eligibility_summary
Eligible: Patients with moderate–severe pemphigus inadequately controlled by external/topical therapy who require systemic treatment and have PDAI >9. Exclude: those with serious underlying diseases, hepatitis B with triple-positive serology, or a history of immunoglobulin-related diseases.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06654817 (observational cohort) in pemphigus vulgaris compares: (1) Ofatumumab + systemic corticosteroids vs (2) standard corticosteroids + azathioprine. Drugs/mechanisms: Ofatumumab—fully human anti-CD20 monoclonal antibody (biologic immunotherapy), given subcutaneously, depletes CD20+ B cells via complement-dependent cytotoxicity and ADCC to reduce pathogenic autoantibodies. Corticosteroids—systemic glucocorticoids, suppress NF-κB/AP-1–mediated cytokines and immune activation (broad anti-inflammatory/immunosuppressive). Azathioprine—thiopurine antimetabolite (prodrug of 6-MP), inhibits de novo purine synthesis, limiting proliferation of T and B lymphocytes. Target cells/pathways: CD20+/CD19+ B cells and humoral autoimmunity producing anti-desmoglein 1/3 antibodies, downstream suppression of inflammatory signaling and autoantibody-driven acantholysis. Primary outcomes: time to disease control and skin healing. Secondary: CD19+ B cells, desmoglein antibodies, PDAI, DLQI, VAS, AEs.