Development of Predictive Psoriasis Response Endotypes Using Single Cell Transcriptomics

NCT05270733 | Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY20220893
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Keywords

ustekinumab; guselkumab; risankizumab; psoriasis

Outcome Measures

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.

  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

  24 weeks

Study Arms (1)

Treatment

EXPERIMENTAL

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)

Drug: Ustekinumab

Interventions

Ustekinumab DRUG

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

Also known as: Guselkumab, Risankizumab

Treatment

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• LEO Foundation: collaborator
• Case Western Reserve University: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Psoriasis

Interventions

Ustekinumab; guselkumab; risankizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Kevin Cooper, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Johnson, MD

CONTACT

216-286-7369; [email protected]

Amanda Davies, MBA

CONTACT

216-844-7834; [email protected]

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 8, 2022
• Study Start: November 10, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)