Systemic Lupus Erythematosus (SLE) – Systemic Lupus Erythematosus is an autoimmune disease where the immune system mistakenly attacks healthy tissues in the body. It can affect various parts of the body, including the skin, joints, kidneys, brain, and other organs. The disease often presents with symptoms such as fatigue, joint pain, skin rashes, and fever. Over time, SLE can lead to inflammation and damage in the affected organs. The progression of the disease can vary greatly among individuals, with periods of flares and remissions. The exact cause of SLE is unknown, but it is believed to involve a combination of genetic, environmental, and hormonal factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500699-76-00Protocol codeIM011246Estimated enrolment531 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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