Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

Summary

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

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)

Details

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.

Keywords

Uveitis Posterior Non-Infectious, Uveitis, Intermediate, Noninfectious Panuveitis, Uveitis, Panuveitis, Intermediate Uveitis, Pars Planitis, ESK-001

Eligibility

You can join if…

Open to people ages 18-70

  • 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

You CAN'T join if...

  • 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.

Locations

  • Investigator Site #1072
    Los Angeles California 90095 United States
  • Investigator Site#1065
    Beverly Hills California 90211 United States
  • Investigator Site #1073
    Los Angeles California 90033 United States
  • Investigator Site #1079
    Sacramento California 95825 United States
  • Investigator Site #1080
    Palo Alto California 94303 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alumis Inc
ID
NCT05953688
Phase
Phase 2 Uveitis Research Study
Study Type
Interventional
Participants
About 36 people participating
Last Updated