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
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Brazil
L2IP ?Instituto de Pesquisas Clínicas Ltda.
RECRUITING
Brasília
IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
RECRUITING
Cuiab
Complexo Hospitalar de Niteroi
RECRUITING
Niterói
LMK Servios Mdicos S/S Ltda
RECRUITING
Porto Alegre
Hospital das Clinicas de Ribeirao Preto
RECRUITING
Ribeiro Preto
Clnica SER da Bahia
RECRUITING
Salvador
Hospital das Clnicas da Faculdade de Medicina da USP
RECRUITING
São Paulo
Colombia
Clinica de la Costa S.A.S
RECRUITING
Barranquilla
Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM
RECRUITING
Bogotá
Hospital Pablo Tobon Uribe
RECRUITING
Medellín
Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
RECRUITING
Brescia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING
Rome
South Africa
University of Cape Town Kidney and Hypertension Research Unit
RECRUITING
Cape Town
Emmed Research
RECRUITING
Pretoria
Clinical Trials Network Helderberg
RECRUITING
Somerset West
Contact Information
Primary
Reference Study ID Number: GA45799 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. Only)
Time Frame
Start Date: 2026-05-25
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 30
Treatments
Experimental: Mosunetuzumab
Participants will receive mosunetuzumab by subcutaneous (SC) injection.
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche