ESK-001 for Plaque Psoriasis
(ONWARD3 Trial)
Trial Summary
What is the purpose of this trial?
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: * How safe is taking ESK-001 long-term in people with moderate to severe plaque psoriasis? * Does taking ESK-001 long-term reduce the severity of people's plaque psoriasis? 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: * ensure drug daily compliance until end of study or discontinuation. * visit the clinic for checkups and assessments. * provide blood and urine samples.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Research Team
Eligibility Criteria
This trial is for adults over 18 who have moderate to severe plaque psoriasis and completed a prior ESK-001 study. Participants must commit to daily medication, regular clinic visits, and providing blood and urine samples.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Open-label Treatment
Participants receive open-label ESK-001 twice daily for 24 weeks
Randomized Withdrawal
First 200 patients meeting PASI-75 response are randomized to ESK-001 or placebo; others continue open-label treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label Extension
Participants return to open-label ESK-001 treatment until the end of the study or discontinuation
Treatment Details
Interventions
- ESK-001 (Biological)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alumis Inc
Lead Sponsor