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

• Status: Active, not recruiting
• Trial end date: 2025-04-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alumis Inc

Criteria

Key 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

Key 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

Other protocol-defined inclusion/exclusion criteria apply.