Actively Recruiting
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
Led by Hoffmann-La Roche · Updated on 2026-05-28
30
Participants Needed
15
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how mosunetuzumab works in adults with systemic lupus erythematosus (SLE), including those who may also have active lupus nephritis (LN). This Phase II open-label study aims to assess the effectiveness, safety, and how the drug moves through the body in this patient group. The study is sponsored by Hoffmann-La Roche and focuses on important measures like remission rates and kidney response over time. Participants will receive mosunetuzumab through subcutaneous (under the skin) injections. The treatment period includes monitoring up to 2.5 years, with assessments of remission by Week 76 and kidney responses at several time points up to Week 104. The study does not involve placebo or masking, allowing all participants to receive the active drug. During the study, participants will undergo various evaluations including blood tests for drug levels, immune markers, and infection monitoring. They will also complete fatigue and disease activity assessments. Safety is closely monitored, including adverse events and immune responses. The overall study participation may last up to 2.5 years, with regular visits to track progress and outcomes.
CONDITIONS
Brief Title
A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of systemic lupus erythematosus (SLE) for at least 6 months based on 2019 EULAR/ACR Classification Criteria at screening
- Age 18 years or older
You will not qualify if you...
- Pregnant or breastfeeding, or planning to become pregnant during the study or contraception period
- Treatment with investigational therapy within 30 days or 5 drug-elimination half-lives before study treatment or during the study
- Major surgery requiring hospitalization within 4 weeks before screening, during screening, or planned within 12 weeks after study drug administration
- Alcohol or substance abuse within 12 months prior to screening
- Active infection of any kind, except fungal nail infections
- Major episodes of infection as defined by the protocol
- History of serious recurrent or chronic infection
- History of progressive multifocal leukoencephalopathy (PML)
- Tuberculosis infection
- History of cancer within past 5 years, including solid tumors and hematological malignancies
- Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within 12 months prior to or during screening
- Catastrophic or severe antiphospholipid syndrome within 12 months prior to or during screening (controlled cases are acceptable)
- High risk for significant bleeding or conditions requiring plasmapheresis, IV immunoglobulin, or acute blood transfusions
- Active severe or unstable lupus-associated neuropsychiatric disease or likely need for disallowed treatments
- History of non-SLE disease treated with corticosteroids for more than 14 days during the year before Day 1
- Treatment with T cell-engaging bispecific antibodies or CAR-T therapy within past 2 years
- Receipt of live or attenuated vaccine within 28 days before or during screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 76 weeks
Participants receive mosunetuzumab by subcutaneous injection as part of their treatment for systemic lupus erythematosus.
Visit schedule according to dosing and assessments up to Week 76
Duration - Up to 2.5 years
Participants are monitored for safety, efficacy, and long-term effects after treatment completion.
Periodic visits for assessments up to 2.5 years
Trial Site Locations
Total: 15 locations
1
Clnica SER da Bahia
Salvador, Estado de Bahia, Brazil, 40150-150
Actively Recruiting
2
L2IP ?Instituto de Pesquisas Clínicas Ltda.
Brasília, Federal District, Brazil, 70200-730
Actively Recruiting
3
IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
Cuiab, Mato Grosso, Brazil, 78020-500
Actively Recruiting
4
Complexo Hospitalar de Niteroi
Niterói, Rio de Janeiro, Brazil, 24030-103
Actively Recruiting
5
LMK Servios Mdicos S/S Ltda
Porto Alegre, Rio Grande do Sul, Brazil, 90480-000
Actively Recruiting
6
Hospital das Clinicas de Ribeirao Preto
Ribeiro Preto, São Paulo, Brazil, 14048-900
Actively Recruiting
7
Hospital das Clnicas da Faculdade de Medicina da USP
São Paulo, São Paulo, Brazil, 05403-000
Actively Recruiting
8
Clinica de la Costa S.A.S
Barranquilla, Colombia, 080020
Actively Recruiting
9
Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM
Bogotá, Colombia, 110221
Actively Recruiting
10
Hospital Pablo Tobon Uribe
Medellín, Colombia, 050034
Actively Recruiting
11
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, Italy, 00168
Actively Recruiting
12
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia, Lombardy, Italy, 25123
Actively Recruiting
13
Emmed Research
Pretoria, Gauteng, South Africa, 0002
Actively Recruiting
14
University of Cape Town Kidney and Hypertension Research Unit
Cape Town, Western Cape, South Africa, 7925
Actively Recruiting
15
Clinical Trials Network Helderberg
Somerset West, Western Cape, South Africa, 7130
Actively Recruiting
Research Team
R
Reference Study ID Number: GA45799 https://forpatients.roche.com/
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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