Brentuximab Vedotin for Systemic Sclerosis (BRAVOS)

Diffuse cutaneous systemic sclerosis (dcSSc) remains a severe autoimmune condition with limited therapeutic options and high morbidity. This phase 1/2 multicenter, randomized, double-blind, placebo-controlled study will evaluate the safety and tolerability of brentuximab vedotin, an antibody–drug conjugate that targets CD30, a molecule expressed on activated T and B lymphocytes implicated in fibrotic and immune pathways of dcSSc. The trial uses a dose-escalation design with three ascending dose cohorts to establish safety parameters and inform future efficacy studies.