Moderate to Severe Plaque Psoriasis
Conditions
Interventions
Sponsors
Kojima Yuri
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) | — |
Countries
Australia, Bulgaria, Canada, Czechia, Estonia, France, Germany, Hungary, Japan, Latvia, Poland, Portugal, Puerto Rico, South Korea, Spain, United States
Contacts
Public ContactYuri Kojima
Fortrea Japan K.K.
Outcome results
None listed