REGN7041 for Non-infectious uveitis | Posterior segment uveitis

Inclusion criteria

• {"criterion_text":"- Diagnosis of non-infectious anterior, intermediate, posterior or panuveitis, (For anterior uveitis, there must be evidence of inflammation affecting the posterior segment), as defined in the protocol"}
• {"criterion_text":"- Active disease at baseline, as defined in the protocol"}
• {"criterion_text":"- Part A only: Best Corrected Visual Acuity (BCVA) of ≤65 and >10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (Snellen equivalent of worse than or equal to 20/50 and better than 20/630) at the screening visit and on day 1"}
• {"criterion_text":"- Part B only: BCVA of <75 and >10 ETDRS letters (Snellen equivalent of worse than 20/32 and better than 20/630) at the screening visit and on day 1"}

Exclusion criteria

• {"criterion_text":"- BCVA of ≤30 ETDRS letters (Snellen equivalent of 20/250 or worse) at the screening visit and/or on day 1"}
• {"criterion_text":"- Intraocular Pressure (IOP) <5 mm Hg at the screening visit and/or on day 1"}
• {"criterion_text":"- IOP >25 mm Hg on day 1. Participants are permitted to take IOP-lowering eye drops"}
• {"criterion_text":"- Confirmed or suspected infectious uveitis, as defined in the protocol. NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply"}

Primary endpoints

• {"endpoint_text":"- Occurrence of Treatment-Emergent Adverse Events (TEAEs)","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Concentrations of REGN7041 in serum","definition_or_measurement_approach":""}
• {"endpoint_text":"- Incidence of Anti-Drug Antibodies (ADAs) to REGN7041 in serum","definition_or_measurement_approach":""}
• {"endpoint_text":"- Magnitude of ADAs to REGN7041 in serum","definition_or_measurement_approach":""}

France

Earliest CTIS Part Ii Submission Date

16-02-2026

Latest Decision Or Authorization Date

05-03-2026

Processing Time Days

17

Number Of Sites

2

Number Of Participants

5

Primary sponsor

Full Name

Regeneron Pharmaceuticals Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Parexel International (IRL) Limited

Responsibilities

CRO

Third parties

• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"CRO","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"Slovakia","full_name":"SanaClis s.r.o.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}