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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

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Moderate to Severe Plaque Psoriasis
Date of first enrollment	29/07/2025
Target sample size	60
Countries of recruitment	Australia,Japan,Austria,Japan,Belgium,Japan,Bulgaria,Japan,Canada,Japan,Czechia,Japan,Estonia,Japan,France,Japan,Germany,Japan,Hungary,Japan,Israel,Japan,Latvia,Japan,Poland,Japan,Portugal,Japan,Puerto Rico,Japan,Romania,Japan,Spain,Japan,South Korea,Japan,United Kingdom,Japan,United States,Japan
Study type	Interventional
Intervention(s)	40 mg ESK-001 administered orally twice daily.

Outcome(s)

Primary Outcome	Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1. Males or females, age >=18 years 2. Completed either of the two previous (parent) studies of ESK-001 (ESK-001-016 or ESK-001-017) 3. ESK-001 safety and tolerability were acceptable in the parent study 4. Women of childbearing potential (WOCBP) and males who are sexually active with WOCBP must agree to adhere to highly effective methods of contraception for the entirety of the study
Exclude criteria	1. Pregnant, lactating, or planning to get pregnant during the study period 2. Any acute or chronic illness/condition or evidence of an unstable clinical condition that in the Investigator's judgment will substantially increase the risk to the patient if they continue to receive ESK-001 treatment in this extension study 3. Deemed by the Investigator to be inappropriate for the study or unable to comply with the protocol