NCT06586112

A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 912 (actual)
• Sponsor: Alumis Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if ESK-001 works to treat moderate to severe plaque psoriasis. The main questions it aims to answer are: * Does ESK-001 reduce the severity of people's psoriasis? * How safe is ESK-001 in people with moderate to severe plaque psoriasis? The study includes 2 comparators: a placebo control (a 'dummy' tablet that does not contain the medicine ESK-001 but looks just like it) and an active control (apremilast, which is a medicine approved to treat psoriasis). People taking part in this study must be men or women aged at least 18 years and have had plaque psoriasis for at least 6 months, currently moderate to severe. Participants will: * take drug every day for 24 weeks. * visit the clinic for checkups and tests. * fill out questionnaires about their psoriasis, itch severity, and change in quality of life. * be assessed for health issues and side effects, physical examinations, vital signs, heart electrical activity measurements, and psychological health. * provide blood and urine samples.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Envudeucitinib	ESK-001
DRUG	Apremilast	Apremilast
DRUG	Placebo	Placebo

Timeline

• Start date: 2024-07-25
• Primary completion: 2025-09-19
• Completion: 2025-11-20
• First posted: 2024-09-19
• Last updated: 2026-04-13

Locations

156 sites across 10 countries: United States, Australia, Bulgaria, Canada, Czechia, Germany, Japan, Poland, Portugal, South Korea

Regulatory

• FDA-regulated drug study