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

Roche

Status and phase

Enrolling

Phase 2

Conditions

Lupus Nephritis

Lupus

Systemic Lupus Erythematosus

Treatments

Drug: Mosunetuzumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT07598396

GA45799

2024-519930-22-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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).

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
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 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
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
High risk for clinically significant bleeding or any condition requiring plasmapheresis, IV immunoglobulin, or acute blood product transfusions
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