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

April 20, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Juvenile dermatomyositis (JDM) is a rare and severe paediatric-onset idiopathic inflammatory myopathy, associated with significant morbidity and mortality. The combination of corticosteroids and methotrexate (MTX) is recommended in new-onset JDM according to one randomized trial. However, in this trial, treatment failures were reported in 13/46 (28%) patients and severe JDM, (cutaneous or gastrointestinal ulceration, interstitial pulmonary disease, cardiomyopathy) were not taken into account. These data emphasize the need for a more efficient first-line treatment. Considering: 1) the strong implication of type IFN-I in the pathophysiology of JDM 2) the report of the efficacy and safety of JAK inhibitors (JAKis) (baricitinb, tofacitinib) in about 50 refractory DM patients, and 9 JDM, a trial which evaluates the efficacy and safety of baricitinib in combination with corticosteroids in new-onset JDM is warranted.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France
        • Hôpital Pellegrin
      • Bron, France
        • Hôpital Femme Mère Enfant
      • Lille, France
        • Hôpital Jeanne de Flandre
      • Marseille, France
        • Hôpital La Timone
      • Montpellier, France
        • Hôpital Villeneuce
      • Nancy, France
        • Hôpital Brabois
      • Paris, France
        • Hôpital Trousseau
      • Paris, France
        • Hôpital Robert Debré
      • Paris, France
        • Hopital Necker - Enfants malades : unité d'immuno-hématologie et rhumatologie
      • Paris, France
        • Hôpital du Kremlin-Bicêtre
      • Paris, France
        • Hôpital Necker - Enfants malades : service de dermatologie
      • Strasbourg, France
        • Hopital de Hautepierre
      • Toulouse, France
        • Hopital Purpan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 months to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 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 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 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 according to investigator appreciation, but necessarily, 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Baricitinib
Drug: Baricitinib
Oral tablets (2 mg) will be used For children > or = 6 years: 4 mg once a day (2 x 2 mg) during the 24 weeks-period study For children < 6 years: 2 mg once a day during the 24 weeks -period study
Biological: pharmacokinetics study
additionnal blood sampling at week 4, 8, 12, and 24
Biological: dosage of cytokines
additionnal blood sampling at weeks 0, 4 and 24
Biological: transcriptomic analysis
additionnal blood sampling at weeks 0, 4 and 24
Behavioral: Parent version of the Child Health Questionnaire (CHQ)
Evaluate by parents at each visits
Behavioral: Childhood Health Assessment Questionnaire
Evaluate by parents at each visits
Biological: Pregnancy test
Urine pregnancy test at V4 A dosage of bHCG with current biological analysis is done at each visit (except V4)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PRINTO 20 (Paediatric Rheumatology INternational Trials Organisation scale)
Time Frame: At week 24

Achievement of the validated juvenile dermatomyositis PRINTO 20 level of improvement. PRINTO 20 level of improvement is defined as a 20% or greater improvement in three or more of the six variables of the juvenile dermatomyositis core set, with one or no variable worsening by more than 30% (muscle strength can not be the variable worsening) :

