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

Phase 1

• Conditions: Plaque Psoriasis; MedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2020-004061-39-GR
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-06
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

- Is male or female 18 years of age and above.
- Has a diagnosis of moderate-to-severe plaque psoriasis for at least 6 months prior to the first dose of guselkumab at Week 0. Moderate-to-severe plaque psoriasis is defined as PASI =12, IGA =3 and involved BSA =10% at Screening Visit S1. Participants with a predominantly non-plaque form of psoriasis will not be eligible for inclusion in the study.
-Has intermediate cardiovascular risk defined by CFR =2 to =3.5.
- Is a candidate for systemic treatment for psoriasis.
- Does not have any abnormalities in physical examination, medical history, clinical
laboratory tests, vital signs, and 12-lead ECG performed at screening that are not consistent with the underlying illness in the study population. This determination must be recorded in the participant’s source documents and initialed by the investigator. The 12-lead ECG must be assessed by the dermatologist at Screening Visit S1.
- Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.

For the complete overview of the inclusion criteria, please refer to section 5.1 of the protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- Has low-density lipoprotein >190 mg/dL.
- Has uncontrolled hypertension that needs immediate medication
- Has any clinically significant evidence of cardiac functional or valvular abnormalities, other than intermediate cardiovascular risk defined by CFR =2 and =3.5, including but not limited to: coronary stenosis, history of any MI or transient ischemic attacks, stroke, cerebrovascular disease, peripheral atherosclerosis, congestive heart failure, chronic pulmonary disease, fast atrial fibrillation, supraventricular arrhythmia, valvular abnormalities, ventricular wall movement abnormalities observed during the CFR assessment
- Has any contraindications to adenosine infusion, including but not limited to asthma with ongoing wheezing, hypersensitivity to adenosine, known or suspected bronchoconstrictive or bronchospastic lung disease, greater than first degree heart block without a pacemaker or sick sinus syndrome, systolic blood pressure <90 mmHg and severe sinus bradycardia, or other contraindications listed in the SmPC.
- Unable or unwilling to abstain from caffeine-or nicotine-containing products including but not limited to smoking, vaping, chewing tobacco, nicotine gum and patches for 12
hours prior to the cardiology assessments.
- Has diabetes or has HbA1c >6.5.

For the complete overview of the inclusion criteria, please refer to section 5.2 of the protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified