A Study of Early Secukinumab Treatment in Moderate to Severe Hidradenitis Suppurativa Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNovartis Pharmaceuticals

About this trial

The aim of this study is to evaluate the effectiveness of early treatment with secukinumab in patients with moderate-to-severe hidradenitis suppurativa (HS) and assess its impact on disease progression using data from multiple European data sources. All data will be sourced from existing non-interventional study primary data collection, registries, and hospital cohorts that captured information collected in routine clinical practice, prior to and independent of this study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with a documented diagnosis of HS (e.g., International Classification of Diseases, 10th Revision [ICD-10] code L73.2);

Age ≥18 years at index date;

Moderate-to-severe HS as per label;

Initiation of secukinumab treatment on or after the first HS diagnosis date;

Disqualifiers

Patients who had major HS-related surgery (Skin-tissue-sparing Excision with Electrosurgical Peeling [STEEP] or wide excision) in the 12 months prior to index date;

Patients participating in interventional clinical trials at index date.

Trial population

Adult patients with moderate-to-severe HS who initiated secukinumab treatment.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

186 Participants
are grouped into 2 trial groups
Group A: Early Treatment Group
Group B: Late Treatment Group

Trial outcomes

Primary outcomes

1

Proportion of Patients Achieving 55% Reduction From Baseline in International Hidradenitis Suppurativa Severity Scoring System (IHS4-55) at 6 and 12 Months

The International Hidradenitis Suppurativa Severity Scoring System (IHS4) is a validated measure of HS severity. Disease severity is calculated by weighting different lesion types as follows: the IHS4 score = (number of nodules × 1) + (number of abscesses × 2) + (number of draining tunnels \[fistulae/sinuses\] × 4). A score of ≤3 indicates mild disease, a score of 4-10 indicates moderate disease, and a score of ≥11 indicates severe disease. In this study, treatment response is assessed using IHS4-55, defined as a proportion of patients achieving ≥55% reduction in IHS4 score compared to baseline.

Time frame
6 and 12 months

Secondary outcomes

1

Number and Percentage of Patients by Selected Demographic and Clinical Characteristics Overall and by Early and Late Treatment Group

Demographics and clinical characteristics (subject to availability in the data sources) include: * Age category * Sex * Body mass index (BMI) category * Smoking status * Other medical conditions * Family history of HS * Year of HS diagnosis * Year of secukinumab initiation * Hurley stage * Number of tunnels, nodules, abscesses * Prior surgeries and procedures * Prior treatment

Time frame
Baseline
2

Duration of HS

Time frame
Baseline
3

Mean Change From Baseline in IHS4 Score at 6 and 12 Months

The IHS4 is a validated measure of HS severity. Disease severity is calculated by weighting different lesion types as follows: the IHS4 score = (number of nodules × 1) + (number of abscesses × 2) + (number of draining tunnels \[fistulae/sinuses\] × 4). A score of ≤3 indicates mild disease, a score of 4-10 indicates moderate disease, and a score of ≥11 indicates severe disease.

Time frame
Baseline, 6 and 12 months
4

Proportion of Patients Achieving 75% Reduction in IHS4 (IHS4-75) From Baseline at 6 and 12 Months

The IHS4 is a validated measure of HS severity. Disease severity is calculated by weighting different lesion types as follows: the IHS4 score = (number of nodules × 1) + (number of abscesses × 2) + (number of draining tunnels \[fistulae/sinuses\] × 4). A score of ≤3 indicates mild disease, a score of 4-10 indicates moderate disease, and a score of ≥11 indicates severe disease. IHS4-75 is defined as a proportion of patients achieving ≥ 75% reduction in IHS4 score at 6 and 12 months compared to baseline.

Time frame
6 and 12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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