Development of Predictive Psoriasis Response Endotypes Using Single Cell Transcriptomics

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

We 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, we will be asking you to try two different already on the market FDA-approved psoriasis drugs for 8 weeks at a time. We will be monitoring your skin for improvements as well as taking blood and skin samples at least three times. We may also ask to take stool samples and/or skin swabs.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: Case Western Reserve University; LEO Foundation
• Treatments: Ustekinumab

Criteria

Inclusion 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

Exclusion Criteria:

• 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).