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

NCT05125679 | Terminated Phase 4 Results

• 3 other identifiers: CR1090332020-004061-39CNTO1959PSO4015
• Study Type: interventional
• Target: 15
• Locations: 3 countries
• Sites: 5

Brief 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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Coronary Flow Reserve (CFR) at Week 32

  Change from baseline in CFR at Week 32 were reported. CFR was described as ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography. First, initial spectral Doppler signals in distal portion of left anterior descending artery (LAD) was recorded and then adenosine 140 micrograms per kilogram per minute (mcg/kg/min; coronary vasodilator) was administered for 5 minutes. Doppler signals were recorded continuously during the period of adenosine infusion. Baseline (Week 0): last non-missing measurement prior to or on day of 1st dose of guselkumab. CFR is the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest.

  Baseline (Week 0) and Week 32

Secondary Outcomes (16)

• Change From Baseline in CFR at Week 16

  Baseline (Week 0) and Week 16

• Change From Baseline in Absolute Global Longitudinal Strain (GLS) at Week 16

  Baseline (Week 0) and Week 16

• Change From Baseline in Absolute GLS at Week 32

  Baseline (Week 0) and Week 32

• Change From Baseline in Carotid-femoral Pulse Wave Velocity (cfPWV) at Week 16

  Baseline (Week 0) and Week 16

• Change From Baseline in cfPWV at Week 32

  Baseline (Week 0) and Week 32

Study Arms (1)

Guselkumab

EXPERIMENTAL

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

Drug: Guselkumab

Interventions

Guselkumab DRUG

Guselkumab will be administered by subcutaneous injection.

Guselkumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen-Cilag Ltd.: lead

Study Sites (5)

Universitatsklinikum Frankfurt

Frankfurt, 60590, Germany

Location

Universitatsklinikum Leipzig AOR

Leipzig, 4103, Germany

Location

Attikon Hospital

Athens, 12462, Greece

Location

Ospedale San Giovanni di Dio

Cagliari, 09123, Italy

Location

Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

MeSH Terms

Conditions

Psoriasis

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Sponsor terminated the study solely due to lack of enrolment. Due to small number of enrolled participants, it was not possible to evaluate the primary or secondary objectives for this study as planned.

Results Point of Contact

• Title: Senior EMEA Medical Advisor Immunology
• Organization: Janssen-Cilag Limited

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen-Cilag Ltd Clinical Trial

  Janssen-Cilag Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 18, 2021
• Study Start: November 23, 2021
• Primary Completion: July 28, 2023
• Study Completion: July 28, 2023
• Last Updated: March 30, 2025
• Results First Posted: January 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

GR (1); DE (2); IT (2)