Overall trial status: Authorised, recruiting
Trial title: 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)
Medical conditions: Moderate to Severe Plaque Psoriasis
Status in each country: Bulgaria:Ongoing, recruitment ended, Belgium:Authorised, recruiting, Portugal:Ongoing, recruitment ended, Poland:Ongoing, recruitment ended, Czechia:Ongoing, recruitment ended, Germany:Ongoing, recruitment ended
Trial phase: Therapeutic confirmatory (Phase III)
Therapeutic Areas: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Primary end point: Achievement of co-primary endpoint (PASI-75 & sPGA-0/1) at Week 16 compared with Placebo
Secondary end point: Week 16 Endpoints: *Achievement of PASI-90, PASI-100, sPGA-0 PASI-75 and sPGA-0/1 compared to apremilast ss-PGA-0/1 PROs: PSSD-0 and DLQI-0/1 *Change from baseline in %BSA Pruritis NRS score, Week 24 Endpoints compared to apremilast: *Achievement of PASI-75, PASI-90, PASI-100 sPGA-0/1, sPGA-0 ss-PGA-0/1 PROs: PSSD-0 and DLQI-0/1 *Change from baseline %BSA Pruritis NRS score
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: 389
Sponsor: Alumis Inc.
Sponsor type: Pharmaceutical company
Trial product: Otezla 10mg, 20mg, 30 mg film-coated tablets, Otezla 30 mg film-coated tablets, ESK-001, Name: ESK-001 placebo Pharmaceutical Form: film-coated tablet Route of administration: Oral use Maximum duration of treatment: 16 weeks, Name: apremilast placebo Pharmaceutical form: Only over-encapsulating capsule shell containing backfill, no tablet Route of administration: oral use Maximum duration of treatment: 16 weeks, Otezla 30 mg film-coated tablets
Results posted: No
Overall decision date: 10/12/2024
Countries decision date: BE: 10/12/2024, DE: 10/12/2024, CZ: 11/12/2024, PT: 11/12/2024, BG: 16/12/2024, PL: 16/12/2024
Last updated date: 11/03/2025
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