Status:
RECRUITING
Development of Predictive Psoriasis Response Endotypes Using Single Cell Transcriptomics
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
LEO Foundation
Case Western Reserve University
Conditions:
Psoriasis
Eligibility:
All Genders
18-89 years
Phase:
PHASE4
Brief 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 t...
Detailed Description
Psoriasis is a chronic systemic skin disease in which pro-inflammatory molecules contribute to the development of scaled inflamed skin and other disease-associated comorbidities such as increased risk...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
November 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT05270733
Start Date
November 10 2022
End Date
December 31 2026
Last Update
March 14 2025
Active Locations (1)
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1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106