Study on Baricitinib for Patients with Relapsing or Naïve Dermatomyositis

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Centre Jean Perrin	Clermont Ferrand	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Cftofz Hyykvcjmghz Uuhxfxneqiutv Rfmpt	Reims	France
Cyf dvrobskmlvftwl	Epagny Metz Tessy	France
Cyhzor Hmmsawtpywu Uidysrigwqrds Dn Douwd	Dijon	France
Amzdhpubgn Pdqcatzc Hovobvkg Dn Mylqbashb	Marseille	France
Hmuouwxs Uvfqsyiwnvykwc Sukgogonwz &bhbdkj Hknjnil da Hduehezujxw	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	31.08.2022

Trial locations

Investigated drugs:

Baricitinib

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.

Investigated diseases:

Dermatomyositis

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 ID:

2024-511899-32-00

Protocol code:

APHP180612

NCT ID:

NCT04972760

Trial Phase:

Therapeutic use (Phase IV)

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Study on Baricitinib for Patients with Relapsing or Naïve Dermatomyositis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?