Frontlight ResearchEarly access
TerminatedPhase 2
POC Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Active Intermediate, Posterior, or Pan NIU
Key facts
- Who runs it
- Alumis Inc
- Where
- Bellaire, Beverly Hills, Durham, Erie, Hagerstown, Katy, Lakewood, Los Angeles, Nashville, Oak Park, Palisades Park, Palo Alto, Plano, Sacramento, and Waltham, United StatesSee the 17 sites
- Trial code
- Status
- Terminated
- Phase
- Phase 2
- People taking part
- 36 people enrolled
- Started
- 14 Jun 2023
- Ended
- 13 Aug 2024
- Type of study
- Interventional, 2 groups
- Treatments tested
- ESK-001
- Record updated
- 28 August 2024
- Why it stopped
- Terminated based on interim efficacy data that did not meet the Sponsor's criteria.
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- Live vaccines
- No planned ocular or any other surgery during the course of the study; Other protocol-defined inclusion/exclusion criteria apply
- Positive for HIV, Hepatitis B or C or active or inadequately latent tuberculosis at screening
- Known active malignancy or history of malignancy within the past 5 years
- History of chronic drug or alcohol abuse
- Diagnosis of infectious uveitis
- Has elevated intraocular pressures or severe glaucoma
- Positive for syphilis at screening
- Patients with QTcF >450 msec (both males and females) at screening
Where in United States
- Bellaire, TexasHospital not named in the registry
- Beverly Hills, CaliforniaHospital not named in the registry
- Durham, North CarolinaHospital not named in the registry
- Erie, PennsylvaniaHospital not named in the registry
- Hagerstown, MarylandHospital not named in the registry
- Katy, TexasHospital not named in the registry
- Lakewood, ColoradoHospital not named in the registry
- Los Angeles, CaliforniaHospital not named in the registry
- Los Angeles, CaliforniaHospital not named in the registry
- Nashville, TennesseeHospital not named in the registry
- Nashville, TennesseeHospital not named in the registry
- Oak Park, IllinoisHospital not named in the registry
- Palisades Park, New JerseyHospital not named in the registry
- Palo Alto, CaliforniaHospital not named in the registry
- Plano, TexasHospital not named in the registry
- Sacramento, CaliforniaHospital not named in the registry
- Waltham, MassachusettsHospital not named in the registry
About the trial
What the trial wants to find out
This is a multi-center, randomized, double-masked, proof-of-concept study in patients with Active Noninfectious Intermediate, Posterior, or Panuveitis.
The 2 groups in the trial
- ESK-001 Dose Level 1Treatment being tested
ESK-001 administered as an oral tablet
Treatment: ESK-001
- ESK-001 Dose Level 2Treatment being tested
ESK-001 administered as an oral tablet
Treatment: ESK-001
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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)
- Record updated
- 28 August 2024