Plaque Psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 6.5. For the complete overview of the inclusion criteria, please refer to section 5.2 of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Change from baseline in CFR ;Main Objective: To evaluate the effect of guselkumab on CFR measured by transthoracic dopplerechocardiography, in participants with moderate-to-severe psoriasis and intermediate cardiovascular risk;Secondary Objective: - To evaluate the short-term effect of guselkumab on CFR measured by transthoracic dopplere-chocardiography, in participants with moderate-to-severe psoriasis and intermediate cardiovascular risk. -To evaluate the effect of guselkumab on GLS as a surrogate marker of left ventricular function in participants with moderate-to-severe psoriasis and intermediate cardiovascular risk. - To evaluate the effect of guselkumab on arterial stiffness in participants with moderate-to-severe psoriasis and intermediate cardiovascular risk. - To evaluate the effect of guselkumab on CFR among participants in the different CFR categories. - To evaluate the effect of guselkumab on surrogate CV risk markers among nicotine users and non-users in the participant population. - To assess the safety and tolerability of guselkumab in participants with moderate-to severe plaque psoriasis and intermediate cardiovascular risk ;Timepoint(s) of evaluation of this end point: Week 32 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Week 16 and 32;Secondary end point(s): - Change from baseline in CFR at Week 16 - Change from baseline in GLS at Week 32 and change from baseline in GLS at Week 16 - Change from baseline in cfPWV at Week 32 and change from baseline in cfPWV at Week 16. - Change from baseline in CFR at Week 16 and Week 32 among participants with CFR in the ranges of 2 to 2.49, 2.5 to 3, and 3.01 to 3.5 at baseline - Change from baseline in CFR at Week 16 and Week 32 among nicotine users and non-users. - Change from baseline in GLS at Week 16 and Week 32 among nicotine users and non-users. - Change from baseline in cfPWV at Week 16 and Week 32 in nicotine users and non-users - Rate of AEs among participants treated with guselkumab. | — |
Countries
Germany, Greece, Italy, Sweden
Outcome results
None listed