Study Stopped
Terminated based on interim efficacy data that did not meet the Sponsor's criteria.
POC Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Active Intermediate, Posterior, or Pan NIU
OPTYK-1
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)
1 other identifier
interventional
36
1 country
17
Brief Summary
This is a multi-center, randomized, double-masked, proof-of-concept study in patients with Active Noninfectious Intermediate, Posterior, or Panuveitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2023
Shorter than P25 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 14, 2023
CompletedFirst Submitted
Initial submission to the registry
June 29, 2023
CompletedFirst Posted
Study publicly available on registry
July 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 13, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 13, 2024
CompletedAugust 28, 2024
August 1, 2024
1.2 years
June 29, 2023
August 27, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
To compare the efficacy between 2 ESK-001 treatment groups for the treatment of active NIU as measured by the proportion of patients failing treatment by Week 24
The proportion of patients failing treatment for active NIU by Week 24 between 2 ESK-001 treatment groups. Treatment failure is defined as a patient meeting at least 1 of the treatment failure criteria in at least 1 eye at Week 24.
24 Weeks
Secondary Outcomes (4)
To compare the efficacy between 2 ESK-001 treatment groups for the treatment of active NIU as measured by the time to treatment failure on or after Week 24
24 Weeks
To assess the safety and tolerability of ESK-001 in patients with active NIU by comparing the incidence and proportion of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Through study completion, up to 52 weeks
To characterize the pharmacokinetics (PK) of ESK-001 (Cmax)
Through study completion, up to 48 weeks
To characterize the pharmacokinetics (PK) of ESK-001 (Ctrough)
Through study completion, up to 48 weeks
Study Arms (2)
ESK-001 Dose Level 1
EXPERIMENTALESK-001 administered as an oral tablet
ESK-001 Dose Level 2
EXPERIMENTALESK-001 administered as an oral tablet
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- Active inflammatory chorioretinal and/or inflammatory retinal vascular lesion or lesions, or
- ≥ 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 may not qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alumis Inclead
Study Sites (17)
Investigator Site#1065
Beverly Hills, California, 90211, United States
Investigator Site #1073
Los Angeles, California, 90033, United States
Investigator Site #1072
Los Angeles, California, 90095, United States
Investigator Site #1080
Palo Alto, California, 94303, United States
Investigator Site #1079
Sacramento, California, 95825, United States
Investigator Site#1068
Lakewood, Colorado, 80228, United States
Investigator Site #1086
Oak Park, Illinois, 60304, United States
Investigator Site #1085
Hagerstown, Maryland, 21740, United States
Investigator Site #1069
Waltham, Massachusetts, 02451, United States
Investigator Site #1076
Palisades Park, New Jersey, 07650, United States
Investigator Site #1083
Durham, North Carolina, 27705, United States
Investigator Site #1064
Erie, Pennsylvania, 16507, United States
Investigator Site#1066
Nashville, Tennessee, 37203, United States
Investigator Site #1084
Nashville, Tennessee, 37232, United States
Investigator Site#1075
Bellaire, Texas, 77401, United States
Investigator Site #1074
Katy, Texas, 77494, United States
Investigator Site #1078
Plano, Texas, 75075, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2023
First Posted
July 20, 2023
Study Start
June 14, 2023
Primary Completion
August 13, 2024
Study Completion
August 13, 2024
Last Updated
August 28, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share