A Study of Early Secukinumab Treatment in Moderate to Severe Hidradenitis Suppurativa Patients
NCT07690319
Bacterial Infections, Bacterial Infections and Mycoses
View Trial DetailsNCT Number: NCT07454889
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
Trial opening soon.
Get Notified18 year–75 year
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline to 12 months
Lack of clinically significant progression is defined as follows:
Time frame: 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:
Time frame: 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:
Time frame: 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:
Time frame: 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.
Time frame: Baseline to 12 months
Contact information is provided by the study sponsor or research team.
Novartis Pharmaceuticals
Industry
12 Months-observation of Patients Treated for Hidradenitis Suppurativa, With High Cardiovascular Risk or Established Coronary Plaque: A Prospective Monocentric Study - the HOPE Study
Acronym: HOPE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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