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Study on Baricitinib for Patients with Relapsing or Naïve Dermatomyositis

Verified siteRegistered drugNo 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 effects of a medication called Baricitinib in patients with a condition known as Dermatomyositis. Dermatomyositis is a rare inflammatory disease that causes muscle weakness and skin rashes. The study will compare the effectiveness of Baricitinib, which is a type of medication known as a JAK1/2 inhibitor, to a placebo. The goal is to see if Baricitinib can help improve the condition without the need for prednisone, a common steroid treatment, while patients continue their usual care.

Participants in the study will receive either Baricitinib or a placebo in the form of film-coated tablets. The study will last for a period of 24 weeks, during which the participants' progress will be monitored. The main focus is to observe moderate improvement in the condition without the use of corticosteroids like prednisone. The study will also look at other aspects such as the improvement of muscle strength and skin condition, the occurrence of relapses, and the overall safety of the treatment.

The study aims to provide valuable information on whether Baricitinib can be an effective treatment option for people with Dermatomyositis, potentially reducing the need for steroids and improving the quality of life for those affected by this condition. Participants will be closely monitored throughout the study to ensure their safety and to gather comprehensive data on the treatment's effects.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of dermatomyositis, and current treatment regimen.

    Eligibility criteria include being between 18 and 65 years old, having active dermatomyositis, and meeting specific health assessment criteria.

  2. Step 2

    Baseline visit

    A baseline visit is scheduled to establish a starting point for the study. This involves detailed health evaluations and documentation of current symptoms and treatments.

    Participants must have a stable dose of any current immunosuppressive therapy for at least three months prior to this visit.

  3. Step 3

    Medication administration

    Participants are randomly assigned to receive either Olumiant 4 mg film-coated tablets or a placebo. The medication is taken orally.

    The goal is to evaluate the effectiveness of baricitinib in achieving improvement without the use of corticosteroids.

  4. Step 4

    Follow-up assessments

    Follow-up assessments occur at weeks 5, 12, and 24 to monitor progress and evaluate improvement in symptoms.

    Improvement is measured using specific criteria, including muscle strength and skin condition assessments.

  5. Step 5

    Primary endpoint evaluation

    At week 24, the primary endpoint is evaluated. This involves assessing whether there has been a moderate improvement in symptoms without the use of corticosteroids.

    The improvement is defined as a total improvement score of 40 or more, according to established criteria.

  6. Step 6

    Secondary endpoint evaluation

    Secondary endpoints include various measures of improvement at weeks 5, 12, and 24, as well as the evaluation of safety and any adverse events.

    Additional assessments include the cumulative incidence of relapse and the average dose of prednisone during the study period.

  7. Step 7

    Study completion

    The study is estimated to conclude by March 31, 2026. Participants will have completed all assessments and medication regimens by this time.

    Final evaluations will be conducted to summarize the outcomes and effectiveness of the treatment.

Who can join the trial?

7 criteria

  • Must be an adult between 18 and 64 years old.
  • Must have a condition called Dermatomyositis (DM), which is a type of muscle disease. It can be either new (naïve) or previously diagnosed (non-naïve).
  • Must have active disease, meaning the condition is currently affecting you. This is determined by certain tests and measurements, such as muscle strength tests and other health assessments.
  • If you have relapsing or non-naïve DM and have been taking corticosteroids (a type of medication), you must be on a stable dose of less than 30 mg per day of a medication called prednisone, with or without other immune system medications, for at least 4 weeks before starting the study.
  • Must have a stable dose of any other immune system medications for at least 3 months before starting the study.
  • Must be part of a social security system.
  • Must provide written consent to participate in the study.

Who cannot join the trial?

5 criteria

  • Patients who have a different condition than **dermatomyositis**. Dermatomyositis is a disease that causes muscle weakness and skin rash.
  • Patients who are not experiencing a relapse or are not new to treatment for dermatomyositis.
  • Patients who are not able to stop using **prednisone**. Prednisone is a medication used to reduce inflammation.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Baricitinib is a medication being studied for its effectiveness in treating patients with dermatomyositis, a condition that causes muscle inflammation and skin rashes. It works by inhibiting certain enzymes known as JAK1 and JAK2, which are involved in the inflammatory process. The goal of using baricitinib in this trial is to see if it can help improve symptoms of dermatomyositis without the need for prednisone, a common steroid treatment.

What is already known about the treatment

Baricitinib – Baricitinib is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating dermatomyositis, particularly in patients who are either relapsing or have not previously been treated. The main therapeutic indication for baricitinib in this context is to achieve improvement in dermatomyositis symptoms without the need for prednisone, a common steroid treatment. At the molecular level, baricitinib works by inhibiting Janus kinase 1 and 2 (JAK1/2), which are enzymes involved in the inflammatory process. It is classified pharmacologically as a JAK inhibitor.

Investigated diseases

Dermatomyositis – Dermatomyositis is an inflammatory disease characterized by muscle weakness and a distinctive skin rash. It primarily affects the muscles and skin, leading to symptoms such as muscle pain, fatigue, and difficulty with physical activities. The skin rash often appears as a violet or dusky red discoloration, typically on the face, knuckles, and other areas exposed to sunlight. Over time, the muscle weakness can progress, affecting the ability to perform everyday tasks. The condition can vary in severity, with some individuals experiencing mild symptoms and others facing more significant challenges. It is considered a rare disease and can affect both adults and children.
Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-511899-32-00Protocol codeAPHP180612Estimated enrolment62 patientsSponsorAssistance Publique Hopitaux De Paris

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.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).