  1. muscle strength, assessed with the Childhood Myositis Assessment Scale (CMAS),
  2. physician's global assessment of the patient's disease activity (Physician's VAS)
  3. global disease activity assessment through the Disease Activity Score (DAS)
  4. functional ability through the Childhood Health Assessment Questionnaire (C-HAQ)
  5. parent's global assessment of the child's overall wellbeing (Parent's VAS)
  6. health-related quality of life, through the parent version of the Child Health Questionnaire (CHQ-Phs) A higher score is 100% and means a better outcome, a lower score is 0% and means a worse result.
At week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PRINTO 20 Paediatric Rheumatology INternational Trials Organisation scale - level 20
Time Frame: At week 4, 8, 12 and 16
achievement of the validated juvenile dermatomyositis PRINTO 20 level ; reaching a minimum of 20 % a higher score is 100% and mean a better outcome a lower score is 0% and means a worse result
At week 4, 8, 12 and 16
PRINTO 50 Paediatric Rheumatology INternational Trials Organisation scale - level 50
Time Frame: At week 4, 8, 12 and 16
achievement of the validated juvenile dermatomyositis PRINTO 50 level ; reaching a minimum of 50 % a higher score is 100% and mean a better outcome a lower score is 0% and means a worse result
At week 4, 8, 12 and 16
PRINTO 70 Paediatric Rheumatology INternational Trials Organisation scale - level 70
Time Frame: At week 4, 8, 12 and 16
achievement of the validated juvenile dermatomyositis PRINTO 70 level ; reaching a minimum of 70 % a higher score is 100% and mean a better outcome a lower score is 0% and means a worse result
At week 4, 8, 12 and 16
PRINTO 90 Paediatric Rheumatology INternational Trials Organisation scale - level 90
Time Frame: At week 4, 8, 12 and 16
achievement of the validated juvenile dermatomyositis PRINTO 90 level ; reaching a minimum of 90 % a higher score is 100% and mean a better outcome a lower score is 0% and means a worse result
At week 4, 8, 12 and 16
Total Improvement Score (TIS)
Time Frame: At inclusion, weeks 4, 8, 12, 16 and 24
Relative and absolute variations of TIS. The TIS is the sum of the improvement in each of the six core set measures of disease activits The minimum score is 0 (worse) and maximum score is 100 (better) A major response is defined by a score > 70 A moderate response is defined by a score > 45 A minimal response is defined by a score > 30
At inclusion, weeks 4, 8, 12, 16 and 24
Clinically inactive disease
Time Frame: At weeks 4, 8, 12 and 24
according to the PRINTO criteria
At weeks 4, 8, 12 and 24
Cutaneous Dermatomyositis Disease Area and Severity Index (CDSAI)
Time Frame: At inclusion, weeks 4, 8, 12, 16 and 24
assess skin activity and damage across multiple body regions in patients with dermatomyositis
At inclusion, weeks 4, 8, 12, 16 and 24
Myositis Disease Activity Assessment VAS (MYOACT)
Time Frame: At inclusion, weeks 4, 8, 12, 16 and 24
Assess Relative and absolute variations of extramuscular activity
At inclusion, weeks 4, 8, 12, 16 and 24
interstitial lung disease
Time Frame: At inclusion and at week 24
Assessed by improvement of at least 10% of FCV, PTC, and DLCO and/or improvement of Lung tomodensitomery according to a specific scale
At inclusion and at week 24
Dose of corticosteroid
Time Frame: At week 24
Dose tapering at 6 months
At week 24
Pharmacokinetics study
Time Frame: At weeks 4, 8, 12, and 24
Non-compartmental analysis of baricitinib
At weeks 4, 8, 12, and 24
Pharmacokinetics (PK) study with area under the curve
Time Frame: At weeks 4, 8, 12, and 24
Correlation between area under the curve AUC in ng.h/ml (PK parameter of baricitinib) and disease activity 's scores
At weeks 4, 8, 12, and 24
Pharmacokinetics (PK) study with maximal concentration
Time Frame: At weeks 4, 8, 12, and 24
Correlation between maximal concentration Cmax in ng/mL (PK parameter of baricitinib) and disease activity 's scores
At weeks 4, 8, 12, and 24
Pharmacokinetics (PK) study with through concentration
Time Frame: At weeks 4, 8, 12, and 24
Correlation between through concentration Ctrough, in ng/mL (PK parameter of baricitinib) and disease activity 's scores
At weeks 4, 8, 12, and 24
dosage of cytokines
Time Frame: At inclusion, weeks 4 and 24
Measurement of serum IFN -, IFN-γ, IL-1β, IL-4, Il-5, IL-6, IL-8, IL-10, IL-12p70, IL-22, TNF α
At inclusion, weeks 4 and 24
transcriptomic analysis
Time Frame: At inclusion, weeks 4 and 24
Study of genes expression within 800 genes related to immunity
At inclusion, weeks 4 and 24
Biopsy
Time Frame: At inclusion, weeks 4 and 24
Assessment of muscle biopsies according to the internationally validated score system
At inclusion, weeks 4 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
URC-CIC Paris Descartes Necker Cochin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Cyril GITIAUX, Doctor, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 10, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 13, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 2, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APHP211036
  • 2022-000506-10 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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