Identifying Predictive Markers for Psoriasis Treatment Response
Development of Predictive Psoriasis Response Endotypes Using Single Cell Transcriptomics in Ustekinumab Responders Versus Non-responders
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 |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | University Hospitals Cleveland Medical Center Academic / other |
| Drugs / interventions | ustekinumab, guselkumab, risankizumab, gusekumab |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05270733 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are currently pregnant, breastfeeding, or unable to provide informed consent may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Cleveland, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.