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)

Conditions

Moderate to Severe Plaque Psoriasis

Brief summary

Incidence and severity of treatment-emergent adverse events and serious adverse events

Detailed description

Long-term efficacy endpoints: * Achievement of ≥75%, ≥90%, and ≥100% reductions in PASI after 24, 48, 72, 96 weeks of overall ESK-001 treatment * Achievement of sPGA-0 and sPGA-0/1 after 24, 48, 72, 96 weeks of overall ESK-001 treatment * Mean change from baseline in PASI %BSA ssPGA, Clinical response endpoints: * Following ESK-001 withdrawal, loss of response in: PASI-75 sPGA-0/1 PASI-90 and median time to loss of response in PASI-75 and sPGA0/1. * After achievement of a response at Week 24 in parent study, maintenance of the response in the following at Weeks 24 and 48 in LTE: PASI-75, PASI-90, and PASI-100 sPGA-0 and sPGA-0/1, Clinical response endpoints (continued): * Lack of response at Week 24 in parent study followed by an achievement of response in the following at Weeks 24 and 48 in LTE: PASI-75, PASI-90, and PASI-100 sPGA-0 and sPGA-0/1, Quality of life endpoints: * Achievement of the following after 24, 48, 72, 96 weeks of overall ESK-001 treatment: DLQI-0/1 Change from baseline in DLQI, PSSD, NRS (Pruritus, Joint Pain, and Joint Disease Activity), SF-36 * After achievement of a response at Week 24 in parent study, maintenance of the response in the following at Weeks 24 and 48 in LTE: DLQI-0/1 4 point improvement in DLQI PSSD-0

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Interventions

DRUGESK-001

DRUGESK-001 placebo / Pharmaceutical Form: Film-coated tablet / Route of administration: Oral use / Maximum duration of treatment: 24 weeks

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence and severity of treatment-emergent adverse events and serious adverse events	—

Secondary

Measure	Time frame
Long-term efficacy endpoints: * Achievement of ≥75%, ≥90%, and ≥100% reductions in PASI after 24, 48, 72, 96 weeks of overall ESK-001 treatment * Achievement of sPGA-0 and sPGA-0/1 after 24, 48, 72, 96 weeks of overall ESK-001 treatment * Mean change from baseline in PASI %BSA ssPGA, Clinical response endpoints: * Following ESK-001 withdrawal, loss of response in: PASI-75 sPGA-0/1 PASI-90 and median time to loss of response in PASI-75 and sPGA0/1. * After achievement of a response at Week 24 in parent study, maintenance of the response in the following at Weeks 24 and 48 in LTE: PASI-75, PASI-90, and PASI-100 sPGA-0 and sPGA-0/1, Clinical response endpoints (continued): * Lack of response at Week 24 in parent study followed by an achievement of response in the following at Weeks 24 and 48 in LTE: PASI-75, PASI-90, and PASI-100 sPGA-0 and sPGA-0/1, Quality of life endpoints: * Achievement of the following after 24, 48, 72, 96 weeks of overall ESK-001	—

Measure

Time frame

Long-term efficacy endpoints: * Achievement of ≥75%, ≥90%, and ≥100% reductions in PASI after 24, 48, 72, 96 weeks of overall ESK-001 treatment * Achievement of sPGA-0 and sPGA-0/1 after 24, 48, 72, 96 weeks of overall ESK-001 treatment * Mean change from baseline in PASI %BSA ssPGA, Clinical response endpoints: * Following ESK-001 withdrawal, loss of response in: PASI-75 sPGA-0/1 PASI-90 and median time to loss of response in PASI-75 and sPGA0/1. * After achievement of a response at Week 24 in parent study, maintenance of the response in the following at Weeks 24 and 48 in LTE: PASI-75, PASI-90, and PASI-100 sPGA-0 and sPGA-0/1, Clinical response endpoints (continued): * Lack of response at Week 24 in parent study followed by an achievement of response in the following at Weeks 24 and 48 in LTE: PASI-75, PASI-90, and PASI-100 sPGA-0 and sPGA-0/1, Quality of life endpoints: * Achievement of the following after 24, 48, 72, 96 weeks of overall ESK-001

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Countries

Austria, Belgium, Bulgaria, Czechia, Estonia, France, Germany, Hungary, Latvia, Poland, Portugal, Romania, Spain

Outcome results

None listed