A Real-world Study of Patients With Hidradenitis Suppurativa and High Cardiovascular Risk or Esta… (NCT07454889) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Real-world Study of Patients With Hidradenitis Suppurativa and High Cardiovascular Risk or Established Coronary Plaque Treated With Secukinumab
34 participantsStarted 2026-05-31
Plain-language summary
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 can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Participants With Lack of Clinically Significant Progression of Coronary Atherosclerotic Plaque Between Baseline and 12 Months, as Measured by PCCT
. 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.