Overview

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

Status:
Not yet recruiting
Trial end date:
2023-08-28
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen-Cilag Ltd.
Criteria
Inclusion Criteria:

- The participant has a diagnosis of moderate-to-severe plaque psoriasis (with or
without psoriatic arthritis [PsA]) for at least 6 months prior to the first dose of
guselkumab at Week 0. Moderate-to-severe plaque psoriasis is defined as having a
psoriasis area and severity index (PASI) score greater than or equal to (>=) 12,
investigator global assessment (IGA) score >= 3 and involved body surface area (BSA)
>= 10 percent (%) at Screening Visit S1

- The participant has intermediate cardiovascular risk defined as having a coronary flow
reserve (CFR) score >= 2 to less than or equal to (<=) 3.5 (criterion to be assessed
by cardiologist at Screening Visit S2 and Week 0)

- A female participant of childbearing potential must have a negative highly sensitive
serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at Screening Visit
S1

- Within 2 months before the first administration of guselkumab, the participant has a
negative QuantiFERON-TB Gold test result, or has a newly identified positive
QuantiFERON-TB Gold test result in which active TB has been ruled out and for which
appropriate treatment for latent TB has been initiated before the first administration
of guselkumab

- The participant has a chest radiograph (posterior-anterior view), taken within 3
months before the first administration of study agent and read by a qualified
radiologist, with no evidence of current, active tuberculosis (TB) or old, inactive TB

Exclusion Criteria:

- The participant has a predominantly non-plaque form of psoriasis (example,
erythrodermic, guttate, or pustular)

- The participant has uncontrolled hypertension that needs immediate medical attention
(criterion to be assessed by the dermatologist at Screening Visit S1 and by the
cardiologist at Screening Phase 2)

- The participant has taken any prohibited therapies before the planned first dose of
guselkumab

- A female participant is pregnant, or breastfeeding, or planning to become pregnant
while enrolled in this study or within 5 months after the last dose of guselkumab

- The participant has any clinically significant evidence of cardiac functional or
valvular abnormalities, other than intermediate cardiovascular risk defined by CFR
score >=2 and <=3.5, observed during the CFR assessment (criterion to be assessed by
the dermatologist at Screening Visit S1, and to be confirmed by the cardiologist at
Screening Visit S2)

- The participant has any contraindications to adenosine infusion, or other
contraindications listed in the summary of product characteristics (SmPC) (criterion
to be assessed by the dermatologist at Screening Visit S1 and confirmed by the
cardiologist at Screening Visit S2)