A Study of REGN7041 for Active Noninfectious Uveitis in Adult Participants

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Regeneron Pharmaceuticals Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Decision date (initial)

2026-03-05

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacodynamic, Pharmacokinetic

To evaluate the ocular and systemic safety and tolerability of single and repeated doses of intravitreally administered REGN7041 in participants with active NIU-PS.

Secondary objectives 2

1. To characterize the single and repeated dose PK of intravitreally administered REGN7041.
2. To assess immunogenicity following intravitreally-administered REGN7041.

Conditions and MedDRA coding

Noninfectious Uveitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

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 4

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 3

1. Concentrations of REGN7041 in serum
2. Incidence of Anti-Drug Antibodies (ADAs) to REGN7041 in serum
3. Magnitude of ADAs to REGN7041 in serum

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Regeneron Pharmaceuticals Inc.

Sponsor organisation

Regeneron Pharmaceuticals Inc.

Address

777 Old Saw Mill River Road

City

Tarrytown

Postcode

10591-6717

Country

United States

Scientific contact point

Organisation

Regeneron Pharmaceuticals Inc.

Contact name

Medical Affairs

Public contact point

Organisation

Regeneron Pharmaceuticals Inc.

Contact name

Medical Affairs

Third parties 3

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications