DermatomyositisPhase 3BIRDNCT04972760
Baricitinib in Patients With Relapsing or naïve Dermatomyositis
A Phase 3 study testing Baricitinib in people with Dermatomyositis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Dermatomyositis (DM) is a rare and disabling condition with an important impairment of quality of life and possible life-threatening complications. Treatment is based on high doses of corticosteroids but this exposes patients to adverse events (cardiovascular mortality, glucocorticoids-induced muscle and skin… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Dermatomyositis
- What is being tested?
- Baricitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 31 Aug 2022to 28 Feb 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult subjects (≥ 18 years old) < 65 years old
- Dermatomyositis 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 :
Show all 10Show fewer
- 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.
- Stable dose of immunosuppressive therapy for at least 3 months before
- Affiliation to a social security regime
- Written informed consent
Who cannot join
- Life-threatening complications :
- 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.
- 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)
- Symptomatic myocarditis o Loss of walking ability
- Patient with deep vein thrombosis/pulmonary embolism or antecedent
- Patient with antecedent of cardiovascular event (myocardial infarction or ischemic stroke)
Show all 30Show fewer
- Patient who is current or past long-time smoker
- Pregnant or lactating, or women planning to become pregnant or initiating breastfeeding
- 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
- Active severe infection including active hepatitis
- 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 follow : • Rituximab treatment within 6months 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
- 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)
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Pitie-Salpêtrière hospital APHP
Paris, 75013
SARRA POCHON, 00 33 1 42 16 75 74, sarra.pochon@aphp.fr
About this study
Official title: Baricitinib in Patients With Relapsing or naïve Dermatomyositis: a Multicenter Randomized Controlled Trial (BIRD)
Dermatomyositis (DM) is a rare and disabling condition with an important impairment of quality of life and possible life-threatening complications.
Treatment is based on high doses of corticosteroids but this exposes patients to adverse events (cardiovascular mortality, glucocorticoids-induced muscle and skin damages). Corticosteroids taper is associated with disease relapses. Although there is no evidence from the literature, clinical practice guidelines recommends the use of DMARDs such as methotrexate. However, response is not complete and these DMARDS take time to act.
Read more
The interferon type I (IFN-I) pathway is involved in the pathophysiology of DM. Janus kinase 1 and 2 transduces IFN-I signals. In addition, JAK2 inhibition enhances muscle repair and force generation.
JAK 1/2 inhibitors permitted to dramatically and rapidly improve relapsing DM patients (n=4, case series).
Our hypothesis is that Janus kinase 1 and 2 (JAK1/2) inhibitors (baricitinib) will permit to obtain dermatomyositis (DM) improvement with a steroid sparing effect as compared to usual care.
Our primary objective is to evaluate the efficacy of baricitinib (JAK1/2 inhibitor) to obtain prednisone-free moderate improvement (ACR/EULAR ≥ 40) of DM as compared to placebo in addition to usual care.
BIRD is a multicenter phase III double blind randomized placebo-controlled trial with two parallel arms (1:1). This is an add-on trial to usual care with rapid corticoid taper.
This is a multicenter trial in different medical departments in hospitals across France in different regions.
Out- and in patients will be recruited in hospital departments involved in management and diagnosis of DM: departments of dermatology, rheumatology and internal medicine.
Read the detailed description
Dermatomyositis (DM) is a rare and disabling condition with an important impairment of quality of life and possible life-threatening complications.
Treatment is based on high doses of corticosteroids but this exposes patients to adverse events (cardiovascular mortality, glucocorticoids-induced muscle and skin damages). Corticosteroids taper is associated with disease relapses. Although there is no evidence from the literature, clinical practice guidelines recommends the use of DMARDs such as methotrexate. However, response is not complete and these DMARDS take time to act.The interferon type I (IFN-I) pathway is involved in the pathophysiology of DM. Janus kinase 1 and 2 transduces IFN-I signals. In addition, JAK2 inhibition enhances muscle repair and force generation .
JAK 1/2 inhibitors permitted to dramatically and rapidly improve relapsing DM patients (n=4, case series) .
