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eligibility_summary
Inclusion: Adults ≥18 with progressive ILD in 24 mo (FVC ≥10%, or FVC 5–10% plus symptoms/HRCT or DLCO ≥15%, or symptoms+HRCT) and inflammatory evidence (compatible histology or BAL lymphocytosis >20%), French social security, consent, compliant. Exclusion: other major lung/heart disease (e.g., IPF/CTD-ILD/sarcoid/PH), 6MWD ≤100 m, UIP/NSIP, recent therapy change, prior rituximab/biologics, transplant list, pregnancy, infection risks, hypersensitivity, other trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05596786 (EvER-ILD2) is a Phase 3, multicenter, double-blind, placebo-controlled trial in progressive ILD with an inflammatory component, testing IV rituximab (two 1000 mg infusions, days 1 and 15) vs saline. Drug/intervention: Rituximab—chimeric anti-CD20 monoclonal antibody (biologic immunotherapy). Mechanism: depletes CD20+ B cells via complement- and Fc-mediated cytotoxicity and apoptosis, reducing BCR signaling, autoantibody production, and ectopic germinal-center activity. Targets: CD20+ B lymphocytes, pathways linked to autoimmunity/immune-complex and cytokine-driven lung inflammation.