eligibility_summary
Eligibility: consent, completed NEPTUNUS core study CVAY736A2301/2302 through Week 48 without stopping, investigator expects benefit from continued ianalumab. Exclude: use of prohibited therapies, planned live vaccines, pregnant or breastfeeding, WOCBP not using highly effective contraception or not postmenopausal/sterilized, sexually active males must use condoms (partner contraception recommended/per local rules).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Ianalumab (VAY736), a subcutaneous 300 mg human IgG1 monoclonal antibody immunotherapy targeting BAFF receptor (BAFF-R/TNFRSF13C). Dosing: monthly or every 3 months (with placebo injections between quarterly doses to maintain blinding). Mechanism of action: Blocks BAFF/BLyS binding to BAFF-R and depletes BAFF-R+ B cells via Fc-mediated ADCC, thereby inhibiting BAFF-driven survival/maturation signals and lowering autoreactive B-cell activity and autoantibody production. Targets: BAFF/BLyS–BAFF-R pathway (downstream NF-kB signaling), B-cell compartments expressing BAFF-R (transitional, naive, mature peripheral B cells), with downstream effects on plasmablasts and salivary gland autoimmunity in Sjogren’s syndrome.