Authorised Phase II and Phase III (Integrated) Dermatomyositis; Baricitinib in patients with relapsing or naïve dermatomyositis.

Baricitinib in patients with relapsing or naïve dermatomyositis (BIRD)

EU CTIS ID: 2024-511899-32-00

What this study is testing

to evaluate the efficacy of baricitinib (JAK1/2 inhibitor) to obtain prednisone-free DM moderate improvement as compared to placebo, in addition to usual care.

  • Phase II and Phase III (Integrated)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • - Adult subjects (≥ 18 years old) < 65 years old
  • - Dermatomyositis (DM) defined according to the 239th ENMC criteria: either naïve or non-naïve DM
  • - Active disease (ACR/EULAR criteria) defined as: • Manual Muscle Testing (MMT-8) <145/150 and at least two additional abnormal corset measurements (CSM): >3/10 cm on Visual Analogue Scale (VAS) of patient global, physician global and extra-muscular disease activity, Health Assessment Questionnaire Disability Index >0.25, or elevated muscle enzymes. • Or cutaneous CDASI > 20 and at least two additional abnormal corset measurements (CSM): >3/10 cm on Visual Analogue Scale (VAS) of patient global, physician global and extra-muscular disease activity, Health Assessment Questionnaire Disability Index >0.25, or elevated muscle enzymes
  • - for relapsing/non naïve DM patients o in case of corticosteroid exposure patient must receive a stable dose < 30 mg/d prednisone with or without additional immunosuppressive therapy for at least 4 weeks before the baseline visit. o Stable dose of immunosuppressive therapy for at least 3 months before
  • - Affiliation to a social security regime
  • - Written informed consent

You likely can't join if

  • - Life-threatening complications o Severe swallowing troubles defined as: food swallowed the wrong way and/or time to drink a glass of 200 ml water above 30 seconds related to DM o Interstitial lung disease related to the DM with one among the following complications (complications must be related to the ILD): dyspnea NYHA III, hypoxemia with PaO2≤65 mmHg, and/or DLCOc/Alveolar Volume ≤70% (pulmonary function test) o Symptomatic myocarditis o Loss of walking ability
  • - Contraindication to Methotrexate and/or Azathioprine including hypersensitivity to the active substances or to any of the excipients
  • - Conditions affecting the outcomes (Expected poor compliance)
  • - Patient with deep vein thrombosis/pulmonary embolism or antecedent
  • - Severe disease damages: e.g. muscle weakness mainly related to muscle damage such as fat replacement of muscle) defined as persistent changes in anatomy, physiology, pathology or function which result from previously active disease and from complications of therapy or other events (e.g.; muscle atrophy, fatty replacement; skin scars, poikiloderma). Severe disease damage is considered when the patient condition has no or minor ability to improve with the treatment.
  • -Significant uncontrolled cardiovascular, cerebrovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neuropsychiatric disorders, or abnormal laboratory values that developed during a qualifying study that, in the opinion of the investigator, poses an unacceptable risk for the patient’s participation
See the full eligibility criteria
Who can join
  • - Adult subjects (≥ 18 years old) < 65 years old
  • - Dermatomyositis (DM) defined according to the 239th ENMC criteria: either naïve or non-naïve DM
  • - Active disease (ACR/EULAR criteria) defined as: • Manual Muscle Testing (MMT-8) <145/150 and at least two additional abnormal corset measurements (CSM): >3/10 cm on Visual Analogue Scale (VAS) of patient global, physician global and extra-muscular disease activity, Health Assessment Questionnaire Disability Index >0.25, or elevated muscle enzymes. • Or cutaneous CDASI > 20 and at least two additional abnormal corset measurements (CSM): >3/10 cm on Visual Analogue Scale (VAS) of patient global, physician global and extra-muscular disease activity, Health Assessment Questionnaire Disability Index >0.25, or elevated muscle enzymes
  • - for relapsing/non naïve DM patients o in case of corticosteroid exposure patient must receive a stable dose < 30 mg/d prednisone with or without additional immunosuppressive therapy for at least 4 weeks before the baseline visit. o Stable dose of immunosuppressive therapy for at least 3 months before
  • - Affiliation to a social security regime
  • - Written informed consent
What rules you out
  • - Life-threatening complications o Severe swallowing troubles defined as: food swallowed the wrong way and/or time to drink a glass of 200 ml water above 30 seconds related to DM o Interstitial lung disease related to the DM with one among the following complications (complications must be related to the ILD): dyspnea NYHA III, hypoxemia with PaO2≤65 mmHg, and/or DLCOc/Alveolar Volume ≤70% (pulmonary function test) o Symptomatic myocarditis o Loss of walking ability
  • - Contraindication to Methotrexate and/or Azathioprine including hypersensitivity to the active substances or to any of the excipients
  • - Conditions affecting the outcomes (Expected poor compliance)
  • - Patient with deep vein thrombosis/pulmonary embolism or antecedent
  • - Severe disease damages: e.g. muscle weakness mainly related to muscle damage such as fat replacement of muscle) defined as persistent changes in anatomy, physiology, pathology or function which result from previously active disease and from complications of therapy or other events (e.g.; muscle atrophy, fatty replacement; skin scars, poikiloderma). Severe disease damage is considered when the patient condition has no or minor ability to improve with the treatment.
  • -Significant uncontrolled cardiovascular, cerebrovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neuropsychiatric disorders, or abnormal laboratory values that developed during a qualifying study that, in the opinion of the investigator, poses an unacceptable risk for the patient’s participation
  • - Chest imaging (CT scan or radiograph) showing abnormalities not related with the DM in the last 12 weeks judged by the investigator as clinically significant.-Participants included in other intervention research involving humans
  • - Patient under tutorship or guardianship, and incapable to give informed consent
  • - Patient with antecedent of cardiovascular event (myocardial infarction or ischemic stroke)
  • - Patient who is current or past long-time smoker
  • - Pregnant or lactating, or women planning to become pregnant or initiating breastfeeding
  • -Active severe infection including active hepatitis
  • - No effective contraception during the study and one week after for women of childbearing age
  • - Renal impairment defined as clearance < 60 ml
  • - Strong Organic Anion Transporter 3 (OAT3) inhibitors
  • - Active cancer or history of malignancy
  • -Participants included in other intervention research involving humans
  • - Evidence of latent tuberculosis (as documented by a positive QuantiFERON-TB Gold plus test)
  • - Absolute Neutrophil Count < 1x109 cells/L
  • - Haemoglobin (Hb) < 8 g/dL
  • - Severe hepatic impairment attested by FV (coagulation factor)<30%
  • - Liver insufficiency (Prothrombin time <60%)
  • - Previous treatment exposure defined as follows: • Rituximab treatment within 6 months before inclusion • IVIg, or cyclophosphamide infusion within the month before inclusion • • both methotrexate (0.3 mg/kg/w) and azathioprine exposure for at least 3 months each and at the 0.3 mg/kg/w and 2-3 mg/kg/d dosages respectively with failure of both (but exposure and/or failure to either of these two drugs alone is not an exclusion criterion) • for naïve DM patients only more than 2 weeks treatment duration with corticosteroids at the dose of 1 mg/kg/d before the inclusion.
  • - Hypersensitivity to the active substance (baricitinib) or to any of the excipients

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.