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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 syndro…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Mosunetuzumab is being tested here as a Phase 2 trial, which means we're still in relatively early stages of understanding how well it works and how safe it is in lupus patients — what is known so far about its safety profile, and what risks should I be aware of before considering this?
2The trial measures remission at Week 76, which is about a year and a half away — given how active my lupus is right now, is it reasonable for me to wait that long to see if the treatment is working, or would standard treatments get me to a better place faster?
3This study enrolls people both with and without active lupus nephritis — does my specific situation, including whether my kidneys are currently affected, make me a better or worse candidate for this kind of study compared to other treatment options?
4Mosunetuzumab is a bispecific antibody that targets the immune system in a specific way — how does that approach compare to the immunosuppressive or biologic treatments I might already be on or considering, and would joining this trial mean stopping my current medications?
5Since the trial is still actively recruiting and is in Phase 2, what would happen to my care and treatment if the trial ends early or if I need to withdraw — would I still have access to standard-of-care options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of participants who have achieved remission by Week 76
Timeframe: Up to Week 76
Trial details
NCT IDNCT07598396
SponsorHoffmann-La Roche
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2028-02-28
Contact for this trial
Reference Study ID Number: GA45799 https://forpatients.roche.com/