Active — Not RecruitingPhase 1/2

A Study of REGN7041 for Active Noninfectious Uveitis in Adult Participants

United States72 participantsStarted 2025-12-17

Plain-language 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)

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Occurrence of Treatment-Emergent Adverse Events (TEAEs)

Timeframe: Through Week 24

Trial details

NCT IDNCT07218770

SponsorRegeneron Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-06-28

View on ClinicalTrials.gov More Active Noninfectious Uveitis Affecting the Posterior Segment trials