A Real-world Study of Patients With Hidradenitis Suppurativa and High Cardiovascular Risk or Established Coronary Plaque Treated With Secukinumab
Hidradenitis Suppurativa
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Observational
- Phase
- Not applicable / not listed
- Age range
- 18 years - 75 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 34 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion criteria:
1. Adult participants aged ≥18 and ≤75 years.
2. Diagnosis of moderate-to-severe HS (International Hidradenitis Suppurativa Severity Score System \[IHS4\] ≥4).
3. Taking or planning to take secukinumab according to standard of care.
4. Participants eligible for coronary imaging by Photon-Counting Computed Tomography (PCCT) based on at least one of the following:
1. Evidence of coronary atherosclerotic plaque previously identified by imaging and receipt of stable, guideline-directed medical therapy.
2. Clinical indication as determined by a cardiologist.
3. Very high risk of developing cardiovascular diseases according to the Systematic Coronary Risk Evaluation 2 (SCORE2) and Systematic Coronary Risk Evaluation 2 - Older Persons (SCORE2-OP) risk models for moderate risk European regions (score ≥7.5% for participants \<50 years old, score ≥10% for participants 50-69 years old, and score ≥15% for participants ≥70 years old).
5. Signed Informed Consent Form (ICF), obtained from the participant or a legally authorized representative, prior to any study-related activities.
Exclusion criteria:
1. 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.
2. Use of investigational cardiovascular or anti-inflammatory drugs.
3. Use of any other investigational drugs.
4. Chronic Kidney Disease (estimated Glomerular Filtration Rate \[eGFR\] \<30 mL/min).
5. Contraindications to perform PCCT (including allergies to contrast).
6. Other autoimmune systemic diseases or active neoplastic diseases.
7. Known history of Moderate to severe anemia.
8. Congestive Heart Failure (New York Heart Association \[NYHA\] Class III-IV).
9. Pregnant or lactating women.
Study 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.
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not reported
- Masking
- Not reported
Secukinumab Cohort
Adult participants with a confirmed diagnosis of moderate-to-severe HS and either a very high cardiovascular risk with no detectable plaque at baseline or a documented coronary atherosclerotic plaque, who are initiating or receiving secukinumab as part of routine clinical care.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Proportion of Participants With Lack of Clinically Significant Progression of Coronary Atherosclerotic Plaque Between Baseline and 12 Months, as Measured by PCCT
Time frame: Baseline to 12 months
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.
Secondary measures
Number and Percentage of Participants With No Changes, Positive Changes, and Negative Changes in Coronary Artery Calcium (CAC) Score Between Baseline and 12 Months
Time frame: Baseline to 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)
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
Time frame: Baseline to 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
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
Time frame: Baseline to 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%
Change in HS Severity, as Measured by IHS4, From Baseline to 6 Months and 12 Months
Time frame: 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.
Percentage Change in Total Coronary Atherosclerotic Plaque Volume Between Baseline and 12 Months, as Assessed by PCCT
Time frame: Baseline to 12 months
Not reported in this registry record.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (0)
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No locations are listed. Use the official study contact.
Study team and timeline
- Lead sponsor
- Novartis Pharmaceuticals
- Study start
- Dec 31, 2026 Estimated
- Primary completion
- Oct 30, 2027 Estimated
- Study completion
- Oct 30, 2027 Estimated
- First posted
- Mar 6, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
12 Months-observation of Patients Treated for Hidradenitis Suppurativa, With High Cardiovascular Risk or Established Coronary Plaque: A Prospective Monocentric Study - the HOPE Study
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026