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POC Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Active Intermediate, Posterior, or Pan NIU — OPTYK-1  

Uveitis, Intermediate Clinical Trial

Official title:
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)

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05953688
Study type Interventional
Source Alumis Inc
Contact
Status Active, not recruiting
Phase Phase 2
Start date June 14, 2023
Completion date April 30, 2025
View Details
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