BIRD is a multicenter phase III double blind randomized placebo-controlled trial with two parallel arms (1:1). This is an add-on trial to usual care with rapid corticoid taper. Both groups (experimental and control groups) will receive corticosteroids and the conventional immunosuppressive drug (either azathioprine or methotrexate)
Our primary objective is 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.
Primary endpoint: moderate improvement (defined as a total improvement score superior or equal to 40 following ACR/EULAR definition) without corticosteroids at week 24 (prednisone-free moderate improvement).
This multicenter trial involves different medical departments in hospitals across France in different regions. Out- and in patients will be recruited in hospital departments involved in management and diagnosis of DM: departments of dermatology, rheumatology and internal medicine.
Eligible patients will sign a written informed consent after full oral and written information about the trial. They will be randomized in 1:1 ratio to receive baricitinib plus prednisone taper plus one immunosuppressive drug (either methotrexate or azathioprine) (experimental group) or placebo plus prednisone taper plus one immunosuppressive drug (either methotrexate or azathioprine) (control group) for a duration of 24 weeks. In both groups, corticosteroids are tapered following a predefined protocol.
5 visits are planned:
- screening visit (W-4 to D-1)
- baseline visit (W0)
- follow-up visit 1 (W5 +/-5 days)
- follow-up visit 2 (W12 +/-5 days)
- end of study visit 3 (W24+/-5 days) Data will be collected by investigator and clinical research associate on an electronic case report form (eCRF) via a web browser.
The primary analysis will be the comparison between experimental and control groups of the rate of prednisone-free moderate improvement at 24 weeks in the intent to treat population. In order to demonstrate a difference in the rate of primary outcome at 24 weeks from 30% in the control group to 70% in the experimental group, with a power of 80%, a bilateral alpha risk of 5%, and a 15% rate of loss of follow-up, 62 patients are necessary.
- Conditions
- Dermatomyositis
- Being tested
- Baricitinib, Placebo
- Keywords
- Dermatomyositis, baricitinib, steroid sparing
- Medical subject headings
- Dermatomyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaricitinibDrug
Baricitinib, 4 mg/d, oral route for 24 weeks
PlaceboDrug
Placebo, 4 mg/d, oral route for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| baricitinib arm | Experimental | Patients receive baricitinib plus prednisone taper plus one immunosuppressive drug (either methotrexate or azathioprine) for a duration of 24 weeks. Corticosteroids are tapered following a predefined protocol. Receives: Drug: Baricitinib |
| placebo arm | Placebo comparator | Patients receive placebo plus prednisone taper plus one immunosuppressive drug (either methotrexate or azathioprine) for a duration of 24 weeks. Corticosteroids are tapered following a predefined protocol. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate improvement at 24 weeks without prednisone: prednisone-free moderate improvement.
The rate of patients with a moderate improvement at 24 weeks, defined as a total improvement score superior or equal to 40 following ACR/EULAR definition. The investigator will consider that patients following the planned prednisone tapering scheme (corticosteroids 0 mg/d at W24) will be prednisone-free.
Measured: 24 weeks
Secondary outcomes (9)
Dermatomyositis minimal improvement
The rate of patients with a minimal improvement, defined as a total improvement score ≥20 points (ACR/EULAR definition)
Measured: 5, 12 and 24 weeks
Dermatomyositis moderate improvement
The rate of patients with a moderate improvement, defined as a total improvement score ≥40 points (ACR/EULAR definition)
Measured: 5, 12 and 24 weeks
Dermatomyositis major improvement
The rate of patients with a major improvement, defined as a total improvement score ≥60 points (ACR/EULAR definition)
Measured: 5, 12 and 24 weeks
Primary endpoint prednisone-free moderate improvement at Weeks 24 in subgroups
- DM naive patients at baseline vs others
- DM with a severe muscle weakness (MMT8 baseline <125/150) vs others
Measured: 24 weeks
Cutaneous disease activity and damage
Cutaneous disease activity and damage evaluated using the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) - Activity and CDASI damages (from 0 to 48, 48 is the maximum disease severity)
Measured: 5, 12 and 24 weeks
Cumulative incidence of relapse
Cumulative incidence of relapse with the time to first relapse
Measured: up to 24 weeks
Cumulative dose of corticosteroids
Cumulative dose of corticosteroids at 24 weeks
Measured: 24 weeks
Average prednisone dose per day through the last 4 weeks (0 mg per day, of more than 0 mg to not more than 4.0 mg per day, of more than 4.0 mg to not more than 7.5 mg per day, and of more than 7.5 mg per day).
Proportion of participants with an average prednisone dose of 0 mg per day, of more than 0 mg to not more than 4.0 mg per day, of more than 4.0 mg to not more than 7.5 mg per day, and of more than 7.5 mg per day through the last 4 weeks.
Measured: 24 weeks
Adverse events
Incidence, nature, and severity of adverse events and serious adverse events and laboratory abnormalities
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start31 Aug 2022
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatomyositisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YVES ALLENBACH, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972760
- Sponsor's protocol ID
- APHP180612
- Other IDs
- 2024-511899-32-00, 2020-004987-24
- Acronym
- BIRD
- Status last verified
- May 2026
- First submitted
- 14 Jun 2021
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baricitinib in Patients With Relapsing or naïve Dermatomyositis: a Multicenter Randomized Controlled Trial (BIRD)
- ClinicalTrials.gov ID
- NCT04972760
- Acronym / sponsor ID
- BIRD / APHP180612
- Conditions
- Dermatomyositis
- Keywords
- Dermatomyositis, baricitinib, steroid sparing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dermatomyositis (DM) is a rare and disabling condition with an important impairment of quality of life and possible life-threatening complications.
Treatment is based on high doses of corticosteroids but this exposes patients to adverse events (cardiovascular mortality, glucocorticoids-induced muscle and skin damages). Corticosteroids taper is associated with disease relapses. Although there is no evidence from the literature, clinical practice guidelines recommends the use of DMARDs such as methotrexate. However, response is not complete and these DMARDS take time to act.
The interferon type I (IFN-I) pathway is involved in the pathophysiology of DM. Janus kinase 1 and 2 transduces IFN-I signals. In addition, JAK2 inhibition enhances muscle repair and force generation.
JAK 1/2 inhibitors permitted to dramatically and rapidly improve relapsing DM patients (n=4, case series).
Our hypothesis is that Janus kinase 1 and 2 (JAK1/2) inhibitors (baricitinib) will permit to obtain dermatomyositis (DM) improvement with a steroid sparing effect as compared to usual care.
Our primary objective is to evaluate the efficacy of baricitinib (JAK1/2 inhibitor) to obtain prednisone-free moderate improvement (ACR/EULAR ≥ 40) of DM as compared to placebo in addition to usual care.
BIRD is a multicenter phase III double blind randomized placebo-controlled trial with two parallel arms (1:1). This is an add-on trial to usual care with rapid corticoid taper.
This is a multicenter trial in different medical departments in hospitals across France in different regions.
Out- and in patients will be recruited in hospital departments involved in management and diagnosis of DM: departments of dermatology, rheumatology and internal medicine.
Detailed description
Dermatomyositis (DM) is a rare and disabling condition with an important impairment of quality of life and possible life-threatening complications.
Treatment is based on high doses of corticosteroids but this exposes patients to adverse events (cardiovascular mortality, glucocorticoids-induced muscle and skin damages). Corticosteroids taper is associated with disease relapses. Although there is no evidence from the literature, clinical practice guidelines recommends the use of DMARDs such as methotrexate. However, response is not complete and these DMARDS take time to act.The interferon type I (IFN-I) pathway is involved in the pathophysiology of DM. Janus kinase 1 and 2 transduces IFN-I signals. In addition, JAK2 inhibition enhances muscle repair and force generation .
JAK 1/2 inhibitors permitted to dramatically and rapidly improve relapsing DM patients (n=4, case series) .
BIRD is a multicenter phase III double blind randomized placebo-controlled trial with two parallel arms (1:1). This is an add-on trial to usual care with rapid corticoid taper. Both groups (experimental and control groups) will receive corticosteroids and the conventional immunosuppressive drug (either azathioprine or methotrexate)
Our primary objective is 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.
