RECRUITING

Development of Predictive Psoriasis Response Endotypes Using Single Cell Transcriptomics

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 investigators propose to improve the possibility of reaching skin resolution by identifying certain markers or gene patterns that may predict patient response to certain psoriasis drugs ahead of time, thus eliminating or reducing the trial-and-error approach often employed. The ability to rule out (or in) specific therapeutics based on predictive efficacy would lead to a more personalized approach for psoriasis treatment. To do this, the investigators will be asking participants to try two different already on the market FDA-approved psoriasis drugs for 8 weeks at a time. The investigators will be monitoring participants skin for improvements as well as taking blood and skin samples at least three times. Investigators may also ask to take stool samples and/or skin swabs.

Official Title

Development of Predictive Psoriasis Response Endotypes Using Single Cell Transcriptomics in Ustekinumab Responders Versus Non-responders

Quick Facts

Study Start:2022-11-10
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05270733

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 to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosed with plaque-type psoriasis defined by either:
  2. * A board-certified dermatologist, OR
  3. * Dermatology Nurse Practitioner, OR
  4. * Skin punch biopsy
  5. * Insurance that includes an anti-p40 biologic (ustekinumab/.Stelara) and at least one anti-p19 biologic (guselkumab/Tremfya or risankizumab/Skyrizi)
  6. * Must be naive to ustekinumab, guselkumab, and risankizumab.
  7. * Involvement of body surface area (BSA) of at least 10% at screening and baseline visit.
  8. * Able to give informed consent under IRB approval procedures
  1. * Pregnant, breastfeeding, or planning to get pregnant 8 weeks before, during, and 8 weeks after the study.
  2. * Inability to provide informed consent
  3. * Inability to secure ustekinumab and either gusekumab or risankizumab for use while on trial
  4. * Use of tanning booths for at least 4 weeks prior to baseline visit
  5. * Current or recent use of topical steroid, tar, phototherapy, Vitamin D, or retinoid therapy to target lesions for at least 2 weeks prior to baseline visit and for duration of trial
  6. * Current or recent use of systemic or biologic therapy for at least 8 weeks prior to baseline visit
  7. * Patients with psoriatic arthritis or other rheumatologic diseases (e.g., Crohn's disease).

Contacts and Locations

Study Contact

Amy Johnson, MD
CONTACT
216-286-7369
Amy.Johnson@UHhospitals.org
Amanda Davies, MBA
CONTACT
216-844-7834
Amanda.Davies@UHhospitals.org

Principal Investigator

Kevin Cooper, MD
PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center

Study Locations (Sites)

University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States

Collaborators and Investigators

Sponsor: University Hospitals Cleveland Medical Center

  • Kevin Cooper, MD, PRINCIPAL_INVESTIGATOR, University Hospitals Cleveland Medical Center

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 Date2022-11-10
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2022-11-10
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • ustekinumab
  • guselkumab
  • risankizumab
  • psoriasis

Additional Relevant MeSH Terms

  • Psoriasis