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Clinical Trials/NCT07218770
NCT07218770TerminatedPhase 1

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

Regeneron Pharmaceuticals5 sites in 1 country1 target enrollmentStarted: December 17, 2025Last updated:
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Interventions

Trial Snapshot

Phase
Phase 1
Status
Terminated
Enrollment
1
Locations
5
Primary Endpoint
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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)

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • •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

Arms & Interventions

Sequential Single Ascending Dose Cohorts

Experimental

Intervention: REGN7041 (Drug)

Sequential Multiple Ascending Dose Cohorts

Experimental

Intervention: REGN7041 (Drug)

Outcomes

Primary Outcomes

Occurrence of Treatment-Emergent Adverse Events (TEAEs)

Time Frame: Through Week 24

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (5)

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