RECRUITING

Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-08
Study Completion:2028-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06846541

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Males or females, age ≥18 years
  2. 2. Completed either of the two previous (parent) studies of ESK-001 (ESK-001-016 or ESK-001-017)
  3. 3. ESK-001 safety and tolerability were acceptable in the parent study
  4. 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
  1. 1. Pregnant, lactating, or planning to get pregnant during the study period
  2. 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. 3. Deemed by the Investigator to be inappropriate for the study or unable to comply with the protocol

Contacts and Locations

Study Contact

Alumis Information
CONTACT
(650) 231-6625
clinicaltrials@alumis.com

Study Locations (Sites)

Alliance Dermatology
Pheonix, Arizona, 85032
United States
Dermatology Research Associates
Los Angeles, California, 90045
United States
Therapeutics Clinical Research
San Diego, California, 92123
United States
Direct Helpers Research Center
Hialeah, Florida, 33012
United States
Arlington Dermatology
Rolling Meadows, Illinois, 60008
United States
Dawes Fretzin Clinical Research Group
Columbus, Indiana, 47201
United States
The South Bend Clinic
South Bend, Indiana, 46617
United States
Center for Clinical Studies (CCS) - Webster/Clear Lake Location
Webster, Texas, 77598
United States

Collaborators and Investigators

Sponsor: Alumis Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-08
Study Completion Date2028-11

Study Record Updates

Study Start Date2025-01-08
Study Completion Date2028-11

Terms related to this study

Keywords Provided by Researchers

  • Psoriasis
  • PASI
  • Safety
  • ESK-001

Additional Relevant MeSH Terms

  • Plaque Psoriasis
  • Psoriasis (PsO)
  • Psoriasis
  • Moderate Psoriasis
  • Severe Psoriasis