Hidradenitis SuppurativaHOPENCT07454889
A Real-world Study of Patients With Hidradenitis Suppurativa and High Cardiovascular Risk or Established Coronary Plaque Treated With Secukinumab
An observational study of Hidradenitis Suppurativa, run by Novartis Pharmaceuticals.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hidradenitis Suppurativa
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2026to 31 Mar 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- Known history of Moderate to severe anemia.
- Congestive Heart Failure (New York Heart Association [NYHA] Class III-IV).
- Pregnant or lactating women.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
About this study
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
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
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Coronary Plaque, Cardiovascular Risk
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 months
Secondary outcomes (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
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)
Measured: 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
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
Measured: 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
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:
- Normal/Absence of Stenosis: 0%
- Minimal: 1-24%
- Mild: 25-49%
- Moderate: 50-69%
- Severe: 70-99%
- Occluded: 100%
Measured: Baseline to 12 months
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.
Measured: Baseline to 6 months and 12 months
Percentage Change in Total Coronary Atherosclerotic Plaque Volume Between Baseline and 12 Months, as Assessed by PCCT
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start30 Oct 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454889
- Sponsor's protocol ID
- CAIN457MIT04
- Acronym
- HOPE
- Status last verified
- Sep 2026
- First submitted
- 3 Mar 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Individual data sharing
- No