A Real-world Study of Patients With Hidradenitis Suppurativa and High Cardiovascular Risk or Established Coronary Plaque Treated With Secukinumab
Hidradenitis Suppurativa
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- Observacional
- Fase
- No aplica / no indicada
- Rango de edad
- 18 años - 75 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 34 Estimado
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Acerca de la investigación
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
¿Quién podría participar?
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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.
Población del estudio
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.
Entiende la evaluación inicialTratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No informado
- Enmascaramiento
- No informado
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.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Proportion of Participants With Lack of Clinically Significant Progression of Coronary Atherosclerotic Plaque Between Baseline and 12 Months, as Measured by PCCT
Plazo: Baseline to 12 months
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.
Medidas secundarias
Number and Percentage of Participants With No Changes, Positive Changes, and Negative Changes in Coronary Artery Calcium (CAC) Score Between Baseline and 12 Months
Plazo: Baseline to 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)
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
Plazo: Baseline to 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
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
Plazo: Baseline to 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:
1. Normal/Absence of Stenosis: 0%
2. Minimal: 1-24%
3. Mild: 25-49%
4. Moderate: 50-69%
5. Severe: 70-99%
5\. Occluded: 100%
Change in HS Severity, as Measured by IHS4, From Baseline to 6 Months and 12 Months
Plazo: 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.
Percentage Change in Total Coronary Atherosclerotic Plaque Volume Between Baseline and 12 Months, as Assessed by PCCT
Plazo: Baseline to 12 months
No informado en este registro.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (0)
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No hay centros indicados. Usa el contacto oficial del estudio.
Equipo y fechas
- Patrocinador principal
- Novartis Pharmaceuticals
- Inicio del estudio
- 31 dic 2026 Estimado
- Finalización primaria
- 30 oct 2027 Estimado
- Finalización del estudio
- 30 oct 2027 Estimado
- Primera publicación
- 6 mar 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
12 Months-observation of Patients Treated for Hidradenitis Suppurativa, With High Cardiovascular Risk or Established Coronary Plaque: A Prospective Monocentric Study - the HOPE Study
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026