eligibility_summary
Adults 18–70, weight 35–150 kg, BMI 18–35, with investigator-diagnosed active RA, SjD, or SLE, on stable standard of care ≥4 weeks, consented and able to comply. Exclude: prohibited therapies, active/recurrent infection, planned live vaccines, uncontrolled serious disease, pregnant/nursing, WOCBP not on highly effective contraception during and 6 months post, sexually active males must use barrier protection (per local rules). Other criteria apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Ianalumab (VAY736), an afucosylated human IgG1 monoclonal antibody, given subcutaneously at 300 mg monthly via different devices (2 mL auto-injector, two 1 mL pre-filled syringes, or one 2 mL pre-filled syringe). Trial goal: Phase 2, two-period crossover study to show pharmacokinetic comparability and assess safety in adults with rheumatoid arthritis, Sjögren’s disease, or systemic lupus erythematosus. Mechanism of action: binds BAFF receptor (BAFF‑R/TNFRSF13C) on B cells, blocks BAFF/BLyS survival signaling, and enhances ADCC, resulting in B‑cell depletion. Targets: CD19+ BAFF‑R–expressing B cells (naïve/memory) and the BAFF/BLyS pathway, reducing autoantibody production.