Mosunetuzumab for Systemic lupus erythematosus | Lupus nephritis

Inclusion criteria

• {"criterion_text":"- 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\n- Cohort 1 Active Class III and/or Class IV LN per 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) Criteria as confirmed through local laboratory testing of a kidney biopsy sample obtained within 3 months of screening, which must meet all of the following criteria: – ≥3 points on the NIH activity index, excluding any contribution from interstitial activity – < 50% glomerulosclerosis and < 50% tubulointerstitial fibrosis – Concomitant Class V disease is permitted\n- Cohort 1 Participants with biopsy-proven active LN as described above must also meet the following criteria for enrollment: – urinary protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g on a 24-hour urine collection at screening per the central laboratory – C3 complement below the lower limit of normal at screening per the central laboratory – Active LN despite treatment for at least 6 months with standard nonsteroidal LN therapy (e.g. mycophenolate mofetil (MMF), cyclophosphamide, azathioprine, voclosporin, other calcineurin inhibitors, belimumab, rituximab) – Participants previously treated with B-cell-depleting therapy (e.g. rituximab) are eligible to participate as long as the last treatment was given more than 6 months prior to screening\n- Cohort 2 Participants with SLE must have autoantibody positivity, hypocomplementemia, and high disease activity at screening despite treatment with advanced therapy\n- Cohort 2 Active disease despite treatment for at least 6 months with either cyclophosphamide or a biologic (e.g., belimumab, anifrolumab, rituximab or other anti-CD20 agent) – Participants previously treated with B cell-depleting therapy (e.g. rituximab) are eligible to participate as long as the last treatment was given more than 6 months prior to screening\n- Cohort 2 Participants with SLE must have autoantibody positivity, hypocomplementemia, and high disease activity at screening despite treatment with advanced therapy as follows: - Either an anti-double-stranded DNA antibody or anti-Smith antibody above the upper limit of normal at screening per the central laboratory - C3 complement level below the lower limit of normal at screening per the central laboratory - Active disease at screening, defined as total SLEDAI-2K >= 12, as well as extrarenal SLEDAI-2K score >= 8"}

Exclusion criteria

• {"criterion_text":"- Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required. Participants of childbearing potential must have a negative blood pregnancy test result at screening prior to initiation of study treatment\n- 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\n- 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\n- Alcohol or substance abuse within the 12 months prior to screening\n- Active infection of any kind, excluding fungal infection of the nail beds\n- History of progressive multifocal leukoencephalopathy (PML)"}

Primary endpoints

• {"endpoint_text":"- Achievement of drug-free remission by Week 76","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Proportion of participants who achieve DORIS remission by Week 76\n- Proportion of participants who achieve CRR at Weeks 24, 52, 76, and 104\n- Proportion of participants who achieve PRR at Weeks 24, 52, 76, and 104\n- 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.\n- Change from baseline in targeted vital signs\n- Change from baseline in targeted clinical laboratory test results\n- Longitudinal changes in titers of anti-dsDNA and anti-Smith antibodies\n- Longitudinal changes in complement C3 and C4\n- Serum concentrations of mosunetuzumab at specified timepoints\n- Relevant PK parameters of mosunetuzumab\n- Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study\n- B cell levels in the blood (CD19+, absolute counts in blood) at specified timepoints\n- Change in Functional Assessment of Chronic Illness Therapy (FACIT) – Fatigue from baseline to Week 76\n- Change in Subject’s Global Assessment of Disease Activity (SGA) from baseline to Week 76","definition_or_measurement_approach":""}

Italy

Earliest CTIS Part Ii Submission Date

07-08-2025

Latest Decision Or Authorization Date

24-04-2026

Processing Time Days

260

Number Of Sites

4

Number Of Participants

5

Primary sponsor

Full Name

F. Hoffmann-La Roche AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Iqvia Rds Inc.

Responsibilities

Global CRO, Monitoring, Project Management, Regulatory Expertise, Safety Reporting

Third parties

• {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"Global CRO, Monitoring, Project Management, Regulatory Expertise, Safety Reporting","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Central Laboratory","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Investigator Training","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Specialty Lab","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Site Expense Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Nephropathology Associates PLC","duties_or_roles":"Specialty Lab","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"IxRS Provider","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"MicroCoat Biotechnologie GmbH","duties_or_roles":"Specialty Lab","organisation_type":"Pharmaceutical company"}