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
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
The objective of the ESK-001-018 long term extension is to evaluate the safety and efficacy of ESK-001 over time. The scientific questions it aims to answer are:
Patients will enter the long-term extension study following completion of one of the parent studies (ESK-001-016 or ESK-001-017) and will receive open-label ESK-001 twice daily for 24 weeks. After 24 weeks, the first 200 patients meeting at least PASI-75 clinical response will be randomly assigned to receive ESK-001 or placebo. At any point during this time, the patients losing the initial clinical response may return to the open-label ESK-001 treatment. Patients who complete Week 48 will return to open-label ESK-001 treatment and they will receive ESK-001 until the end of the study or discontinuation. All the remaining patients not meeting the entry criteria for the randomized withdrawal phase will continue to receive open-label ESK-001 for the remainder of the study.
Patients taking part in the study must be men or women aged at least 18 years old and have completed a previous (parent) study of ESK-001 in moderate to severe plaque psoriasis.
Patients must consent and agree to:
Inclusion Criteria:
Exclusion Criteria:
Pheonix, Arizona 85032, United States
New Brighton, Minnesota 55112, United States
Gahanna, Ohio 43230, United States
Coburg, Ontario K9A 0Z4, Canada
North York, Ontario M3B 0A7, Canada
Tübingen, Baden-Wurttemberg 72076, Germany
Debrecen, Hajdú-Bihar 4032, Hungary
Hokkaido, Sapporo-shi 060-8648, Japan
Seogu, Busan 49241, South Korea
A Coruña, Santiago de Compostela 15706, Spain