Identifying Predictive Markers for Psoriasis Treatment Response
Official title: Development of Predictive Psoriasis Response Endotypes Using Single Cell Transcriptomics in Ustekinumab Responders Versus Non-responders
Run by University Hospitals Cleveland Medical Center · NCT05270733 · Data updated 2026-11-12
This study is testing if certain genetic markers can help predict how well people with psoriasis will respond to two different medications over eight weeks.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Enrollment | 56 (estimated) |
| Sponsor | University Hospitals Cleveland Medical Center Academic / other |
| Drugs / interventions | ustekinumab, guselkumab, risankizumab, gusekumab |
| Locations | 1 site (Cleveland, Ohio) |
| Status | Recruiting |
| Started | November 10, 2022 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | April 2, 2026 |
| Trial ID | NCT05270733 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals diagnosed with plaque-type psoriasis who are naive to the studied biologic therapies and have a significant body surface area involvement.
✕Probably not a fit
Patients who are currently pregnant, breastfeeding, or unable to provide informed consent may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to enhance psoriasis treatment by identifying genetic markers that predict how patients will respond to specific biologic therapies. Participants will receive two FDA-approved psoriasis medications over an 8-week period, during which their skin condition will be monitored, and biological samples will be collected for analysis. The goal is to develop a personalized treatment approach that minimizes the trial-and-error method currently used in psoriasis management.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized treatment options for psoriasis patients.
How similar studies have gone: Other studies have shown promise in using genetic markers to predict treatment responses in various conditions, suggesting potential success for this novel approach in psoriasis.
Who can join: the full rules
Show full inclusion / exclusion 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).
Where it's running
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States Recruiting
Study contacts
- Principal investigator: Kevin Cooper, MD — University Hospitals Cleveland Medical Center
- Study coordinator: Amy Johnson, MD
- Email: Amy.Johnson@UHhospitals.org
- Phone: 216-286-7369
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Guselkumab after Ustekinumab in adults with moderate-to-severe psoriasis in routine care
This study looks at how well guselkumab works for people with moderate-to-severe psoriasis after switching from ustekinumab in everyday clinical practice.
-
Investigating how ustekinumab distributes in inflamed tissues for Crohn's disease and psoriasis
This study is testing how well the drug ustekinumab works in people with Crohn's disease and psoriasis who haven't found relief from other treatments by looking at where the drug goes in their inflamed tissues.
-
HB0017 Injection safety and PK in low-weight adults at different injection sites
This early-phase study tests a single subcutaneous HB0017 injection in healthy, low-weight adults and compares how the body processes the drug when injected at different sites.
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MK-8644: first-in-human test in healthy people and people with psoriasis
This early-phase study tests MK-8644 versus placebo in healthy volunteers and people with psoriasis to see if it is safe and tolerable.
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Is XJH05 Ointment Effective for Plaque Psoriasis?
This study tests whether the XJH05 ointment can help people with plaque psoriasis compare to a calcipotriol ointment.
-
TQH3906 capsules vs warmer options in adults with moderate to severe plaque psoriasis
This Phase 3 trial tests whether once-daily TQH3906 capsules can help adults with moderate to severe plaque psoriasis better than a placebo or the active drug deucravacitinib.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.