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Predicting Psoriasis Treatment Response with Ustekinumab, Guselkumab, or Risankizumab

This study aims to find specific markers or gene patterns that can predict how well people with plaque-type psoriasis will respond to certain medications. This could help doctors choose the best treatment for you from the start, avoiding a trial-and-error approach. You would receive ustekinumab (Stelara) for 8 weeks, followed by either guselkumab (Tremfya) or risankizumab (Skyrizi) for another 8 weeks. Researchers will monitor your skin and collect blood and skin samples, and possibly stool samples or skin swabs. The goal is to identify gene patterns that predict how well you respond to these treatments. This study is currently recruiting 56 participants.

Study design
This interventional study plans to enroll 56 participants. It involves trying two different FDA-approved psoriasis drugs sequentially.
What's involved
You would receive ustekinumab for 8 weeks, then guselkumab or risankizumab for 8 weeks. Researchers will monitor your skin and take blood and skin samples at least three times, and possibly stool samples and/or skin swabs.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 24 weeks after the start of the study.

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NCT05270733

Development of Predictive Psoriasis Response Endotypes Using Single Cell Transcriptomics

Recruiting
PHASE4Ages 18–89InterventionalTreatment
University Hospitals Cleveland Medical Center
~56 participants
Updated 2026-04-02 on ClinicalTrials.gov
What's tested:Ustekinumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Identification of a unique differentially expressed gene set in patients with psoriasis that may predict disease response following antagonism to IL-12 and/or IL-23.
Measured over 24 weeks

Conditions

Psoriasis

Explore related trials

Chronic small plaque psoriasis

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Kevin Cooper, MD · PRINCIPAL_INVESTIGATOR · University Hospitals Cleveland Medical Center

Who to contact

Amy Johnson, MD
[email protected]
216-286-7369
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Identification of a unique differentially expressed gene set in patients with psoriasis that may predict disease response following antagonism to IL-12 and/or IL-23.24 weeks

    Single-cell RNA transcriptomics from whole blood isolate from identify unique differentially expressed gene sets in patients following antagomism to IL-12 and/or IL-23.