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NCT Number: NCT07218770

A Study of REGN7041 for Active Noninfectious Uveitis in Adult Participants

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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Active Noninfectious Uveitis Affecting the Posterior Segment Eye Diseases Panuveitis Uveal Diseases Uveitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Retinal Consultants - Sacramento, Sacramento, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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

Key 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

NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply

Treatment and study plan

REGN7041

Drug

Administered as per the protocol

Primary outcomes

  1. Occurrence of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Through Week 24

Secondary outcomes

  1. Concentrations of REGN7041 in serum

    Time frame: Through Week 24

  2. Incidence of Anti-Drug Antibodies (ADAs) to REGN7041 in serum

    Time frame: Through Week 24

  3. Magnitude of ADAs to REGN7041 in serum

    Time frame: Through Week 24

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: TITAN

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 20, 2025
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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