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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). SLE is a chronic autoimmune disease where the immune system mistakenly attacks healthy tissues, causing inflammation and damage to various parts of the body. The medication being tested, deucravacitinib, is taken orally in the form of a film-coated tablet. The study also includes a comparison with a placebo to evaluate the effectiveness and safety of deucravacitinib.

The purpose of this study is to determine if deucravacitinib is more effective than a placebo in treating people with active SLE. Participants in the study will be randomly assigned to receive either deucravacitinib or a placebo. The study will last for a period of 52 weeks, during which participants will be monitored for their response to the treatment. The main goal is to see how many participants achieve a significant improvement in their SLE symptoms by the end of the study period.

Throughout the study, participants will be assessed for changes in their condition, including improvements in joint pain, skin rashes, and overall disease activity. The study will also track any side effects or adverse events that may occur. By the end of the study, researchers hope to gather valuable information on the potential benefits and risks of using deucravacitinib for treating SLE, which could lead to better treatment options for those affected by this condition.

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 deucravacitinib 3 mg tablet or a placebo. A placebo is a tablet that looks like the real medication but does not contain the active substance.

    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

    You will take the assigned tablet orally once a day. The duration of the treatment is planned for up to 52 weeks.

    It is important to take the medication as directed and not to miss any doses to ensure the study's accuracy.

  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 may include physical exams, blood tests, and other assessments.

    These check-ups are crucial to ensure your safety and to gather data on the medication's effectiveness.

  4. Step 4

    Reporting symptoms and side effects

    You will be asked to report any symptoms or side effects you experience during the study. This information is vital for assessing the safety of the medication.

    If you experience any severe side effects, you should inform the study team immediately.

  5. Step 5

    Completion of the study

    At the end of the 52-week period, you will have a final assessment to evaluate the overall effects of the treatment.

    The study team will discuss the results with you and provide guidance on any further steps if necessary.

Who can join the trial?

11 criteria

  • Participants must be **male or female** and between **18 to 75 years old**.
  • 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) antibody**
    • Participants must have **active lupus**, which means:
      • A total **SLEDAI-2K score** of 6 points or more
      • A clinical **SLEDAI-2K score** of 4 points or more
      • 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** (medications that reduce the activity of the immune system).
      • Participants may also be on **corticosteroids** (a type of medication that reduces inflammation).

Who cannot join the trial?

1 criterion

  • Having an active case of Systemic Lupus Erythematosus (SLE), which is a disease where the immune system attacks its 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 for short. SLE is an autoimmune disease, which means the body's immune system mistakenly attacks its own tissues. This can cause inflammation and damage in different parts of the body. Deucravacitinib works by targeting specific pathways in the immune system to reduce this inflammation and help control the symptoms of SLE. The goal of using deucravacitinib in this study is to see if it can be more effective than a placebo in improving the condition of people with 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 signaling pathways that can lead to inflammation. Deucravacitinib is classified as a selective TYK2 inhibitor in pharmacology.

Investigated diseases

Systemic Lupus Erythematosus – Systemic Lupus Erythematosus (SLE) 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 severity and specific symptoms can change over time, making it a complex condition to manage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500700-22-00Protocol codeIM011247Estimated enrolment516 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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