NCT05270733RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 2 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- First submitted
- 25 Feb 2022
- Start date
- 10 Nov 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Diseases
- Psoriasis
- NCT number
- NCT05270733
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 56
- From 10 Nov 2022 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pregnant, breastfeeding, or planning to get pregnant 8 weeks before, during, and 8 weeks after the study.
- 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
Other illness
- Patients with psoriatic arthritis or other rheumatologic diseases (e.g., Crohn's disease).
Other
- Inability to provide informed consent
- Inability to secure ustekinumab and either gusekumab or risankizumab for use while on trial
Who the study is looking for
- 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
Age in the registry: 18 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals Cleveland Medical Center* Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.