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

Starting soon

Conditions studied: Hidradenitis Suppurativa

In brief

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

Key facts

Study ID

NCT07454889

Run by

Novartis Pharmaceuticals

People needed

34

Starts

2026-07-31

Expected to finish

2027-03-31

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

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