Tests mosunetuzumab in people with lupus, with or without kidney involvement
Tests mosunetuzumab in adults with lupus, with or without active lupus nephritis.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
Key facts
- Where
- Cape Town, Pretoria, and Somerset West, South AfricaSee the 3 sites
- Phase
- Phase 2
Where in South Africa
- University of Cape Town Kidney and Hypertension Research UnitCape Town, South AfricaTaking people
- Emmed ResearchPretoria, South AfricaTaking people
- Clinical Trials Network HelderbergSomerset West, South AfricaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hoffmann-La Roche
- Trial code
- NCT07598396EU 2024-519930-22-00
- Record updated
- 19 October 2026
- Original description
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).Read full original descriptionShow less
A Phase II Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Mosunetuzumab in Patients With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
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).
Inclusion: Diagnosis of SLE for ≥ 6 months as assessed using the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria at screening.
Exclusion: Treatment with investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment and during the study; Major surgery requiring hospitalization during the 4 weeks prior to screening or during screening, or any planned surgery or procedure requiring hospitalization during the 12 weeks following study drug administration; Alcohol or substance abuse within the 12 months prior to screening; Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within the 12 months prior to screening or during screening; Catastrophic or severe antiphospholipid syndrome within the 12 months prior to screening or during screening. Antiphospholipid syndrome adequately controlled by anticoagulant therapy for at least 2 months prior to screening is acceptable; Active severe or unstable lupus-associated neuropsychiatric disease or where, in the opinion of the investigator, it is likely to require treatment with protocol-disallowed therapies. Examples of neuropsychiatric SLE manifestations include, but are not limited to the following: meningitis, retinitis, cerebral vasculitis, myelopathy, demyelination syndromes, acute confusional state, psychosis, acute stroke or stroke syndrome, cranial neuropathy, status epilepticus or seizures, cerebellar ataxia, and mononeuritis multiplex; History of any non-SLE disease treated with oral, intravenous, or intramuscular corticosteroids for more than 14 days in total during the one year prior to Day 1; History of treatment with any T cell-engaging bispecific antibodies or CAR-T therapy within the past 2 years; Receipt of any live or attenuated vaccine in the 28 days prior to or during screening; Active infection of any kind, excluding fungal infection of the nail beds; Any major episode of infection as defined by the protocol; History of serious recurrent or chronic infection; History of progressive multifocal leukoencephalopathy (PML); Tuberculosis (TB) infection; History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ, within the past 5 years; High risk for clinically significant bleeding or any condition requiring plasmapheresis, IV immunoglobulin, or acute blood product transfusions; Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required.