A Phase 2 interventional study of ESK-001 in Uveitis Posterior Non-Infectious, Uveitis, Intermediate and Noninfectious Panuveitis, sponsored by Alumis Inc. Terminated at 17 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-08-28.
Sponsored by Alumis Inc · Phase 2, Interventional, and Treatment
This is a multi-center, randomized, double-masked, proof-of-concept study in patients with Active Noninfectious Intermediate, Posterior, or Panuveitis.
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.
34 studies on the registry are indexed under Uveitis, Intermediate; 2 are open to participants now.
This study's enrollment of 36 is above the median of 29 across 26 interventional studies indexed under Uveitis, Intermediate.
Browse Uveitis, Intermediate studies →Alumis Inc is the lead sponsor of 13 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 1 (10%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Must have active uveitis at Screening in at least one eye as defined by:
Key Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply.
ESK-001 administered as an oral tablet
Drug: ESK-001
ESK-001 administered as an oral tablet
Drug: ESK-001
Oral tablet
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.
Time frame: 24 Weeks
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
Time to treatment failure on or after Week 24 between 2 ESK-001 treatment groups. Time to treatment failure is defined as time to the visit of the first treatment failure as defined per protocol. Median time to treatment failure in each treatment group will be reported and compared.
Time frame: 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).
Clinical and laboratory assessments including blood tests, ECGs, hematological measures and physical examinations throughout the study. The number and proportion of TEAEs, SAEs, AEs leading to study discontinuation, and AEs of greater than grade 3 severity will recorded per treatment group and across all groups.
Time frame: Through study completion, up to 52 weeks
To characterize the pharmacokinetics (PK) of ESK-001 (Cmax)
Plasma concentrations and PK parameters including steady-state maximum observed concentration (Cmax) for ESK-001 at Day 1, Week 24, and Week 48.
Time frame: Through study completion, up to 48 weeks
To characterize the pharmacokinetics (PK) of ESK-001 (Ctrough)
Plasma concentrations and PK parameters including steady-state trough observed plasma concentration (Ctrough) for ESK-001 at Week 24, and Week 48.
Time frame: Through study completion, up to 48 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2023 to primary completion in Aug 2024, 13 months.
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This study is terminated, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Envudeucitinib
Alumis Inc