ACTIVE_NOT_RECRUITING

A Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001

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 goal of this clinical trial is to learn if ESK-001 works to treat moderate to severe plaque psoriasis. The main questions it aims to answer are: * Does ESK-001 reduce the severity of people's psoriasis? * How safe is ESK-001 in people with moderate to severe plaque psoriasis? The study includes 2 comparators: a placebo control (a 'dummy' tablet that does not contain the medicine ESK-001 but looks just like it) and an active control (apremilast, which is a medicine approved to treat psoriasis). People taking part in this study must be men or women aged at least 18 years and have had plaque psoriasis for at least 6 months, currently moderate to severe. Participants will: * take drug every day for 24 weeks. * visit the clinic for checkups and tests. * fill out questionnaires about their psoriasis, itch severity, and change in quality of life. * be assessed for health issues and side effects, physical examinations, vital signs, heart electrical activity measurements, and psychological health. * provide blood and urine samples.

Official Title

A Multicenter, Randomized, Double-Blind, Placebo and Active Comparator Controlled Phase 3 Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001 (ONWARD2)

Quick Facts

Study Start:2024-08-20
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06588738

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. Diagnosis of plaque psoriasis for ≥6 months
  3. 3. Plaques covering ≥10% of BSA
  4. 4. PASI ≥12
  5. 5. sPGA ≥3
  6. 6. Women of childbearing potential (WOCBP) and males who are sexually active with WOCBP must agree to adhere to highly effective methods of contraception
  1. 1. Nonplaque psoriasis or other inflammatory skin conditions
  2. 2. Immune-mediated conditions commonly associated with psoriasis (eg inflammatory bowel disease). Patients with psoriatic arthritis may participate
  3. 3. Pregnant, lactating, or planning to get pregnant during the study
  4. 4. Use of drugs prior to Study Day 1 that treat or may affect psoriasis:
  5. * Topical within 2 weeks
  6. * Phototherapy or any systemic treatments within 4 weeks
  7. * Any biologic agent targeted to IL-12 or IL-23 within 6 months, oral IL-12 or IL-23 or TNFα inhibitor within 2 months, or IL-17 within 4 months
  8. * Systemic immunosuppressants or immunomodulatory drugs within 4 weeks
  9. * Modulators of B cells within 6 months, or T cells within 3 months
  10. * JAK inhibitors or TYK2 inhibitors within 4 weeks
  11. * PDE4 inhibitor within 2 months
  12. * Any investigational agent, within 30 days or 5 half-lives or is currently enrolled in an investigational study
  13. 5. Lack of clinical response to a TYK2, IL-12, or IL-23 targeted psoriasis treatment
  14. 6. Patients with QTcF \>450 msec (males) or \>470 msec (females) at Screening
  15. 7. Unstable cardiovascular disease, defined as a recent clinical deterioration or a cardiac hospitalization within the last 3 months
  16. 8. Evidence of recent or recurrent herpes zoster or herpes simplex viral infection
  17. 9. Evidence of active infection or positive test result for hepatitis B, hepatitis C, HIV or TB
  18. 10. History of serious bacterial, fungal, or viral infections that led to hospitalization, or any recent serious infection requiring antibiotic treatment
  19. 11. Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the patient's immune status
  20. 12. Lab abnormalities indicating significant renal, hepatic or bone marrow dysfunction
  21. 13. History of any immune-mediated or inflammatory medical condition for which patient requires current systemic corticosteroids

Contacts and Locations

Study Locations (Sites)

Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, 35203
United States
Chandler Clinical Trials
Chandler, Arizona, 85224
United States
Medical Dermatology Specialists
Phoenix, Arizona, 85006
United States
Noble Clinical Research
Tucson, Arizona, 85704
United States
Zenith Research Inc.
Beverly Hills, California, 90211-1705
United States
Raoof MD
Encino, California, 91436
United States
Long Beach Research Institute
Long Beach, California, 90805
United States
Dermatology Research Associates
Los Angeles, California, 90045
United States
Empire Clinical Research - Pomona
Pomona, California, 91767
United States
Integrative Skin Science and Research
Sacramento, California, 95815
United States
UC San Diego
San Diego, California, 92122
United States
Southern California Clinical Research
Santa Ana, California, 92701
United States
Clinical Science Institute Dermatology Institute
Santa Monica, California, 90404
United States
FXM Clinical Research Ft. Lauderdale LLC
Fort Lauderdale, Florida, 33308
United States
Direct Helpers Research Center (DHRC)
Hialeah, Florida, 33012
United States
Green Leaf Clinical Trials
Jacksonville, Florida, 32258
United States
AppleMed Research Group under WCG
Miami, Florida, 33126
United States
FAX Pharma Clinical Research Inc
Miami, Florida, 33146
United States
FXM Clinical Research - Miami LLC
Miami, Florida, 33175
United States
Las Mercedes Medical Research
Miami, Florida, 33196
United States
FXM Clinical Research Miramar LLC
Miramar, Florida, 33027
United States
Renstar Medical Research
Ocala, Florida, 34470
United States
DS Research of Southern Indiana
Clarksville, Indiana, 47129
United States
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168
United States
DS Research of Kentucky
Louisville, Kentucky, 40241
United States
Michigan Center for Research Company
Clarkston, Michigan, 48346
United States
Henry Ford Medical Center - Farmington Road
Detroit, Michigan, 48202
United States
Revival Research Institute
Troy, Michigan, 48084
United States
Grekin Skin Institute
Warren, Michigan, 48088
United States
Associated Skin Care Specialists - Minnesota Clinical Study Center
New Brighton, Minnesota, 55112
United States
Schlessinger MD
Omaha, Nebraska, 68144
United States
Las Vegas Clinical Trials
Las Vegas, Nevada, 89030
United States
NYC Health and Hospitals Elmhurst
Elmhurst, New York, 11373
United States
Pioneer Clinical Research NY
New York, New York, 10016
United States
Cameron Dermatology
New York, New York, 10023
United States
DermResearchCenter of New York
Stony Brook, New York, 11790
United States
Asheville Clinical Trials
Asheville, North Carolina, 28803
United States
WDC Cosmetic and Research
Wilmington, North Carolina, 28405
United States
Optima Research Boardman
Boardman, Ohio, 44512
United States
Synexus Clinical Research US Inc - Cincinnati
Cincinnati, Ohio, 45236
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Clinical Partners LLC
Johnston, Rhode Island, 02919
United States
Arlington Research Center
Arlington, Texas, 76011
United States
Modern Research Associates PLLC
Dallas, Texas, 75231
United States
SMS Clinical Research
Mesquite, Texas, 75149
United States
Progressive Clinical Research - San Antonio
San Antonio, Texas, 78213
United States
Center for Clinical Studies (CCS) - Webster/Clear Lake Location
Webster, Texas, 77598
United States
Jordan Valley Dermatology
South Jordan, Utah, 84095
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 Date2024-08-20
Study Completion Date2025-12

Study Record Updates

Study Start Date2024-08-20
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Plaque Psoriasis