A Real-world Study of Patients With Hidradenitis Suppurativa and High Cardiovascular Risk or Established Coronary Plaque Treated With Secukinumab
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hidradenitis Suppurativa. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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
Primary outcome 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]
Secondary outcome measures (5)
- 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]
- 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]
- 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]
- 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]
- Percentage Change in Total Coronary Atherosclerotic Plaque Volume Between Baseline and 12 Months, as Assessed by PCCT [Time frame: Baseline to 12 months]
Eligibility criteria
Inclusion criteria
- 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.
- Participants eligible for coronary imaging by Photon-Counting Computed Tomography (PCCT) based on at least one of the following:
- Evidence of coronary atherosclerotic plaque previously identified by imaging and receipt of stable, guideline-directed medical therapy.
- Clinical indication as determined by a cardiologist.
- 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).
- Signed Informed Consent Form (ICF), obtained from the participant or a legally authorized representative, prior to any study-related activities.
Exclusion criteria
- 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).
- Contraindications to perform PCCT (including allergies to contrast).
- Other autoimmune systemic diseases or active neoplastic diseases.
- Known history of Moderate to severe anemia.
- Congestive Heart Failure (New York Heart Association \[NYHA\] Class III-IV).
- Pregnant or lactating women.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07454889 · CAIN457MIT04