A Phase 2 interventional study of Mosunetuzumab in Lupus, Systemic Lupus Erythematosus and Lupus Nephritis, sponsored by Hoffmann-La Roche. Recruiting at 24 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
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).
340 studies on the registry are indexed under Lupus Nephritis; 135 are open to participants now.
This study's planned enrollment of 30 is below the median of 48 across 242 interventional studies indexed under Lupus Nephritis.
Browse Lupus Nephritis studies →Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
Compared within Lupus Nephritis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lupus Erythematosus, Systemic. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive mosunetuzumab by subcutaneous (SC) injection.
Drug: Mosunetuzumab
Participants will receive SC mosunetuzumab.
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.
Time frame: Up to Week 76
Proportion of participants who achieve Definition of Remission in SLE (DORIS) by Week 76
DORIS remission is defined as achievement of all of the following for at least 6 months: Clinical systemic lupus erythematosus disease activity index (cSLEDAI) = 0 after completion of mosunetuzumab treatment; stable dosing of SLE therapies for at least 6 months; Physician Global Assessment (PGA) of \< 0.5, and; prednisone (or equivalent) dose ≤5 mg/day.
Time frame: Up to Week 76
Proportion of participants who achieve Complete Renal Response (CRR) at Weeks 24, 52, 76, and 104
CRR is defined as all of the following: Urinary protein-to-creatinine ratio (UPCR) \< 0.5 g/g, and; estimated glomerular filtration rate (eGFR) ≥ 85% of baseline, as calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation or ≥ 60 ml/min per 1.73 m\^2 of body-surface area.
Time frame: Weeks 24, 52, 76, and 104
Proportion of participants who achieve Partial Renal Response (PRR) at Weeks 24, 52, 76, and 104
PRR is defined as all of the following: ≥ 50% reduction in UPCR from baseline; UPCR \< 1 g/g (or \< 3 g/g if the baseline UPCR was ≥ 3 g/g), and; eGFR ≥85% of baseline, as calculated using the CKD-EPI equation.
Time frame: Weeks 24, 52, 76, and 104
Percentage of participants with adverse events (AEs)
Time frame: Up to 2.5 years
Longitudinal change in titers of anti-double-stranded (ds) DNA
Time frame: Up to 2.5 years
Longitudinal changes in complement C3 and C4
Time frame: Up to 2.5 years
Serum concentration of mosunetuzumab
Time frame: Up to 2.5 years
Percentage of participants with anti-drug antibodies (ADAs)
Time frame: Baseline up to 2.5 years
CD19+ absolute counts in blood
Time frame: Up to 2.5 years
Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue
Time frame: Baseline to Week 76
Change in Subject's Global Assessment of Disease Activity (SGA)
Time frame: Baseline to Week 76
Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Mosunetuzumab