Actively Recruiting
Baricitinib in Patients With Relapsing or Naïve Dermatomyositis: a Multicenter Randomized Controlled Trial (BIRD)
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-06-02
62
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Dermatomyositis (DM) is a rare and disabling condition that can severely affect quality of life and may lead to life-threatening complications. Current treatments rely on high doses of corticosteroids, which can cause serious side effects and are linked to disease relapses when tapered. This trial evaluates the addition of baricitinib, a Janus kinase 1 and 2 (JAK1/2) inhibitor, to usual care to improve DM symptoms while reducing the need for corticosteroids. The study is a multicenter, phase III, double-blind, randomized placebo-controlled trial conducted across hospitals in France. Participants are randomly assigned to one of two groups: one group receives baricitinib along with a prednisone taper and an immunosuppressive drug (either methotrexate or azathioprine), and the other group receives a placebo plus the same prednisone taper and immunosuppressive drug. Treatment lasts for 24 weeks, during which corticosteroids are gradually reduced according to a predefined protocol. This add-on approach aims to compare the effect of baricitinib versus placebo in achieving moderate improvement in DM without the use of prednisone. Throughout the study, participants will attend five visits: screening, baseline, two follow-ups at weeks 5 and 12, and an end-of-study visit at week 24. Researchers will collect data electronically, monitoring disease improvement, corticosteroid use, skin activity, relapse rates, and adverse events. The primary outcome is the rate of moderate improvement without prednisone at 24 weeks. This trial aims to enroll 62 patients aged 18 to 64 years with active DM, and all assessments and treatments are supervised by medical professionals.
CONDITIONS
Brief Title
Baricitinib in Patients With Relapsing or naïve Dermatomyositis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to less than 65 years
- Diagnosis of dermatomyositis according to the 239th ENMC criteria, either new or relapsing
- Active disease defined by specific muscle testing and symptom scores or a high cutaneous disease activity score with additional abnormal assessments
- For relapsing patients, stable corticosteroid dose under 30 mg/day for at least 4 weeks before baseline
- Stable immunosuppressive therapy dose for at least 3 months before baseline
- Affiliated to a social security regime
- Signed written informed consent
You will not qualify if you...
- Severe swallowing difficulties related to dermatomyositis
- Interstitial lung disease with severe respiratory complications
- Symptomatic myocarditis or loss of walking ability
- History of deep vein thrombosis or pulmonary embolism
- History of myocardial infarction or ischemic stroke
- Current or past long-term smoking
- Pregnant, breastfeeding, or planning pregnancy without effective contraception
- Renal impairment with clearance less than 60 ml
- Use of strong OAT3 inhibitors
- Active cancer or history of malignancy
- Active severe infections including hepatitis
- Evidence of latent tuberculosis
- Very low neutrophil count or haemoglobin below 8 g/dL
- Severe liver impairment or coagulation abnormalities
- Recent treatment with rituximab, IVIg, or cyclophosphamide
- Previous failure of both methotrexate and azathioprine at specified doses
- For new patients, corticosteroid treatment longer than 2 weeks at high dose before inclusion
- Hypersensitivity to baricitinib or excipients
- Contraindications or hypersensitivity to methotrexate or azathioprine
- Conditions expected to reduce compliance
- Severe permanent muscle or skin damage unlikely to improve
- Significant uncontrolled medical disorders posing risk
- Chest imaging abnormalities unrelated to dermatomyositis judged significant
- Participation in other human intervention research
- Under guardianship or unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive baricitinib or placebo plus prednisone taper and one immunosuppressive drug (either methotrexate or azathioprine) for 24 weeks.
1 baseline visit and 3 follow-up visits over 24 weeks
Trial Site Locations
Total: 1 location
1
Pitie-Salpêtrière hospital APHP
Paris, France, 75013
Actively Recruiting
Research Team
Y
YVES ALLENBACH, MD, PhD
S
SARRA POCHON
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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