Development of Predictive Psoriasis Response Endotypes Using Single Cell Transcriptomics
Development of Predictive Psoriasis Response Endotypes Using Single Cell Transcriptomics in Ustekinumab Responders Versus Non-responders
University Hospitals Cleveland Medical Center
56 participants
Nov 10, 2022
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria8
- 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
Exclusion Criteria7
- 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).
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Interventions
Subjects will receive ustekinumab for 8 weeks followed by guselkumab or risankizumab for 8 weeks.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05270733