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

NCT07454889 | Not Yet Recruiting

• 1 other identifier: CAIN457MIT04
• Study Type: observational
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Hidradenitis Suppurativa

Keywords

Coronary Plaque; Cardiovascular Risk

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  Baseline to 12 months

• Change in HS Severity, as Measured by IHS4, From Baseline to 6 Months and 12 Months

  Baseline to 6 months and 12 months

• Percentage Change in Total Coronary Atherosclerotic Plaque Volume Between Baseline and 12 Months, as Assessed by PCCT

  Baseline to 12 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 6, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share