Psoriasis Clinical Trials

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Development of Predictive Psoriasis Response Endotypes Using Single Cell Transcriptomics in Ustekinumab Responders Versus Non-responders

Who is this study for? Patients with Psoriasis
What treatments are being studied? Ustekinumab
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: f
View:

• 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

Locations
United States
Ohio
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Contact Information
Primary
Amy Johnson, MD
Amy.Johnson@UHhospitals.org
216-286-7369
Backup
Amanda Davies, MBA
Amanda.Davies@UHhospitals.org
216-844-7834
Time Frame
Start Date: 2022-11-10
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 56
Treatments
Experimental: Treatment
Patients will be treated with ustekinumab (90mg at week 0 and week 4 by subcutaneous injection) for 8 weeks followed by treatment with guselkumab (100mg at week 0 and week 4 by subcutaneous injection) or risankizumab (150mg at week 0 and week 4 by subcutaneous injection)
Related Therapeutic Areas
Sponsors
Collaborators: LEO Foundation, Case Western Reserve University
Leads: University Hospitals Cleveland Medical Center

This content was sourced from clinicaltrials.gov