Phase 1b2a Study to Evaluate Budoprutug Safety and Effects in Adults With Active Systemic Lupus Erythematosus

What this Trial Is About

Researchers are evaluating budoprutug, a humanized monoclonal antibody designed to selectively bind to CD19, in adults aged 18 to 65 years with active, seropositive systemic lupus erythematosus SLE who have not responded adequately to standard treatments. This Phase 1b2a open-label trial aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of budoprutug, focusing on its effect on B cells and immunoglobulin levels. Participants will receive budoprutug as two intravenous infusions administered 14 days apart in ascending dose cohorts. The study includes dose-escalation and dose-expansion phases to evaluate different dose levels. The treatment is given on Day 1 and Day 15, with monitoring continued up to 28 weeks to assess response and safety. Throughout the study, participants will undergo evaluations including clinical laboratory tests and monitoring of vital signs such as blood pressure, heart rate, respiratory rate, and body temperature. Researchers will measure changes in B-cell counts, immunoglobulin levels, and disease activity scores over time. Safety assessments will include tracking adverse events and dose-limiting toxicities. The total study duration extends up to 28 weeks, allowing for thorough observation of budoprutugs effects.

A Phase 1b/2a Study of Budoprutug in Systemic Lupus Erythematosus (SLE)