Baricitinib in the Treatment of New-onset Juvenile Dermatomyositis (MYOCIT)

• Status: Not yet recruiting
• Trial end date: 2026-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The MYOCIT study aims to evaluate the efficacy and safety of baricitinib in association with corticosteroids in new-onset patients with juvenile dermatomyositis (JDM) in a phase II trial with the objective to obtain a better efficacy than the conventional combination methotrexate (MTX) and corticosteroids over the 24 week study period. Thus, the investigators hypothesize that baricitinib could be used as a first line treatment in all forms of DMJ, including the most severe one, with a good safety profile.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Criteria

Inclusion Criteria:

• Patient aged 3-18 years with new-onset juvenile dermatomyositis, according to the ENMC 2018 dermatomyositis classification criteria

• Muscle weakness at MMT and/or CMAS (MMT < 74 and/or CMAS < 45)

• Seropositivity for chickenpox

• For patients of childbearing age (following menarche) : Negative βHCG and effective method of contraception (sexual abstinence, hormonal contraception, intrauterine device or hormone-releasing system, cap, diaphragm or sponge with spermicide, condom) until the 7 days after administration of the last dose of Baricitinib

• Informed consent form signed by the patient or child' s parents Patient affiliated to a social security regime

Exclusion Criteria

• Amyopathic dermatomyositis (without muscle weakness)

• Inability to be treated by oral way or to take pills

• Previous treatment with JAK inhibitor

• Previous treatment of JDM with immunosuppressive drugs or biologics other than corticosteroids. Previous treatment with prednisone was allowed if the daily dose was greater than 1 mg/kg for no more than 1 month.

• Previous history of cancer

• Live vaccine within the 4 weeks before starting baricitinib therapy

• Current, or recent (< 4 weeks prior to baseline) of active infections, including HBV, HCV, HIV, tuberculosis,

• Positive blood CMV PCR

• Creatinine clearance < 40 ml/min

• Lymphocytes < 0,5x109 cell/L and Neutrophils < 1x109 cell/L

• Hemoglobin < 8 g/dL

• Symptomatic herpes herpes simplex infection within 12 weeks prior to inclusion

• Positivity for antiphospholipids antibodies (Lupus anticoagulant and/or anti-beta2 glycoprotein 1 and/or anti-cardiolipin)

• History of thrombosis or considered at high risk of venous thrombosis by the investigator

• Presence of severe JDM-related involvements: cardiovascular (requiring vasopressive drug and/or intensive care unit), respiratory (requiring oxygen and/or intensive care unit), gastrointestinal (requiring abdominal surgery).

• History of severe non-related JDM involvement: cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological or neuropsychiatric disorders or any other serious and/or instable illness that, in the opinion of the investigator, could constitute an unacceptable risk, when taking baricitinib.

• Actual or in project of pregrancy and breast-feeding until the 7 days after administration of the last dose of Baricitinib

• Patient on AME (state medical aid)

• Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants