About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Ustekinumab
DrugSubjects will receive ustekinumab for 8 weeks followed by guselkumab or risankizumab for 8 weeks.
Treatment groups
Trial outcomes
Primary outcomes
Identification of a unique differentially expressed gene set in patients with psoriasis that may predict disease response following antagonism to IL-12 and/or IL-23.
Single-cell RNA transcriptomics from whole blood isolate from identify unique differentially expressed gene sets in patients following antagomism to IL-12 and/or IL-23.
Secondary outcomes
Identification of a cell subset that is a modified and predictive of disease response following antagonism to IL-12 and/or IL-23
Single-cell RNA sequencing or flow cytometry to identify a cell subset that is a modified and predictive of disease response following antagonism to IL-12 and/or IL-23.
Sponsors and contacts
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University Hospitals Cleveland Medical Center
Lead sponsor
LEO Foundation
Collaborator
Case Western Reserve University
Collaborator