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

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

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Active Noninfectious Uveitis Affecting the Posterior Segment
• Intervention / Treatment: Drug: REGN7041

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95825
      • Retinal Consultants - Sacramento
  • Illinois
    • Oak Park, Illinois, United States, 60304
      • Illinois Retina Associates
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Tennessee Retina
  • Texas
    • Bellaire, Texas, United States, 77401
      • Retina Consultants of Texas - Houston
    • Katy, Texas, United States, 77494
      • Retina Consultants of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequential Single Ascending Dose Cohorts	Drug: REGN7041; Administered as per the protocol
Experimental: Sequential Multiple Ascending Dose Cohorts	Drug: REGN7041; Administered as per the protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of Treatment-Emergent Adverse Events (TEAEs)	Through Week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Concentrations of REGN7041 in serum	Through Week 24
Incidence of Anti-Drug Antibodies (ADAs) to REGN7041 in serum	Through Week 24
Magnitude of ADAs to REGN7041 in serum	Through Week 24

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2025
• Primary Completion (Estimated): June 28, 2028
• Study Completion (Estimated): June 28, 2028

Study Registration Dates

• First Submitted: October 16, 2025
• First Submitted That Met QC Criteria: October 16, 2025
• First Posted (Actual): October 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Anterior; Uveitis; Intermediate; Posterior; Panuveitis; NIU-PS; Angiographic Cystoid Macular Edema (CME); Retinal vascular leakage
• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Uveitis; Panuveitis
• Other Study ID Numbers: R7041-NIU-24123; 2025-521713-57-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

IPD Sharing Time Frame

When Regeneron has:

• received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
• made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
• the legal authority to share the data, and
• ensured the ability to protect participant privacy

• IPD Sharing Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No