Phase II Study Evaluating Mosunetuzumab for Treating Systemic Lupus Erythematosus With or Without Active Lupus Nephritis

What this Trial Is About

Researchers are evaluating how mosunetuzumab works in people with systemic lupus erythematosus SLE, including those who may have active lupus nephritis LN. This Phase II open-label study aims to assess the drugs effects on disease remission and kidney response in this population. Hoffmann-La Roche sponsors the study to understand efficacy, safety, and pharmacokinetics of mosunetuzumab in these patients. Participants will receive mosunetuzumab through subcutaneous SC injections. The study is a single-group design where all participants receive the investigational drug. Treatment and observation will continue up to 2.5 years, with key outcome assessments scheduled up to Week 76 and beyond for kidney response and safety monitoring. During the trial, participants will undergo various assessments including disease activity evaluations, kidney response measurements, blood tests for immune markers, and monitoring for adverse events. Researchers will track remission status, renal outcomes, drug levels, and immune responses. The total study duration extends up to about 2.5 years, including long-term safety follow-up and evaluation of fatigue and disease activity changes.

A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis