Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07391605
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of one of the following:
Dermatomyositis (DM): Probability score ≥55% on the 2017 EULAR/ACR (European Alliance of Associations of Rheumatology/ American College of Rheumatology) criteria for classification of dermatomyositis (corresponding to diagnosis of 'probable or definite' DM). OR Antisynthetase Syndrome (ASyS): Diagnosis based on ACR/EULAR Classification Criteria (1)."
* Participants must have dermatomyositis or antisynthetase syndrome with muscle and/or skin involvement.
* Refractory or intolerance to standard therapy.
* Stable background immunosuppressive therapy for ≥8 weeks.
* Adequate hematologic, renal, hepatic, and pulmonary function (SpO₂ ≥92% on room air).
* Informed consent, compliance with visits, contraception, and vaccinations required.
Exclusion Criteria:
* Isolated interstitial lung disease (ILD) without muscle or skin involvement
* Severe irreversible muscle damage or advanced weakness (e.g., wheelchair-bound).
* Interstitial lung disease (ILD) requiring oxygen, severe pulmonary impairment (FVC ≤45%, DLCO ≤40%), or pulmonary hypertension.
* Other inflammatory myopathies (PM, IMNM, IBM, cancer- or drug-induced myositis, overlap myositis except Sjögren's).
* Other severe neuromuscular, cardiac, pulmonary, or systemic autoimmune diseases requiring immunosuppression.
* Significant uncontrolled chronic illnesses or psychiatric conditions interfering with participation.
* Pregnancy or lactation.
* Recent use of prohibited immunosuppressants/biologics or investigational agents (per washout periods).
* Live vaccination within 4 weeks.
* History of primary immunodeficiency, organ or bone marrow transplant.
* Active or uncontrolled infections: HBV, HCV, HIV, tuberculosis, or recurrent/severe infections.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07391605
Study Brief:
Protocol Section:
NCT07391605