Primary endpoint: moderate improvement (defined as a total improvement score superior or equal to 40 following ACR/EULAR definition) without corticosteroids at week 24 (prednisone-free moderate improvement).
This multicenter trial involves different medical departments in hospitals across France in different regions. Out- and in patients will be recruited in hospital departments involved in management and diagnosis of DM: departments of dermatology, rheumatology and internal medicine.
Eligible patients will sign a written informed consent after full oral and written information about the trial. They will be randomized in 1:1 ratio to receive baricitinib plus prednisone taper plus one immunosuppressive drug (either methotrexate or azathioprine) (experimental group) or placebo plus prednisone taper plus one immunosuppressive drug (either methotrexate or azathioprine) (control group) for a duration of 24 weeks. In both groups, corticosteroids are tapered following a predefined protocol.
5 visits are planned:
- screening visit (W-4 to D-1)
- baseline visit (W0)
- follow-up visit 1 (W5 +/-5 days)
- follow-up visit 2 (W12 +/-5 days)
- end of study visit 3 (W24+/-5 days) Data will be collected by investigator and clinical research associate on an electronic case report form (eCRF) via a web browser.
The primary analysis will be the comparison between experimental and control groups of the rate of prednisone-free moderate improvement at 24 weeks in the intent to treat population. In order to demonstrate a difference in the rate of primary outcome at 24 weeks from 30% in the control group to 70% in the experimental group, with a power of 80%, a bilateral alpha risk of 5%, and a 15% rate of loss of follow-up, 62 patients are necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| baricitinib arm | Experimental | Drug: BaricitinibPatients receive baricitinib plus prednisone taper plus one immunosuppressive drug (either methotrexate or azathioprine) for a duration of 24 weeks. Corticosteroids are tapered following a predefined protocol. |
| placebo arm | Placebo comparator | Drug: PlaceboPatients receive placebo plus prednisone taper plus one immunosuppressive drug (either methotrexate or azathioprine) for a duration of 24 weeks. Corticosteroids are tapered following a predefined protocol. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Adult subjects (≥ 18 years old) < 65 years old
- Dermatomyositis defined according to the 239th ENMC criteria either naïve or non-naïve DM
- Active disease (ACR/EULAR criteria) defined as :
- for relapsing/non naïve DM patients :
- Affiliation to a social security regime
Key exclusion criteria (30 listed)
- Life-threatening complications :
- Patient with deep vein thrombosis/pulmonary embolism or antecedent
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BaricitinibBaricitinib, 4 mg/d, oral route for 24 weeks | Drug | baricitinib arm |
| PlaceboPlacebo, 4 mg/d, oral route for 24 weeks | Drug | placebo arm |
Primary outcome
Moderate improvement at 24 weeks without prednisone: prednisone-free moderate improvement.
Time frame: 24 weeks
The rate of patients with a moderate improvement at 24 weeks, defined as a total improvement score superior or equal to 40 following ACR/EULAR definition. The investigator will consider that patients following the planned prednisone tapering scheme (corticosteroids 0 mg/d at W24) will be prednisone-free.
9 secondary outcomes
Dermatomyositis minimal improvement
Time frame: 5, 12 and 24 weeks
Dermatomyositis moderate improvement
Time frame: 5, 12 and 24 weeks
Dermatomyositis major improvement
Time frame: 5, 12 and 24 weeks
Primary endpoint prednisone-free moderate improvement at Weeks 24 in subgroups
Time frame: 24 weeks
Cutaneous disease activity and damage
Time frame: 5, 12 and 24 weeks
Cumulative incidence of relapse
Time frame: up to 24 weeks
Cumulative dose of corticosteroids
Time frame: 24 weeks
Average prednisone dose per day through the last 4 weeks (0 mg per day, of more than 0 mg to not more than 4.0 mg per day, of more than 4.0 mg to not more than 7.5 mg per day, and of more than 7.5 mg per day).
Time frame: 24 weeks
Adverse events
Time frame: up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
YVES ALLENBACH, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Baricitinib in people with Dermatomyositis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YVES ALLENBACH, MD, PhD (00 33 1 42 16 10 68, yves.allenbach@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moderate improvement at 24 weeks without prednisone: prednisone-free moderate improvement. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.