A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
- Sponsor
- Hoffmann-La Roche
- Study ID
- NCT07598396
- Phase
- PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Mosunetuzumab — DRUGParticipants will receive SC mosunetuzumab.
Study Details
This study will assess how mosunetuzumab works in people who have systemic lupus erythematosus (SLE) who may or may not also have active lupus nephritis (LN).
Key Dates
- Start date
- May 25, 2026
- Status verified
- May 2026
- Primary completion
- Feb 28, 2028
- Completion
- Aug 31, 2028
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: MosunetuzumabParticipants will receive mosunetuzumab by subcutaneous (SC) injection.
Primary Outcome Measure
Proportion of participants who have achieved remission by Week 76 [ Time Frame: Up to Week 76 ]
Central Contacts
- Reference Study ID Number: GA45799 https://forpatients.roche.com/888-662-6728 (U.S. Only)
Related Studies
- Study of Systemic Lupus ErythematosusRecruiting · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Bethesda, Maryland
- Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)Recruiting · Hospital for Special Surgery, New York · Chicago, Illinois
- Duke Lupus RegistryRecruiting · Duke University · Durham, North Carolina
- Systemic Lupus Erythematosus in Gullah HealthRecruiting · Medical University of South Carolina · Charleston, South Carolina