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Study on Long-Term Safety and Efficacy of Deucravacitinib for Patients with Systemic Lupus Erythematosus

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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, also known by its code name BMS-986165. The study is specifically for individuals with Systemic Lupus Erythematosus (SLE), a chronic autoimmune disease where the immune system attacks the body's own tissues, causing inflammation and damage to various organs.

The purpose of the study is to understand how safe and tolerable deucravacitinib is for people with SLE over an extended period. Participants in the study will receive either a 3 mg, 6 mg, or 12 mg dose of deucravacitinib in the form of a film-coated tablet, or a placebo, which looks like the medication but does not contain the active ingredient. The medication is taken orally, meaning it is swallowed. The study will monitor participants for any side effects and assess how well the medication works in managing the symptoms of SLE.

Throughout the study, participants will have regular check-ups to track their health and any changes in their condition. The study aims to provide valuable information on the long-term use of deucravacitinib for treating Systemic Lupus Erythematosus, helping to determine its potential as a treatment option for this condition.

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

    Joining the study

    Upon joining the study, the participant must have completed a previous study and be currently receiving a study drug. In certain cases, exceptions may be made for those not currently receiving the drug due to specific circumstances.

    Women of childbearing potential must undergo a pregnancy test before starting the study drug and agree to use contraception during the study and for a specified period after the last dose.

  2. Step 2

    Medication administration

    The study involves the administration of deucravacitinib, which is taken orally in the form of film-coated tablets.

    The available dosages are 3 mg, 6 mg, and 12 mg tablets. A placebo tablet may also be used to match the appearance of the deucravacitinib tablets.

  3. Step 3

    Monitoring and assessments

    Throughout the study, participants will be monitored for any adverse events or serious adverse events. Vital signs and laboratory parameters will be regularly checked.

    The study will also assess the efficacy of the treatment through various measures, including joint counts, skin assessments, and other clinical responses.

  4. Step 4

    End of study

    The study is expected to conclude by March 31, 2025. Participants will continue to be monitored until the end of the study period.

    After the study, participants will be evaluated for any long-term effects of the treatment.

Who can join the trial?

8 criteria

  • The patient must have signed a written informed consent form, which means they agree to participate in the study after being informed about it.
  • The patient must have completed a previous study called IM011021 and be currently receiving a study drug that is not identified to them (blinded study drug). If the patient missed the study drug due to special situations like the COVID-19 pandemic, they might still join with approval from the study doctor.
  • For women who can have children, they must have a negative pregnancy test before starting the study drug. This test checks for a hormone called human chorionic gonadotropin (hCG) to ensure they are not pregnant.
  • Women must not be pregnant, breastfeeding, or planning to become pregnant during the study.
  • Women who can have children must agree to use effective birth control methods while taking the study drug and for a total of 33 days after the last dose. This is to prevent pregnancy during and shortly after the study.
  • Women who are not sexually active with men do not need to use birth control but still need to take pregnancy tests as required by the study.
  • Men who are sexually active with women who can have children must agree to use birth control methods during the study.
  • Men who cannot produce sperm (azoospermic) do not need to use birth control.

Who cannot join the trial?

10 criteria

  • Having any other serious health condition that could interfere with the study.
  • Being pregnant or planning to become pregnant during the study.
  • Currently breastfeeding.
  • Having a history of severe allergic reactions to medications.
  • Using certain medications that might interfere with the study treatment.
  • Having a recent history of drug or alcohol abuse.
  • Participating in another clinical trial at the same time.
  • Having an active infection that requires treatment.
  • Having a history of certain types of cancer.
  • Having a weakened immune system.
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Investigated drugs

BMS-986165 is a medication being studied for its long-term safety and effectiveness in people with systemic lupus erythematosus (SLE). This medication is being tested to see how well it can be tolerated by patients over an extended period and to understand its potential benefits in managing the symptoms of SLE.

What is already known about the treatment

BMS-986165 – This medication is administered orally and is currently being studied in clinical trials for its long-term safety and effectiveness in treating Systemic Lupus Erythematosus (SLE). It is not yet widely available in medical practice, as it is still under investigation. The main therapeutic use of BMS-986165 is to manage symptoms associated with SLE, an autoimmune disease. At the molecular level, it works by selectively inhibiting certain enzymes involved in the immune response, which helps reduce inflammation and immune system overactivity. It is classified pharmacologically as a selective tyrosine kinase 2 (TYK2) inhibitor.

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. SLE is characterized by periods of illness, called flares, and periods of wellness, or remission. The severity and symptoms of the disease can vary widely among individuals. Over time, SLE can lead to damage in the affected organs and tissues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502444-13-00Protocol codeIM011074Estimated enrolment261 patientsSponsorBristol Myers Squibb International Corporation

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