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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519930-22-00 | EU Trial (CTIS) Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mosunetuzumab | Experimental | Participants will receive mosunetuzumab by subcutaneous (SC) injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mosunetuzumab | Drug | Participants will receive SC mosunetuzumab. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Week 76 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: GA45799 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 (U.S. Only) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clnica SER da Bahia | Recruiting | Salvador | Estado de Bahia | 40150-150 | Brazil | |
| L2IP ?Instituto de Pesquisas Clínicas Ltda. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42309556 | Derived | Martins E, Chindalore VL, Sheng XR, Schroeder AV, Chen V, Mody H, Arjomandi A, Mao HA, Hassan I, Dankiewicz-Fares I, Agachi S, Omachi TA, Garg JP, Pendergraft WF 3rd. Phase Ib, multicentre, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneously administered mosunetuzumab in participants with systemic lupus erythematosus. Lupus Sci Med. 2026 Jun 17;13(1):e002019. doi: 10.1136/lupus-2026-002019. |
| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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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
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| 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. | 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. | Weeks 24, 52, 76, and 104 |
| Percentage of participants with adverse events (AEs) | Up to 2.5 years |
| Longitudinal change in titers of anti-double-stranded (ds) DNA | Up to 2.5 years |
| Longitudinal changes in complement C3 and C4 | Up to 2.5 years |
| Serum concentration of mosunetuzumab | Up to 2.5 years |
| Percentage of participants with anti-drug antibodies (ADAs) | Baseline up to 2.5 years |
| CD19+ absolute counts in blood | Up to 2.5 years |
| Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue | Baseline to Week 76 |
| Change in Subject's Global Assessment of Disease Activity (SGA) | Baseline to Week 76 |
| Recruiting |
| Brasília |
| Federal District |
| 70200-730 |
| Brazil |
| IPC MT Instituto de Pesquisas Clinicas do Mato Grosso | Recruiting | Cuiab | Mato Grosso | 78020-500 | Brazil |
| Complexo Hospitalar de Niteroi | Recruiting | Niterói | Rio de Janeiro | 24030-103 | Brazil |
| LMK Servios Mdicos S/S Ltda | Recruiting | Porto Alegre | Rio Grande do Sul | 90480-000 | Brazil |
| Hospital das Clinicas de Ribeirao Preto | Recruiting | Ribeiro Preto | São Paulo | 14048-900 | Brazil |
| Hospital das Clnicas da Faculdade de Medicina da USP | Recruiting | São Paulo | São Paulo | 05403-000 | Brazil |
| Clinica de la Costa S.A.S | Recruiting | Barranquilla | 080020 | Colombia |
| Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM | Recruiting | Bogotá | 110221 | Colombia |
| Hospital Pablo Tobon Uribe | Recruiting | Medellín | 050034 | Colombia |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Rome | Lazio | 00168 | Italy |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) | Recruiting | Brescia | Lombardy | 25123 | Italy |
| Emmed Research | Recruiting | Pretoria | Gauteng | 0002 | South Africa |
| University of Cape Town Kidney and Hypertension Research Unit | Recruiting | Cape Town | Western Cape | 7925 | South Africa |
| Clinical Trials Network Helderberg | Recruiting | Somerset West | Western Cape | 7130 | South Africa |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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