NCT05270733 Development of Predictive Psoriasis Response Endotypes Using Single Cell Transcriptomics
| NCT ID | NCT05270733 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University Hospitals Cleveland Medical Center |
| Condition | Psoriasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2022-11-10 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 56 participants in total. It began in 2022-11-10 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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).
Contact & Investigator
Kevin Cooper, MD
PRINCIPAL INVESTIGATOR
University Hospitals Cleveland Medical Center
Frequently Asked Questions
Who can join the NCT05270733 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Psoriasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05270733 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05270733 currently recruiting?
Yes, NCT05270733 is actively recruiting participants. Contact the research team at Amy.Johnson@UHhospitals.org for enrollment information.
Where is the NCT05270733 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT05270733 clinical trial?
NCT05270733 is sponsored by University Hospitals Cleveland Medical Center. The principal investigator is Kevin Cooper, MD at University Hospitals Cleveland Medical Center. The trial plans to enroll 56 participants.
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