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RecruitingPhase 4

Development of Predictive Psoriasis Response Endotypes Using Single Cell Transcriptomics

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 89 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 8 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks for signs in cells or genes that may help predict which psoriasis drugs will work best. It is for people with plaque psoriasis covering at least 10% of their skin. Participants will try two FDA-approved psoriasis drugs for 8 weeks each and give blood and skin samples at least three times.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have plaque psoriasis diagnosed by a board-certified skin doctor, a skin care nurse practitioner, or a test of a small skin sample.
  • Have insurance that covers ustekinumab (Stelara) and either guselkumab (Tremfya) or risankizumab (Skyrizi).
  • Have never used ustekinumab, guselkumab, or risankizumab.
  • Have psoriasis on at least 10% of your skin at both the screening and starting visits.
  • Be able to understand the study and agree to take part.

Who can't join

  • Are pregnant, breastfeeding, or planning pregnancy within 8 weeks before the study, during it, or within 8 weeks after it.
  • Cannot understand the study and agree to take part.
  • Cannot get ustekinumab and either guselkumab or risankizumab for the study.
  • Use tanning booths in the 4 weeks before the starting visit.
  • Use steroid creams, tar, light treatment, vitamin D, or retinoid treatments on the study skin areas in the 2 weeks before the starting visit or during the study. Retinoids are vitamin A–based medicines.
  • Use medicines that treat the whole body, including biologic drugs, in the 8 weeks before the starting visit.
  • Have psoriatic arthritis (joint swelling linked to psoriasis) or another condition listed as a rheumatologic disease, such as Crohn’s disease.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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).

Study sites (1)

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