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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)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507193-40-00
Acronym
ESK-001-016
Enrollment
681
Registered
2024-12-10
Start date
2025-01-16
Completion date
2025-11-20
Last updated
2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to Severe Plaque Psoriasis

Brief summary

The proportion of patients who achieve co-primary endpoint (PASI-75 & sPGA-0/1) at Week 16 compared with Placebo

Detailed description

Week 16 Endpoints: *The proportion of patients who achieve 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: *The proportion of patients who achieve 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

Interventions

DRUGESK-001
DRUGOtezla 30 mg film-coated tablets
DRUGOtezla 10mg
DRUG20mg
DRUG30 mg film-coated tablets
DRUGName: ESK-001 placebo Pharmaceutical Form: film-coated tablet Route of administration: Oral use Maximum duration of treatment: 16 weeks
DRUGName: apremilast placebo Pharmaceutical form: Only over-encapsulating capsule shell containing backfill
DRUGno tablet Route of administration: oral use Maximum duration of treatment: 16 weeks

Sponsors

Alumis Inc.
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The proportion of patients who achieve co-primary endpoint (PASI-75 & sPGA-0/1) at Week 16 compared with Placebo—

Secondary

MeasureTime frame
Week 16 Endpoints: *The proportion of patients who achieve 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: *The proportion of patients who achieve 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—

Countries

Belgium, Bulgaria, Czechia, Germany, Poland, Portugal

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026