A Study of REGN7041 for Active Noninfectious Uveitis in Adult Participants (TITAN)

Regeneron Pharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Active Noninfectious Uveitis Affecting the Posterior Segment

Treatments: Drug: REGN7041

Study type: Interventional

Funder types: Industry

Identifiers

NCT07218770

R7041-NIU-24123

2025-521713-57-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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:

• What side effects may happen from taking the study drug
• How much study drug is in the blood and the fluid in the eye at different times
• Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. 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
2. Active disease at baseline, as defined in the protocol
3. 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
4. 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

Key Exclusion Criteria:

1. BCVA of ≤30 ETDRS letters (Snellen equivalent of 20/250 or worse) at the screening visit and/or on day 1
2. Intraocular Pressure (IOP) <5 mm Hg at the screening visit and/or on day 1
3. IOP >25 mm Hg on day 1. Participants are permitted to take IOP-lowering eye drops
4. Confirmed or suspected infectious uveitis, as defined in the protocol

NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Sequential Single Ascending Dose Cohorts

Experimental group

Treatment:

Drug: REGN7041

Sequential Multiple Ascending Dose Cohorts

Experimental group

Treatment:

Drug: REGN7041