A Real-world Study of Patients With Hidradenitis Suppurativa and High Cardiovascular Risk or Established Coronary Plaque Treated With Secukinumab

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorNovartis Pharmaceuticals

About this trial

The aim of this study is to assess the real-world effects of secukinumab in adult participants with moderate-to-severe Hidradenitis Suppurativa (HS), particularly focusing on its potential impact on coronary atherosclerotic plaque progression or stability. Participants will be enrolled at a single dermatology and cardiology center in Italy and will receive secukinumab as part of their routine clinical care

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult participants aged ≥18 and ≤75 years.

Diagnosis of moderate-to-severe HS (International Hidradenitis Suppurativa Severity Score System [IHS4] ≥4).

Taking or planning to take secukinumab according to standard of care.

Evidence of coronary atherosclerotic plaque previously identified by imaging and receipt of stable, guideline-directed medical therapy.

Disqualifiers

Known history of previous Myocardial Infarction (MI), Acute Coronary Syndromes (ACS) or Transient Ischemic Attack (TIA) requiring urgent intervention/hospitalization in the last 6 months prior to enrollment.

Use of investigational cardiovascular or anti-inflammatory drugs.

Use of any other investigational drugs.

Chronic Kidney Disease (estimated Glomerular Filtration Rate [eGFR] <30 mL/min).

Trial population

Adult participants diagnosed with moderate-to-severe HS who receive secukinumab as part of their routine clinical care at a single dermatology and cardiology center in Italy.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

34 Participants
are grouped into 1 trial group
Group A: Secukinumab Cohort

Trial outcomes

Primary outcomes

1

Proportion of Participants With Lack of Clinically Significant Progression of Coronary Atherosclerotic Plaque Between Baseline and 12 Months, as Measured by PCCT

Lack of clinically significant progression is defined as follows: • For participants with established coronary atherosclerotic plaque at baseline: no ≥10% increase in total plaque volume (mm\^3) • For participants with no detectable atherosclerotic plaque at baseline and a high risk of developing atherosclerotic cardiovascular disease (ASCVD): no new detectable plaque formation.

Time frame
Baseline to 12 months

Secondary outcomes

1

Number and Percentage of Participants With No Changes, Positive Changes, and Negative Changes in Coronary Artery Calcium (CAC) Score Between Baseline and 12 Months

CAC score will be assessed by the Agatston method via PCCT using the classification according to the CAC-Data and Reporting System (DRS) categories. Each category represents a progressively higher risk of cardiovascular disease. CAC-DRS categories: * A0: 0 (no calcium) * A1: 1-99 (mild calcification) * A2: 100-299 (moderate calcification) * A3: ≥300 (moderate to severe calcification)

Time frame
Baseline to 12 months
2

Number and Percentage of Participants With No Changes, Positive Changes, and Negative Changes in the Densitometric Spectrum of the Coronary Atherosclerotic Plaque Between Baseline and 12 Months

The densitometric spectrum of the plaque, as measured by PCCT, will be assessed based on the Hounsfield Unit (HU)-defined categories: * Lipidic plaque: \<30 HU * Fibro-lipidic plaque: 30-60 HU * Fibrotic plaque: 60-130 HU * Calcified plaque: \>130 HU

Time frame
Baseline to 12 months
3

Number and Percentage of Participants With No Changes, Positive Changes, and Negative Changes in the Degree of Coronary Artery Lumen Stenosis Between Baseline and 12 Months

The degree of coronary artery lumen stenosis, as measured by PCCT, will be assessed based on the Society of Cardiovascular Computed Tomography (SCCT)-defined categories: 1. Normal/Absence of Stenosis: 0% 2. Minimal: 1-24% 3. Mild: 25-49% 4. Moderate: 50-69% 5. Severe: 70-99% 5\. Occluded: 100%

Time frame
Baseline to 12 months
4

Change in HS Severity, as Measured by IHS4, From Baseline to 6 Months and 12 Months

IHS4 is a score used to assess the severity of HS. Determining IHS4 score requires counting nodules, abscesses and draining tunnels/sinus tracts. A score of 3 or less signifies mild HS, a score of 4 to 10 signifies moderate HS, and a score of 11 or higher signifies severe HS.

Time frame
Baseline to 6 months and 12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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