Development of Predictive Psoriasis Response Endotypes Using Single Cell Transcriptomics

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.

Conditions

Psoriasis

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Study Overview

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Study Details

Study overview

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.

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

Development of Predictive Psoriasis Response Endotypes Using Single Cell Transcriptomics

Condition
Psoriasis
Intervention / Treatment

-

Contacts and Locations

Cleveland

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Diagnosed with plaque-type psoriasis defined by either:
  • * A board-certified dermatologist, OR
  • * Dermatology Nurse Practitioner, OR
  • * Skin punch biopsy
  • * Insurance that includes an anti-p40 biologic (ustekinumab/.Stelara) and at least one anti-p19 biologic (guselkumab/Tremfya or risankizumab/Skyrizi)
  • * Must be naive to ustekinumab, guselkumab, and risankizumab.
  • * Involvement of body surface area (BSA) of at least 10% at screening and baseline visit.
  • * Able to give informed consent under IRB approval procedures
  • * Pregnant, breastfeeding, or planning to get pregnant 8 weeks before, during, and 8 weeks after the study.
  • * Inability to provide informed consent
  • * Inability to secure ustekinumab and either gusekumab or risankizumab for use while on trial
  • * Use of tanning booths for at least 4 weeks prior to baseline visit
  • * 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
  • * Current or recent use of systemic or biologic therapy for at least 8 weeks prior to baseline visit
  • * Patients with psoriatic arthritis or other rheumatologic diseases (e.g., Crohn's disease).

Ages Eligible for Study

18 Years to 89 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University Hospitals Cleveland Medical Center,

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

Study Record Dates

2024-12-31