ESK-001
Sponsors
Alumis Inc., Alumis Inc
Conditions
Healthy VolunteerHepatic ImpairmentModerate to Severe Plaque PsoriasisNoninfectious PanuveitisPharmacokineticsPlaque PsoriasisRenal ImpairmentSLE
Phase 1
Relative Bioavailability of ESK-001 Tablet Versus Liquid in Healthy Participants
CompletedNCT05330858
Start: 2022-03-17End: 2022-09-20Updated: 2023-05-09
An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver Damage
RecruitingNCT06952634
Start: 2025-04-29End: 2025-12-31Target: 48Updated: 2025-05-01
An Investigational Study of ESK-001 in Participants With Normal Renal Function and Participants With Mild, Moderate, and Severe Impaired Renal Function
CompletedNCT06962774
Start: 2025-04-23End: 2025-08-01Updated: 2025-12-10
An Investigational Study to Evaluate the Cardiac Safety Assessment (TQTc Study) of ESK-001
CompletedNCT07378579
Start: 2024-06-21End: 2024-08-31Updated: 2026-01-30
Phase 2
A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Plaque Psoriasis
CompletedNCT05600036
Start: 2022-09-27End: 2023-07-25Updated: 2025-06-18
POC Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Active Intermediate, Posterior, or Pan NIU
TerminatedNCT05953688
Start: 2023-06-14End: 2024-08-13Updated: 2024-08-28
Phase 2 Placebo-Controlled Study to Assess the Safety and Efficacy of ESK-001 in Active Systemic Lupus Erythematosus
Active, not recruitingNCT05966480
Start: 2023-06-26End: 2027-09-01Updated: 2025-08-01
A Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Efficacy, and Pharmacokinetics of Multiple Dose Levels of ESK-001 in Adult Patients with Systemic Lupus Erythematosus
Active, not recruitingCTIS2022-502105-15-00
Start: 2023-10-20Target: 136Updated: 2025-11-14
Phase 3
A Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001
Active, not recruitingNCT06588738
Start: 2024-08-20End: 2025-12-31Target: 840Updated: 2025-12-09
A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis
Active, not recruitingNCT06586112
Start: 2024-07-25End: 2025-12-31Target: 840Updated: 2025-12-09
A Multicenter, Randomized, Double-Blind, Placebo and Active Comparator Controlled Phase 3 Study to Evaluate the Efficacy and Safety of ESK-001 in Patients with Moderate to Severe Plaque Psoriasis (ONWARD1)
CompletedCTIS2023-507193-40-00
Start: 2025-01-16End: 2025-11-20Target: 681Updated: 2025-12-10
A Multicenter, Randomized, Double-Blind, Placebo and Active Comparator Controlled Phase 3 Study in Patients with Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001 (ONWARD2)
CompletedCTIS2023-508959-39-00
Start: 2025-02-20End: 2025-12-18Target: 608Updated: 2025-10-10
An Extension Study in Patients with Moderate to Severe Plaque Psoriasis to Evaluate the Long-term Safety, Efficacy and Durability of Response to ESK-001 (ONWARD3)
RecruitingCTIS2024-511166-36-00
Start: 2025-06-13Target: 902Updated: 2025-07-22