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TerminatedNCT07218770TITANUpdated Aug 17, 2026

A Study of REGN7041 for Active Noninfectious Uveitis in Adult Participants

A Phase 1/2 interventional study of REGN7041 in Active Noninfectious Uveitis Affecting the Posterior Segment, sponsored by Regeneron Pharmaceuticals. Terminated at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by Regeneron Pharmaceuticals · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Unfavorable benefit-risk assessment
Phase
Phase 1/2
Study type
Interventional
Enrollment
1
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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)
02

Conditions studied

  • Active Noninfectious Uveitis Affecting the Posterior Segment

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Keywords

  • NIU-PS
  • Intermediate
  • Posterior
  • Panuveitis
  • Anterior
  • Uveitis
  • Angiographic Cystoid Macular Edema (CME)
  • Retinal vascular leakage
03

In context

Panuveitis

39 studies on the registry are indexed under Panuveitis; 4 are open to participants now.

This study's enrollment of 1 is below the median of 40 across 29 interventional studies indexed under Panuveitis.

Browse Panuveitis studies →

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 411 studies on the registry; 90 are open to participants now.

Of its 125 completed or terminated interventional studies of FDA-regulated products, 79 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    Sequential Single Ascending Dose Cohorts

    Drug: REGN7041

  • Experimental
    Sequential Multiple Ascending Dose Cohorts

    Drug: REGN7041

Interventions

  • DrugREGN7041

    Administered as per the protocol

06

What researchers measure

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

07

Study locations

5 sites
  • Retinal Consultants - Sacramento
    Sacramento, California 95825, United States
  • Illinois Retina Associates
    Oak Park, Illinois 60304, United States
  • Tennessee Retina
    Nashville, Tennessee 37203, United States
  • Retina Consultants of Texas - Houston
    Bellaire, Texas 77401, United States
  • Retina Consultants of Texas
    Katy, Texas 77494, United States
08

References and documents

Individual participant data

Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

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

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

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2025 to primary completion in Jul 2026, 7 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 16, 2025
First posted
Oct 20, 2025
StartActual
Dec 17, 2025
Primary completionActual
Jul 21, 2026
CompletionActual
Jul 21, 2026
Last update
Aug 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07218770
Responsible party
Sponsor
First posted
Oct 20, 2025
Start date
Dec 17, 2025
Primary completion
Jul 21, 2026
Completion
Jul 21, 2026
Last update
Aug 17, 2026

Study contacts

Clinical Trial Management
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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