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NCT Number: NCT07690319

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: Baseline

    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
  2. Duration of HS

    Time frame: Baseline

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

    Time frame: Baseline, 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.

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

    Time frame: 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.

  5. Proportion of Patients Achieving 100% Reduction in IHS4 (IHS4-100) From Baseline at 6 and 12 Months

    Time frame: 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.

    IHS4-100 is defined as a proportion of patients achieving 100% reduction in IHS4 score at 6 and 12 months compared to baseline.

  6. 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

  7. Proportion of Patients Whose Disease Progresses From Baseline at 6 and 12 Months

    Time frame: 6 and 12 months

    Disease progression is defined as development of new tunnel(s) or development of new persistent HS lesions in an anatomical area not previously affected or increase in the number of persistent HS lesions in an affected anatomical region. Persistent lesions are defined as lesions sustained for ≥4 weeks.

  8. Mean Number of Flares From Baseline at 6 and 12 Months

    Time frame: 6 and 12 months

    Flare is defined as an increase of at least 25% in AN (abscess and inflammatory nodule) count with a minimum increase of 2 AN relative to baseline.

  9. Mean Change in Pain From Baseline at 6 and 12 Months

    Time frame: Baseline, 6 and 12 months

    Patient-reported Numeric Rating Scale (NRS) skin pain score at 6 and/or 12 months, as recorded.

    The Skin Pain NRS is a tool used to measure patient reported skin pain severity. Patients rate their worst skin pain over the past 24 hours on a scale from 0 (no pain) to 10 (worst pain imaginable).

  10. Proportion of Patients Achieving ≥30% Reduction in Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS30)

    Time frame: 6 and 12 months

    The Skin Pain NRS is a tool used to measure patient reported skin pain severity. Patients rate their worst skin pain over the past 24 hours on a scale from 0 (no pain) to 10 (worst pain imaginable). An NRS30 response is defined as a ≥30% reduction and ≥2-point decrease in skin pain score from baseline.

  11. Proportion of Patients Who Required Surgery From Baseline at 6 and 12 Months

    Time frame: 6 and 12 months

    Any HS-related surgery (e.g., STEEP, wide excision, incision and drainage, deroofing) between baseline and at 6 and/or 12 months, as reported.

  12. 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

    The DLQI is a questionnaire designed to measure the impact of skin disease on a patient's health-related quality of life. It contains 10 simple, self-administered items. Each item is scored on a 4-point scale (0 = not at all to 3 = very much). The total score ranges from 0 to 30, with higher scores indicating greater impairment in quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: EARLY-HS 2

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 8, 2026
Registry last updated
Jul 8, 2026

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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