eligibility_summary
Adults 18-75 with definite/probable myositis: DM with rash or ASIM with anti-Jo-1 positive (or other antisynthetase Ab). Active disease: MMT-8 <142 plus >=2 core abnormalities (Pt/Phys GDA, extramuscular VAS, enzymes >=1.5x ULN, HAQ-DI >=0.5) and muscle damage <=5/10. On stable SOC or washed out, willing to taper steroids. Exclude: >160 kg, pregnancy, major cardiac disease, recent cancer, immunodeficiency/HIV, TB, serious infections, high damage, IMNM/IBM/drug-induced, interfering MSK/skin disease, wheelchair bound, severe ILD, overlap CTD.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2 randomized, double-blind, placebo-controlled trial in adults with dermatomyositis (DM) or anti‑synthetase inflammatory myositis (ASIM). Intervention: Daxdilimab (HZN‑7734), a humanized IgG1 monoclonal antibody given subcutaneously, comparator: placebo. Mechanism of action: Daxdilimab binds ILT7 on plasmacytoid dendritic cells (pDCs) and drives Fc‑mediated depletion/inhibition of pDCs, reducing type I interferon (IFN‑α/β) production and downstream interferon‑stimulated inflammatory pathways. Targets: pDCs, ILT7 receptor, type I IFN axis (including TLR7/9‑pDC signaling). Objectives: reduce overall disease activity and skin symptoms, enable steroid‑sparing, assess PK, immunogenicity, and safety.