eligibility_summary
Adults 18–70 with dcSSc per ACR/EULAR, ≤60 months from first non‑Raynaud, mRSS 15–45, active disease (e.g. ≤18 mo, mRSS/area progression, ESR ≥30 or hsCRP ≥6, SSc‑ILD w/ ATA+, or mDAI ≥2.5), plus ATA, RNAP3, or ANA (ANA‑only capped). Exclude lcSSc, ACA+ without ATA/RNAP3, prior mRSS drop >10, FVC ≤50% or DLCO ≤40%, PAH WHO ≥III or IV PAH therapy, recent cyclophosphamide/biologics/investigational/antifibrotics, prior B‑cell depleters/chlorambucil/BMT/TLI. Contraception required.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, randomized, double-blind, placebo-controlled study in diffuse cutaneous systemic sclerosis evaluating ianalumab (VAY736), a subcutaneous, fully human monoclonal antibody immunotherapy. Mechanism: ianalumab targets BAFF-R (B‑cell activating factor receptor, TNFRSF13C) on B cells, blocking BAFF/BLyS survival signaling and inducing antibody‑dependent cellular cytotoxicity, leading to B‑cell depletion. Comparator: placebo (then open‑label ianalumab). Target cells/pathways: BAFF‑R–positive B cells (transitional, naive, memory) and the BAFF/BLyS pathway, aiming to reduce autoreactive B‑cell activity and autoantibody production that contribute to inflammation and fibrosis in dcSSc.