Development of Predictive Psoriasis Response Endotypes Using Single Cell Transcriptomics

ConditionPsoriasis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity Hospitals Cleveland Medical Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Ustekinumab

    Drug

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

Treatment groups

56 Participants
are divided into 1 treatment group
Group A: TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

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.

Time frame
24 weeks

Secondary outcomes

1

Identification of a cell subset that is a modified and predictive of disease response following antagonism to IL-12 and/or IL-23

Single-cell RNA sequencing or flow cytometry to identify a cell subset that is a modified and predictive of disease response following antagonism to IL-12 and/or IL-23.

Time frame
24 weeks

Other outcomes

Sponsors and contacts

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University Hospitals Cleveland Medical Center

Lead sponsor

LEO Foundation

Collaborator

Case Western Reserve University

Collaborator