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)
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)
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:
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:
Inclusion Criteria:
Exclusion Criteria:
Nonplaque psoriasis or other inflammatory skin conditions
Immune-mediated conditions commonly associated with psoriasis (eg inflammatory bowel disease). Patients with psoriatic arthritis may participate
Pregnant, lactating, or planning to get pregnant during the study
Use of drugs prior to Study Day 1 that treat or may affect psoriasis:
Lack of clinical response to a TYK2, IL-12, or IL-23 targeted psoriasis treatment
Patients with QTcF >450 msec (males) or >470 msec (females) at Screening
Unstable cardiovascular disease, defined as a recent clinical deterioration or a cardiac hospitalization within the last 3 months
Evidence of recent or recurrent herpes zoster or herpes simplex viral infection
Evidence of active infection or positive test result for hepatitis B, hepatitis C, HIV or TB
History of serious bacterial, fungal, or viral infections that led to hospitalization, or any recent serious infection requiring antibiotic treatment
Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the patient's immune status
Lab abnormalities indicating significant renal, hepatic or bone marrow dysfunction
History of any immune-mediated or inflammatory medical condition for which patient requires current systemic corticosteroids
New Brighton, Minnesota 55112, United States
Debrecen, Hajdú-Bihar 4032, Hungary
Rzeszów, Podkarpackie Voivodeship 50-368, Poland
Santiago de Compostela, A Coruña 15706, Spain