Baricitinib in the Treatment of New-onset Juvenile Dermatomyositis (MYOCIT)
Key facts
- Phase
- Phase 2
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
Trial details
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT05524311EU 2024-513651-32-00
- Record updated
- 23 April 2026
- Original description
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.Read full original descriptionShow less
Baricitinib in the Treatment of New-onset Juvenile Dermatomyositis
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.
Inclusion: 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 or vaccination 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: Previous treatment with JAK inhibitor; Previous treatment of JDM with immunosuppressive drugs or biologics other than corticosteroids. Previous treatment with prednisone was allowed for no more than 1 month; Live vaccine within the 4 weeks before starting baricitinib therapy; Current, or recent (< 4 weeks prior to baseline) of active infections according to investigator appreciation, but necessarily, including HBV, HCV, HIV, tuberculosis; Symptomatic herpes herpes simplex infection within 12 weeks prior to inclusion; 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); Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants; Previous history of cancer; History of thrombosis or considered at high risk of venous thrombosis by the investigator; 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; Creatinine clearance < 40 ml/min; Lymphocytes < 0,5x109 cell/L and Neutrophils < 1x109 cell/L; Hemoglobin < 8 g/dL; Amyopathic dermatomyositis (without muscle weakness); Inability to be treated by oral way or to take pills; Positive blood CMV PCR; 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).