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

NCT07598396 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: GA457992024-519930-22-00
• Study Type: interventional
• Target: 30
• Locations: 4 countries
• Sites: 15

Brief Summary

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).

Conditions

Lupus; Systemic Lupus Erythematosus; Lupus Nephritis

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who have achieved remission by Week 76

  Drug-Free Remission is defined as achieving both of the following: Absence of disease activity maintained for 6 months after completion of mosunetuzumab treatment, and; not receiving any SLE-directed therapy (except for antimalarials) during the 6 months. Doses of prednisone (or equivalent) ≤5 mg/day to treat secondary adrenal insufficiency are permitted.

  Up to Week 76

Secondary Outcomes (11)

• Proportion of participants who achieve Definition of Remission in SLE (DORIS) by Week 76

  Up to Week 76

• Proportion of participants who achieve Complete Renal Response (CRR) at Weeks 24, 52, 76, and 104

  Weeks 24, 52, 76, and 104

• Proportion of participants who achieve Partial Renal Response (PRR) at Weeks 24, 52, 76, and 104

  Weeks 24, 52, 76, and 104

• Percentage of participants with adverse events (AEs)

  Up to 2.5 years

• Longitudinal change in titers of anti-double-stranded (ds) DNA

  Up to 2.5 years

Study Arms (1)

Mosunetuzumab

EXPERIMENTAL

Participants will receive mosunetuzumab by subcutaneous (SC) injection.

Drug: Mosunetuzumab

Interventions

Mosunetuzumab DRUG

Participants will receive SC mosunetuzumab.

Mosunetuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (15)

Clnica SER da Bahia

Salvador, Estado de Bahia, 40150-150, Brazil

RECRUITING

L2IP ?Instituto de Pesquisas Clínicas Ltda.

Brasília, Federal District, 70200-730, Brazil

RECRUITING

IPC MT Instituto de Pesquisas Clinicas do Mato Grosso

Cuiab, Mato Grosso, 78020-500, Brazil

RECRUITING

Complexo Hospitalar de Niteroi

Niterói, Rio de Janeiro, 24030-103, Brazil

RECRUITING

LMK Servios Mdicos S/S Ltda

Porto Alegre, Rio Grande do Sul, 90480-000, Brazil

RECRUITING

Hospital das Clinicas de Ribeirao Preto

Ribeiro Preto, São Paulo, 14048-900, Brazil

RECRUITING

Hospital das Clnicas da Faculdade de Medicina da USP

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

Clinica de la Costa S.A.S

Barranquilla, 080020, Colombia

RECRUITING

Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM

Bogotá, 110221, Colombia

RECRUITING

Hospital Pablo Tobon Uribe

Medellín, 050034, Colombia

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Lazio, 00168, Italy

RECRUITING

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

Brescia, Lombardy, 25123, Italy

RECRUITING

Emmed Research

Pretoria, Gauteng, 0002, South Africa

RECRUITING

University of Cape Town Kidney and Hypertension Research Unit

Cape Town, Western Cape, 7925, South Africa

RECRUITING

Winelands Medical Research

Stellenbosch, Western Cape, 7600, South Africa

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Lupus Nephritis

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: GA45799 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. Only); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): May 29, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

ZA (3); BR (7); CO (3); IT (2)