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Not yet recruiting NCT07690319

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

— Observational Hidradenitis Suppurativa

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hidradenitis Suppurativa. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Early Secukinumab Treatment in Moderate to Severe Hidradenitis Suppurativa Patients: Early Action Reduces Long-term Yield in Hidradenitis Suppurativa (EARLY HS 2)

Overview

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.

Primary outcome measures

  • Proportion of Patients Achieving 55% Reduction From Baseline in International Hidradenitis Suppurativa Severity Scoring System (IHS4-55) at 6 and 12 Months [Time frame: 6 and 12 months]
Secondary outcome measures (12)
  • Number and Percentage of Patients by Selected Demographic and Clinical Characteristics Overall and by Early and Late Treatment Group [Time frame: Baseline]
  • Duration of HS [Time frame: Baseline]
  • Mean Change From Baseline in IHS4 Score at 6 and 12 Months [Time frame: Baseline, 6 and 12 months]
  • Proportion of Patients Achieving 75% Reduction in IHS4 (IHS4-75) From Baseline at 6 and 12 Months [Time frame: 6 and 12 months]
  • Proportion of Patients Achieving 100% Reduction in IHS4 (IHS4-100) From Baseline at 6 and 12 Months [Time frame: 6 and 12 months]
  • Mean Change in Number of Inflammatory Abscesses, Nodules, and Active Tunnels From Baseline at 6 and 12 Months [Time frame: Baseline, 6 and 12 months]
  • Proportion of Patients Whose Disease Progresses From Baseline at 6 and 12 Months [Time frame: 6 and 12 months]
  • Mean Number of Flares From Baseline at 6 and 12 Months [Time frame: 6 and 12 months]
  • Mean Change in Pain From Baseline at 6 and 12 Months [Time frame: Baseline, 6 and 12 months]
  • Proportion of Patients Achieving ≥30% Reduction in Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS30) [Time frame: 6 and 12 months]
  • Proportion of Patients Who Required Surgery From Baseline at 6 and 12 Months [Time frame: 6 and 12 months]
  • Proportion of Patients Achieving a 5-point Reduction of Their Dermatology Life Quality Index (DLQI) Questionnaire From Baseline at 6 and 12 Months [Time frame: 6 and 12 months]

Eligibility criteria

Inclusion criteria

  • 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;
  • And at least one follow-up assessment at 6 or 12 months after index date.

Exclusion criteria

  • 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.

Other protocol-defined inclusion/exclusion criteria may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07690319 · CAIN457M2007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