Phase 2 Study of Inebilizumab and Blinatumomab to Treat Adults With Active Systemic Lupus Erythematosus and Refractory Rheumatoid Arthritis

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of two drugs, inebilizumab and blinatumomab, in adults with active and refractory autoimmune diseases such as systemic lupus erythematosus SLE with nephritis and rheumatoid arthritis RA. This phase 2, open-label, multicenter trial aims to better understand how these drugs work in these conditions and their impact on disease activity and kidney health. Participants will receive inebilizumab through intravenous IV infusions in different dosing schedules, or blinatumomab through subcutaneous SC injections at varying doses depending on the subprotocol group. The study includes several parts focusing on different autoimmune conditions and treatment regimens, with some parts no longer recruiting new participants. During the trial, participants will undergo regular assessments including monitoring for adverse events, evaluation of disease activity using specific clinical scores, kidney function tests, and antibody levels. Researchers will track safety and treatment responses over a period of up to 52 weeks, with visits occurring at scheduled intervals to collect data and monitor participant health.

A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases