A Study of REGN7041 for Active Noninfectious Uveitis in Adult Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-17

Study Completion Date

2028-06-28

Brief Summary

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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)

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Detailed Description

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Conditions

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Active Noninfectious Uveitis Affecting the Posterior Segment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequential Single Ascending Dose Cohorts

Group Type EXPERIMENTAL

REGN7041

Intervention Type DRUG

Administered as per the protocol

Sequential Multiple Ascending Dose Cohorts

Group Type EXPERIMENTAL

REGN7041

Intervention Type DRUG

Administered as per the protocol

Interventions

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REGN7041

Administered as per the protocol

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No