Trials / Completed
CompletedNCT06588738
A Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 862 (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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Envudeucitinib | ESK-001 |
| DRUG | Placebo | Placebo |
| DRUG | Apremilast | Apremilast |
Timeline
- Start date
- 2024-08-20
- Primary completion
- 2025-09-23
- Completion
- 2025-12-18
- First posted
- 2024-09-19
- Last updated
- 2026-04-13
Locations
124 sites across 12 countries: United States, Austria, Canada, Estonia, France, Germany, Hungary, Israel, Latvia, Poland, Puerto Rico, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06588738. Inclusion in this directory is not an endorsement.