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

NCT07454889

Not Yet RecruitingN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Hidradenitis Suppurativa

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.