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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521713-57-00 | EU Trial (CTIS) Number |
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This study is researching an experimental drug called REGN7041 (also referred to as "study drug"). The study is focused on patients who have active inflammation inside of the eye without any signs of infection.
The aim of the study is to see how safe and tolerable the study drug is. This is the first time the study drug is being tested in humans.
The study is looking at several other research questions, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequential Single Ascending Dose Cohorts | Experimental |
| |
| Sequential Multiple Ascending Dose Cohorts | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN7041 | Drug | Administered as per the protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Treatment-Emergent Adverse Events (TEAEs) | Through Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of REGN7041 in serum | Through Week 24 | |
| Incidence of Anti-Drug Antibodies (ADAs) to REGN7041 in serum | Through Week 24 | |
| Magnitude of ADAs to REGN7041 in serum |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Consultants - Sacramento | Sacramento | California | 95825 | United States | ||
| Illinois Retina Associates |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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| ID | Term |
|---|---|
| D015864 | Panuveitis |
| D014605 | Uveitis |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
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| Through Week 24 |
| Oak Park |
| Illinois |
| 60304 |
| United States |
| Tennessee Retina | Nashville | Tennessee | 37203 | United States |
| Retina Consultants of Texas - Houston | Bellaire | Texas | 77401 | United States |
| Retina Consultants of Texas | Katy | Texas | 77494 | United States |