Effect of Guselkumab on Cardiovascular Risk Surrogate Markers in Participants With Moderate to Severe Plaque Psoriasis

Sponsor
Janssen-Cilag Ltd.
Study ID
NCT05125679
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Guselkumab — DRUG
    Guselkumab will be administered by subcutaneous injection.

Study Details

The purpose of this study is to evaluate the effect of guselkumab on coronary flow reserve (CFR), measured by transthoracic doppler-echocardiography, in participants with moderate-to-severe psoriasis and intermediate cardiovascular risk.

Key Dates

Start date
Nov 23, 2021
Status verified
Mar 2025
Primary completion
Jul 28, 2023
Completion
Jul 28, 2023

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Guselkumab
    Participants will receive guselkumab 100 milligrams (mg) by subcutaneous injection at Weeks 0, 4, 12, 20 and 28.

Primary Outcome Measure

Change From Baseline in Coronary Flow Reserve (CFR) at Week 32 [ Time Frame: Baseline (Week 0) and Week 32 ]

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