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TERMINATEDPhase 2NCT05953688

POC Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Active Intermediate, Posterior, or Pan NIU

This is a multi-center, randomized, double-masked, proof-of-concept study in patients with Active Noninfectious Intermediate, Posterior, or Panuveitis.

Lead sponsor: Alumis Inc•17 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Alumis Inc

This study will consist of a 2-week screening period (+7 days), 24-week treatment period, followed by a 24-week extension period, and a 4-week follow up period for a total of up to 55 weeks. Each participant will be randomized to receive one of two doses of ESK-001 daily for 24 weeks. Participants that do not meet the treatment failure criteria at Week 24 will continue into the extension period.

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Able and willing to provide consent
•Male and females, age 18 to 70 years
•Diagnosis of active noninfectious intermediate, posterior or panuveitis
•Must have active uveitis at Screening in at least one eye as defined by:
•1. Active inflammatory chorioretinal and/or inflammatory retinal vascular lesion or lesions, or
•2. ≥ 2+ VH in accordance with the NEI/SUN criteria
•Males and females must use highly effective methods of contraception for the entirety of the study

Exclusion Criteria

•Diagnosis of infectious uveitis
•Has elevated intraocular pressures or severe glaucoma
•Positive for HIV, Hepatitis B or C or active or inadequately latent tuberculosis at screening
•Positive for syphilis at screening
•Patients with QTcF \>450 msec (both males and females) at screening
•Known active malignancy or history of malignancy within the past 5 years
•History of chronic drug or alcohol abuse
•Live vaccines
•No planned ocular or any other surgery during the course of the study

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: August 28, 2024Terms

Trial snapshot

StatusTERMINATED

PhasePHASE2

Enrollment36

Start dateJun 2023

Last updatedAug 28, 2024

Condition

Uveitis Posterior Non-Infectious Uveitis, Intermediate Noninfectious Panuveitis

Locations shown

Investigator Site#1065

Beverly Hills, California

Investigator Site #1073

Los Angeles, California

Investigator Site #1072

Los Angeles, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2024Data synced to Clareo: May 17, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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