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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
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519930-22-00
Acronym
GA45799
Enrollment
5
Registered
2025-09-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus (SLE) With or Without Active Lupus Nephritis (LN)

Brief summary

Achievement of remission by Week 76

Detailed description

Proportion of participants who achieve DORIS by Week 76, Proportion of participants who achieve CRR at Weeks 52, 76, and 104, Proportion of participants who achieve PRR at Weeks 52, 76, and 104, Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) and Cytokine-Release Syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) severity determined according to the 2019 American Society for Transplantation and Cellular Therapy (ASTCT) CRS and ICANS Consensus grading criteria., Change from baseline in targeted vital signs, Change from baseline in targeted clinical laboratory test results, Longitudinal changes in titers of anti-dsDNA and anti-Smith antibodies, Longitudinal changes in complement C3 and C4, Serum concentrations of mosunetuzumab at specified timepoints, Relevant PK parameters of mosunetuzumab, Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study, B cell levels in the blood (CD19+, absolute counts in blood) at specified timepoints, Change in Functional Assessment of Chronic Illness Therapy (FACIT) – Fatigue from baseline to Week 76, Change in Subject’s Global Assessment of Disease Activity (SGA) from baseline to Week 76

Interventions

DRUGMosunetuzumab

Sponsors

F. Hoffmann-La Roche AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Achievement of remission by Week 76

Secondary

MeasureTime frame
Proportion of participants who achieve DORIS by Week 76, Proportion of participants who achieve CRR at Weeks 52, 76, and 104, Proportion of participants who achieve PRR at Weeks 52, 76, and 104, Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) and Cytokine-Release Syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) severity determined according to the 2019 American Society for Transplantation and Cellular Therapy (ASTCT) CRS and ICANS Consensus grading criteria., Change from baseline in targeted vital signs, Change from baseline in targeted clinical laboratory test results, Longitudinal changes in titers of anti-dsDNA and anti-Smith antibodies, Longitudinal changes in complement C3 and C4, Serum concentrations of mosunetuzumab at specified timepoints, Relevant PK parameters of mosunetuzumab, Prevalence of anti-drug antibodie

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026