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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522904-26-00 | EU Trial (CTIS) Number |
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The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of cevostamab in participants with systemic lupus erythematosus (SLE) with or without active lupus nephritis (LN).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation and Expansion | Experimental | The study consists of a dose-escalation stage followed by an expansion stage. Participants in both stages will receive Cevostamab in a step-up dosing regimen, followed by a target dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cevostamab | Drug | Participants will receive cevostamab IV as per the schedule given in the protocol. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events (AEs) | Up to approximately 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of Cevostamab | Up to approximately 52 weeks | |
| Area Under the Concentration-Time Curve (AUC) of Cevostamab | Up to approximately 52 weeks | |
| Maximum Observed Serum Concentration (Cmax) of Cevostamab |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: GA46280 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
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| 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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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
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| Tocilizumab | Drug | Tocilizumab may be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event. |
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| Up to approximately 52 weeks |
| Minimum Observed Serum Concentration (Cmin) of Cevostamab | Up to approximately 52 weeks |
| Clearance (CL) of Cevostamab | Up to approximately 52 weeks |
| Volume of Distribution at Steady State (Vdss) of Cevostamab | Up to approximately 52 weeks |
| Change from Baseline in the Presence Anti-Drug Antibodies (ADAs) | Up to approximately 52 weeks |