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Clinical Trials in Mexico / NCT07598396
Recruiting Phase 2

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

NCT07598396 · tracked via the Priya Life Science Mexico tracker
Phase
Phase 2
Started
2026-05-25
Last updated
2026-09-21

Condition(s) studied

LupusSystemic Lupus ErythematosusLupus Nephritis

Investigational drug(s) / intervention(s)

Mosunetuzumab →

Mosunetuzumab: Participants will receive SC mosunetuzumab.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (22)

FacilityCityRegionStatus
Clnica SER da Bahia Salvador Estado de Bahia Recruiting
L2IP ?Instituto de Pesquisas Clínicas Ltda. Brasília Federal District Recruiting
IPC MT Instituto de Pesquisas Clinicas do Mato Grosso Cuiab Mato Grosso Recruiting
Complexo Hospitalar de Niteroi Niterói Rio de Janeiro Recruiting
LMK Servios Mdicos S/S Ltda Porto Alegre Rio Grande do Sul Recruiting
Hospital das Clinicas de Ribeirao Preto Ribeiro Preto São Paulo Recruiting
Hospital das Clnicas da Faculdade de Medicina da USP São Paulo São Paulo Recruiting
Clinica de la Costa S.A.S Barranquilla Colombia Recruiting
Administradora Country S.A.S. Bogotá Colombia Recruiting
Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM Bogotá Colombia Recruiting
Hospital Pablo Tobon Uribe Medellín Colombia Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Lazio Recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) Brescia Lombardy Recruiting
Istituto Clinico Humanitas Rozzano Lombardy Recruiting
CIMAB S.A. de C.V. Torreón Coahuila Recruiting
Centro Medico del Angel Mexicali Estado de Baja California Recruiting
CREA de Guadalajara, S.C. Guadalajara Jalisco Recruiting
Centro de Investigación y Tratamiento Reumatológico S.C. México Mexico CITY (federal District) Recruiting
Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI) Culiacán Sinaloa Recruiting
Emmed Research Pretoria Gauteng Recruiting
University of Cape Town Kidney and Hypertension Research Unit Cape Town Western Cape Recruiting
Clinical Trials Network Helderberg Somerset West Western Cape Recruiting

More Hoffmann-La Roche trials in Mexico

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07598396 on ClinicalTrials.gov ↗ ← All trials in Mexico