Recruiting

Observational Study

Sponsor:

University Hospitals Cleveland Medical Center

Code:

NCT05270733

Conditions

Psoriasis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ustekinumab

Study Details

Brief 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.

Conditions

Psoriasis

Study ID

NCT05270733

Start date

Nov 10, 2022

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

56 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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)

Interventions

Ustekinumab

Subjects will receive ustekinumab for 8 weeks followed by guselkumab or risankizumab for 8 weeks.

Primary outcome measure

  • 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. [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Amy Johnson, MD

216-286-7369Amy.Johnson@UHhospitals.org

Amanda Davies, MBA

216-844-7834Amanda.Davies@UHhospitals.org

Locations

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Kevin Cooper, MD

216-844-7834

Amy Johnson, MD

216-286-7369Amy.Johnson@UHhospitals.org

More Information

Sponsor

University Hospitals Cleveland Medical Center

Last update posted

Apr 2, 2026

Last verified

Mar, 2026

Keywords

  • ustekinumab
  • guselkumab
  • risankizumab
  • psoriasis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center on 2026-04-02.