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RecruitingPhase 1Phase 2NCT07218770

A Study of REGN7041 for Active Noninfectious Uveitis in Adult Participants

A Phase 1/2a Study of REGN7041 (Anti-CD3 Monoclonal Antibody) in Participants With Active Noninfectious Uveitis Affecting the Posterior Segment

Sponsor

Regeneron Pharmaceuticals

Enrollment

72 participants

Start Date

Dec 17, 2025

Study Type

INTERVENTIONAL

Conditions

Active Noninfectious Uveitis Affecting the Posterior Segment

Summary

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)

Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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
  • Active disease at baseline, as defined in the protocol
  • 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
  • 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 Criteria4

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

DRUGREGN7041

Administered as per the protocol

Locations(4)

Illinois Retina Associates

Oak Park, Illinois, United States

Tennessee Retina

Nashville, Tennessee, United States

Retina Consultants of Texas - Houston

Bellaire, Texas, United States

Retina Consultants of Texas

Katy, Texas, United States

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NCT07218770