ONWARD3
Research type
Research Study
Full title
An Extension Study in Patients with Moderate to Severe Plaque Psoriasis to Evaluate the Long-term Safety, Efficacy, and Durability of Response to ESK-001 (ONWARD3)
IRAS ID
1011137
Contact name
Clinical Trials
Contact email
Sponsor organisation
Alumis Inc.
Eudract number
2024-511166-36
Research summary
The purpose of this study is to assess the long-term safety and tolerability of ESK-001 (study drug) 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.
Up to 1680 participants with moderate to severe plaque psoriasis will take part in the study.
Participants entering this long-term study following completion of one of the parent Phase 3 studies will receive open-label ESK-001 daily for 24 weeks. Open-label means the patient, study doctors, and other study staff will know what treatment each patient is receiving. From Week 24 to Week 48, the first 200 participants showing response to treatment will receive either placebo or ESK-001 for up to 24 weeks (Group 1). All other participants who were not included in Group 1 will continue to receive open-label ESK-001 for the remainder of the study (Group 2). Any person in Group 1 who loses their response before Week 48 will receive open-label ESK-001 treatment until end of study or discontinuation. Participants in Group 1 who complete Week 48 will receive ESK-001 until end of study or discontinuation.
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.
REC name
West of Scotland REC 1
REC reference
25/WS/0035
Date of REC Opinion
1 May 2025
REC opinion
Further Information Unfavourable Opinion