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Trial intelligence / Profile preview
Predictive Psoriasis Response Endotypes Using Single Cell Transcriptomics
NCT05270733Phase 4
Key facts
- Status
- Recruiting
- Start
- Nov 2022
- Primary completion
- Dec 2026
- Countries
- 1
- Sponsor
- University Hospitals Cleveland Medical Center
- Modality
- Monoclonal Antibodies
- Drugs
- ustekinumab
- Conditions
- psoriasis
01
Overview
Phase 4, open-label, single-arm trial of ustekinumab in psoriasis, sponsored by University Hospitals Cleveland Medical Center. Primary endpoint: Identification of a unique differentially expressed gene set at 24 weeks. Started Nov 2022; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Treatment
Patients will be treated with ustekinumab for 8 weeks followed by treatment with guselkumab or risankizumab for 8 weeks.
03
Who it enrols
Patients with plaque-type psoriasis (BSA >= 10%) who are naive to ustekinumab, guselkumab, and risankizumab, and have insurance coverage for these biologics.
04
Endpoints
Primary
Identification of a unique differentially expressed gene set
Secondary
Identification of a cell subset that is a modified and predictive of disease response
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