Trial · NCT07598396
A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
NCT07598396, Phase 2, Recruiting, Hoffmann-La Roche
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis. Trials, record NCT07598396. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07598396
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
- NCT number
- NCT07598396
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 30 participants, estimated
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Lupus, Systemic Lupus Erythematosus, Lupus Nephritis
- Interventions
- Mosunetuzumab
- First posted
- 2026-05-20
- Last updated
- 2026-10-19
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of participants who have achieved remission by Week 76 | Up to 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. |
| Secondary | Proportion of participants who achieve Definition of Remission in SLE (DORIS) by Week 76 | Up to 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. |
| Secondary | Proportion of participants who achieve Complete Renal Response (CRR) at Weeks 24, 52, 76, and 104 | 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. |
| Secondary | Proportion of participants who achieve Partial Renal Response (PRR) at Weeks 24, 52, 76, and 104 | 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. |
| Secondary | Percentage of participants with adverse events (AEs) | Up to 2.5 years | |
| Secondary | Longitudinal change in titers of anti-double-stranded (ds) DNA | Up to 2.5 years | |
| Secondary | Longitudinal changes in complement C3 and C4 | Up to 2.5 years | |
| Secondary | Serum concentration of mosunetuzumab | Up to 2.5 years | |
| Secondary | Percentage of participants with anti-drug antibodies (ADAs) | Baseline up to 2.5 years | |
| Secondary | CD19+ absolute counts in blood | Up to 2.5 years |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42309556 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07598396
GET https://conductscience.org/api/trials/v1/NCT07598396/registered