Overall trial status: Authorised, recruiting
Trial title: 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)
Medical conditions: Moderate to Severe Plaque Psoriasis
Status in each country: Belgium:Ended, France:Ongoing, recruitment ended, Portugal:Ongoing, recruitment ended, Germany:Ongoing, recruitment ended, Czechia:Ongoing, recruitment ended, Spain:Ongoing, recruitment ended, Latvia:Ongoing, recruitment ended, Romania:Ended, Estonia:Ongoing, recruitment ended, Bulgaria:Ongoing, recruitment ended, Poland:Ongoing, recruitment ended, Hungary:Ongoing, recruitment ended, Austria:Ended
Trial phase: Therapeutic confirmatory (Phase III)
Therapeutic Areas: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Primary end point: Incidence and severity of treatment-emergent adverse events and serious adverse events
Secondary end point: Long-term efficacy endpoints: * Achievement of ≥75%, ≥90%, and ≥100% reductions in PASI after 24, 48, 72, 96 weeks of overall ESK-001 treatment * Achievement of sPGA-0, sPGA-0/1 and ssPGA after 24, 48, 72, 96 weeks of overall ESK-001 treatment * Mean change from baseline in PASI %BSA, Clinical response endpoints: * Following ESK-001 withdrawal, loss of response in: PASI-75 sPGA-0/1 PASI-90 PASI-100 and median time to loss of response in PASI-75 and sPGA0/1. * After achievement of a response at Week 24 in parent study, maintenance of the response in the following at Weeks 24 and 48 in LTE: PASI-75, PASI-90, and PASI-100 sPGA-0 and sPGA-0/1, Clinical response endpoints (continued): * Lack of response at Week 24 in parent study followed by an achievement of response in the following at Weeks 24 and 48 in LTE: PASI-75, PASI-90, and PASI-100 sPGA-0 and sPGA-0/1, Quality of life endpoints: * Achievement of the following after 24, 48, 72, 96 weeks of overall ESK-001 treatment: DLQI-0/1 Change from baseline in DLQI, PSSD, NRS (Pruritus, Joint Pain, and Joint Disease Activity), SF-36 * After achievement of a response at Week 24 in parent study, maintenance of the response in the following at Weeks 24 and 48 in LTE: DLQI-0/1 4 point improvement in DLQI PSSD-0
Age of participants: 18-64 years, 65+ years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 931
Sponsor: Alumis Inc.
Sponsor type: Pharmaceutical company
Trial product: ESK-001 placebo / Pharmaceutical Form: Film-coated tablet / Route of administration: Oral use / Maximum duration of treatment: 24 weeks, ESK-001
Results posted: No
Overall decision date: 29/04/2025
Countries decision date: AT: 06/05/2025, BE: 29/04/2025, RO: 06/05/2025, LV: 30/04/2025, EE: 06/05/2025, PT: 02/05/2025, FR: 29/04/2025, ES: 30/04/2025, CZ: 30/04/2025, PL: 05/05/2025, HU: 05/05/2025, DE: 30/04/2025, BG: 08/05/2025
Last updated date: 06/07/2026
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