Onward2
Research type
Research Study
Full title
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)
IRAS ID
1011136
Contact name
Clinical Trials
Contact email
Sponsor organisation
Alumis Inc.
Eudract number
2023-508959-39
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to measure the efficacy and safety of ESK-001 (study drug) as compared to active comparator and placebo in participants with Moderate to Severe Plaque Psoriasis. Psoriasis is a disease that causes red, scaly patches on the skin. The most common type of psoriasis is plaque psoriasis, in which these skin patches (plaques) are thick in appearance, causing itching and pain.
Approximately 840 people with moderate to severe plaque psoriasis will take part in the study. Participants will have a 1 in 2 chance of receiving ESK-001 (approximately 420 people), and a 1 in 4 chance of receiving either placebo or apremilast (approximately 210 people each). Neither the participants taking part in the trial, nor the study doctors will know who has taken medicine (ESK-001 or apremilast) or placebo.
Psoriasis-related assessment tools will be used to assess disease severity, signs and symptoms of psoriasis, and extent of body area affected by psoriasis. Participants will be asked to fill out questionnaires about their disease and its associated condition (psoriatic arthritis), itch severity, and change in quality of life. Safety assessments will include checking for health issues and side effects, physical examinations, vital signs, heart electrical activity measurements, psychological health, and blood and urine collection for standard laboratory tests. Blood samples will be collected to evaluate how ESK-001 is absorbed, modified, and removed from the body.
Participants will receive medicine or placebo twice daily for 24 weeks. Participants who complete the 24-week treatment period will be given a chance to participate in the long-term extension study, where everyone receives ESK-001, otherwise they will enter a safety follow-up period of 4 weeks, when participation in the study ends.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
25/NE/0015
Date of REC Opinion
20 Feb 2025
REC opinion
Further Information Favourable Opinion