A Study of REGN7041 for Active Noninfectious Uveitis in Adult Participants
Key facts
- Who runs it
- Regeneron Pharmaceuticals
- Where
- Bellaire, Katy, Nashville, Oak Park, and Sacramento, United StatesSee the 5 sitesAlso in 1 other country, 2 sites
- Trial code
- Status
- Terminated
- Phase
- Phase 1/2
- People taking part
- 1 person enrolled
- Started
- 17 Dec 2025
- Ended
- 21 Jul 2026
- Type of study
- Interventional, 2 groups
- Treatments tested
- REGN7041
- Record updated
- 17 August 2026
- Why it stopped
- Unfavorable benefit-risk assessment
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- 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; NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply
Where in United States
Also in 1 other country, 2 sites
- Retina Consultants of Texas - HoustonBellaire, United States
- Retina Consultants of TexasKaty, United States
- Tennessee RetinaNashville, United States
- Illinois Retina AssociatesOak Park, United States
- Retinal Consultants - SacramentoSacramento, United States
About the trial
What the trial wants to find out
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.
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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)
The 2 groups in the trial
- Sequential Single Ascending Dose CohortsTreatment being tested
Treatment: REGN7041
- Sequential Multiple Ascending Dose CohortsTreatment being tested
Treatment: REGN7041
Data and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase 1/2a Study of REGN7041 (Anti-CD3 Monoclonal Antibody) in Participants With Active Noninfectious Uveitis Affecting the Posterior Segment
- Record updated
- 17 August 2026