NCT05953688

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

A Proof-of-Concept, Randomized, Double-Masked Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Active Noninfectious Intermediate, Posterior, or Panuveitis (OPTYK-1)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Alumis Inc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Uveitis Posterior Non-Infectious
• Uveitis, Intermediate
• Noninfectious Panuveitis

Interventions

Type	Name	Description
DRUG	ESK-001	Oral tablet

Timeline

• Start date: 2023-06-14
• Primary completion: 2024-08-13
• Completion: 2024-08-13
• First posted: 2023-07-20
• Last updated: 2024-08-28

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study