eligibility_summary
Adults 18–70 years, 35–120 kg, BMI 18–35, with investigator-confirmed SjD and/or SLE and active disease suitable for B‑cell depletion, on stable allowed SoC ≥4 weeks. Exclude: prohibited therapies, active/recurrent significant infection, live vaccine within 4 weeks, uncontrolled serious disease, pregnant/lactating, WOCBP not using highly effective contraception during treatment and 6 months after. Other criteria may apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06411639 (withdrawn) planned a PK study of ianalumab (VAY736) in Chinese adults with SLE and/or Sjögren’s. Intervention: ianalumab 300 mg subcutaneous monthly. Drug/mechanism: ianalumab is a fully human IgG1 monoclonal antibody (immunotherapy) that binds the BAFF receptor (BAFF‑R/TNFRSF13C) on B cells, blocks BAFF (BLyS) survival signaling, and depletes B cells predominantly via antibody‑dependent cellular cytotoxicity (ADCC). Targets: B lymphocytes (transitional and mature), autoreactive B‑cell/autoantibody pathways, and the BAFF/BLyS–BAFF‑R signaling axis (downstream survival/activation pathways such as NF‑κB). Intended diseases: SLE and Sjögren’s, where B‑cell hyperactivity drives pathology.