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Study on the Effectiveness and Safety of Deucravacitinib for Adults with Active Sjogren's Syndrome

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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 in adults with a condition known as Sjögren's syndrome. Sjögren's syndrome is an autoimmune disease, which means the body's immune system mistakenly attacks its own cells, leading to symptoms like dry eyes and mouth. The study will use deucravacitinib in two different doses, 3 mg and 6 mg, in the form of film-coated tablets taken orally. Some participants will receive a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to evaluate how effective and safe deucravacitinib is for treating active Sjögren's syndrome. Participants will be randomly assigned to receive either the medication or a placebo. The study will last for about a year, during which participants will have regular check-ups to monitor their health and any changes in their symptoms. The main goal is to see if there is an improvement in the disease activity after 52 weeks of treatment.

Throughout the study, participants will be closely monitored for any side effects or changes in their condition. The study aims to provide valuable information on whether deucravacitinib can be a beneficial treatment option for people with Sjögren's syndrome. This research could potentially lead to new ways to manage the symptoms and improve the quality of life for those affected by 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, participants will be randomly assigned to receive either the medication deucravacitinib or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo.

  2. Step 2

    Medication administration

    Participants will take the assigned medication orally. The options include deucravacitinib in doses of 3 mg or 6 mg, or a placebo, all in the form of film-coated tablets.

    The medication will be taken as prescribed by the study protocol, which will specify the exact dosage and frequency.

  3. Step 3

    Monitoring and assessments

    Throughout the study, participants will undergo regular assessments to monitor the effectiveness and safety of the treatment. These assessments will include measuring changes in the ESSDAI (a disease activity index for Sjögren's syndrome) at various intervals, including Week 24 and Week 52.

    Additional assessments will evaluate changes in symptoms such as fatigue, dryness, and joint/muscle pain, as well as any side effects or adverse events.

  4. Step 4

    Completion of the study

    The study is expected to last until November 2028, with the primary objective being the comparison of the efficacy of deucravacitinib versus placebo by measuring improvements in the ESSDAI at Week 52.

    Upon completion, participants will have contributed valuable data to help understand the potential benefits and risks of deucravacitinib for treating active Sjögren's syndrome.

Who can join the trial?

6 criteria

  • Participants must be adults, which means they should be at least 18 years old or the age considered an adult in their country.
  • Participants need to meet the 2016 criteria set by the American College of Rheumatology and the European League Against Rheumatism for a condition called Sjogren's syndrome.
  • Participants should have moderate to severe Sjogren's syndrome, which is measured by a score called ESSDAI that should be 5 or higher.
  • Participants must test positive for a specific antibody known as anti-SSA/Ro antibody.
  • The condition should have been present for a short time, meaning 10 years or less.
  • Participants need to have a salivary flow rate of at least 0.05 mL per minute. This measures how much saliva is produced.

Who cannot join the trial?

10 criteria

  • Participants who have any other serious health condition that could interfere with the study.
  • Individuals who are currently pregnant or breastfeeding.
  • People who have had a recent infection that required treatment with antibiotics or antiviral medications.
  • Participants who have received any other investigational drug within a certain period before the study.
  • Individuals with a history of allergic reactions to similar medications.
  • People who have been diagnosed with cancer within the last five years, except for certain types of skin cancer.
  • Participants who have a history of drug or alcohol abuse.
  • Individuals who have received a live vaccine within a certain period before the study.
  • People who have a history of certain blood disorders.
  • Participants who have had a major surgery within a certain period before the study.
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Investigated drugs

Deucravacitinib is a medication being studied for its potential to help people with active Sjögren’s Syndrome. This condition is an autoimmune disorder that primarily affects the glands that produce tears and saliva, leading to dry mouth and eyes. The trial aims to see if this medication can improve symptoms by reducing inflammation and other related issues.

What is already known about the treatment

Deucravacitinib – Deucravacitinib is administered orally and is currently being studied in a Phase 3 clinical trial for its effectiveness in treating Sjogren's syndrome, an autoimmune condition. The medication is classified as a selective tyrosine kinase 2 (TYK2) inhibitor, which works by blocking specific pathways involved in the inflammatory process, thereby reducing symptoms associated with the disease. It is being evaluated for its ability to improve disease activity scores in patients over a 52-week period.

Investigated diseases

Sjogren's syndrome – Sjogren's syndrome is an autoimmune disorder characterized by the body's immune system mistakenly attacking its own moisture-producing glands. This leads to symptoms such as dry eyes and dry mouth, as the glands responsible for producing tears and saliva are affected. Over time, the condition can also impact other parts of the body, including the joints, skin, and organs like the kidneys and liver. The progression of the disease varies among individuals, with some experiencing mild symptoms and others facing more severe complications. It is a chronic condition, meaning it persists over a long period, and symptoms can fluctuate in intensity. The exact cause of Sjogren's syndrome is not fully understood, but it is believed to involve a combination of genetic and environmental factors.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503327-26-00Protocol codeIM011-1069Estimated enrolment755 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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