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Study on Baricitinib for Treating New-Onset Juvenile Dermatomyositis in Children

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What is this study about?

This clinical trial is focused on studying a condition called Juvenile Dermatomyositis, which is a rare inflammatory disease that affects the muscles and skin, primarily in children. The trial will explore the effectiveness of a medication known as Baricitinib, which is taken orally. Baricitinib is a chemical substance that may help reduce inflammation and improve symptoms in patients with this condition. The study aims to determine how well Baricitinib works in treating new cases of Juvenile Dermatomyositis over a period of 24 weeks.

Participants in the study will receive either Baricitinib or a placebo, and their progress will be monitored at various intervals, including weeks 4, 8, 12, 16, and 24. The main goal is to see if there is a 20% or greater improvement in the symptoms of Juvenile Dermatomyositis, such as muscle strength and skin condition, without significant worsening of any other symptoms. The study will also look at other levels of improvement and any changes in lung function, if applicable, as well as any side effects experienced by participants.

Throughout the study, various health markers will be measured, including certain proteins in the blood that are related to inflammation and immune response. Additionally, the study will examine the expression of genes related to immunity and assess muscle tissue samples to better understand the effects of Baricitinib. The trial is expected to conclude in June 2026, providing valuable insights into the potential benefits of Baricitinib for children with new-onset Juvenile Dermatomyositis.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age between 3-18 years, diagnosis of new-onset juvenile dermatomyositis, and muscle weakness.

Additional criteria include seropositivity or vaccination for chickenpox, and for those of childbearing age, a negative pregnancy test and use of effective contraception.

2 medication administration

The medication baricitinib is administered orally. The specific dosage and frequency are determined by the study protocol and are tailored to the patient’s needs.

The treatment duration is structured around a 24-week period, with regular monitoring and adjustments as necessary.

3 regular evaluations

Evaluations occur at weeks 4, 8, 12, 16, and 24 to assess improvement according to the PRINTO criteria. This involves measuring muscle strength and other health indicators.

Secondary assessments include monitoring for adverse events, changes in corticosteroid dosage, and various laboratory tests to evaluate disease activity and medication effects.

4 final assessment

At the end of the 24-week period, a comprehensive evaluation is conducted to determine the overall effectiveness of the treatment.

This includes a final assessment of muscle strength, disease activity, and any side effects experienced during the trial.

Who Can Join the Study?

  • Patient must be between 3 and 18 years old and have a new case of juvenile dermatomyositis, which is a condition that affects the muscles and skin.
  • Patient must have muscle weakness, which can be measured by tests called MMT (Manual Muscle Testing) and CMAS (Childhood Myositis Assessment Scale). The scores should be less than 74 for MMT and less than 45 for CMAS.
  • Patient must have either had chickenpox in the past or been vaccinated against it.
  • For patients who can have children (after starting menstruation), they must have a negative pregnancy test and use an effective method of birth control, such as not having sex, using hormonal birth control, an intrauterine device, or using a barrier method like a condom, until 7 days after the last dose of the study medication.
  • The patient or their parents must sign a form agreeing to participate in the study, which is called an informed consent form.
  • Patient must be part of a social security system, which means they have access to healthcare services.

Who Cannot Join the Study?

  • Patients who have a different condition than Juvenile Dermatomyositis cannot participate. This is a specific condition that affects muscles and skin in children.
  • Patients who are not within the age range specified for the study cannot participate. The study is for children, so adults are excluded.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients who have allergies or reactions to the study medication cannot participate.
  • Patients who are unable to provide consent or do not have a legal guardian to provide consent cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Ahpytkfiqm Pixzryva Hgtbahtz Du Mrhzcnxge Marseille France
Chntzd Hnexsivmqsi Raargimv Uugzrfinxtywb Dd Tyxzh Tours France
Cpls Dy Nijwv Vandoeuvre Les Nancy France
Hvwavsnd Udbdiaxcseqfdw Scdqshvdja &xnauri Hugvyru dc Hecqjbmtmju STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
10.11.2022

Trial locations

Investigated drugs:

Baricitinib is a medication being studied for its effectiveness in treating new-onset juvenile dermatomyositis, a condition that causes muscle inflammation and skin rash in children. The trial aims to see how well this medication works over a 24-week period.

Juvenile Dermatomyositis – This is a rare inflammatory disease that primarily affects children, causing muscle weakness and a distinctive skin rash. The condition involves inflammation of the muscles and skin, leading to symptoms such as muscle pain, fatigue, and difficulty with physical activities. The skin rash often appears as a purplish or reddish discoloration, typically on the eyelids and knuckles. Over time, the disease can lead to muscle atrophy and calcifications under the skin. The progression of symptoms can vary, with some children experiencing periods of remission and others having persistent symptoms. The exact cause of juvenile dermatomyositis is not well understood, but it is believed to involve an abnormal immune response.

Trial ID:
2024-513651-32-00
Protocol code:
APHP211036
NCT ID:
NCT05524311
Trial Phase:
Therapeutic exploratory (Phase II)

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