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NCT Number: NCT05921994

Long Term Observational Study to Collect in a Real-world populatIon Data on the Treatment Pattern of secukinumAb in Adult Patients With Moderate to Severe Hidradenitis Suppurativa.

The purpose of this observational, prospective, non-interventional, multicenter, open-label, single arm study in Hidradenitis suppurativa (HS) is to assess the treatment pattern of secukinumab in a flexible dosing regimen and decision influencing factors for flexible dosing in a real-world population over 2 years.

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Key information

Conditions

Hidradenitis Suppurativa Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Freiburg im Breisgau, Baden-Wurttemberg, Germany

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About this study

The study will collect data from patients during routine secukinumab treatment and will be representative of the real-world patient population eligible for secukinumab treatment in Germany.

In order to attain widespread representation of health care practices related to the use of secukinumab in the approved indication of moderate to severe HS, a broad spectrum of dermatology practices and clinics who are treating patients with HS across Germany will be included.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients eligible for inclusion in this study have to fulfill all of the following criteria at enrollment:

  • Patients who provide written informed consent to participate in the study
  • Male and female patients with ≥18 years of age
  • Diagnosis of clinically unequivocal moderate to severe HS
  • Patients for whom a therapy with secukinumab is medically indicated
  • Documented decision for treatment with marketed secukinumab regardless of this noninterventional study
  • Treatment with secukinumab according to the latest version of SmPC
  • Initial treatment with marketed secukinumab planned for up to 1 week before the baseline visit

Exclusion criteria

Patients fulfilling any of the following criteria at enrollment are not eligible for inclusion in this study. No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients:

  • Patients who have any contraindications, such as a history of or active inflammatory bowel disease (Crohn´s disease, ulcerative colitis), and are not eligible for treatment with secukinumab according to the SmPC
  • Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the study participation
  • Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with secukinumab
  • Previous exposure to IL-17 inhibitors
  • For biologic-naïve patients, previous exposure to another biologic drug, such as anti-TNF-α inhibitors

Treatment and study plan

secukinumab

Other

Prospective observational study. There is no treatment allocation. Patients administered secukinumab by prescription and administered according to the SmPC.

Primary outcomes

  1. Proportion of patients receiving up-titration

    Time frame: Up to 24 months

    Proportion of patients receiving up-titration (q4w-to-q2w)

  2. Proportion of patients receiving down-titration

    Time frame: Up to 24 months

    Proportion of patients receiving down-titration (q2w-to-q4w)

  3. Time to up-titration and down-titration

    Time frame: Up to 2 years

    Time to up-titration and down-titration

  4. Duration of q4w treatment with secukinumab after dose reduction

    Time frame: Up to 2 years

    Duration of q4w treatment with secukinumab after dose reduction

  5. Proportion of patients who receive more than one up-and/or down titration

    Time frame: Up to 24 months

    Proportion of patients who receive more than one up-and/or down titration

  6. Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab

    Time frame: Up to 2 years

    Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab

  7. Number and type of surgical interventions

    Time frame: Up to 2 years

    Number and type of surgical interventions

    • minor and major surgical excision;
    • inpatient, outpatient

  8. Proportion of patients achieving 55% reduction in IHS4 (IHS4-55)

    Time frame: Up to 24 months

    The IHS4 is an exclusively physician-based, clinical scoring system for dynamic assessment of HS severity.

    HS severity is calculated based on the number of lesions multiplied by their respective score: the IHS4 score (points) = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + [number of draining tunnels (fistulae/sinuses) multiplied by 4]. A score of 3 or less signifies mild HS, a score of 4-10 signifies moderate HS and a score of 11 or higher signifies severe HS

  9. mean change of International Hidradenitis Suppurativa Severity Score System (IHS4)

    Time frame: Up to 24 months

    The IHS4 is an exclusively physician-based, clinical scoring system for dynamic assessment of HS severity.

    HS severity is calculated based on the number of lesions multiplied by their respective score: the IHS4 score (points) = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + [number of draining tunnels (fistulae/sinuses) multiplied by 4]. A score of 3 or less signifies mild HS, a score of 4-10 signifies moderate HS and a score of 11 or higher signifies severe HS

  10. Proportion of patients achieving a 5-point reduction of their Dermatology Life Quality Index (DLQI) questionnaire

    Time frame: Up to 24 months

    The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts. The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school.

    Each item has four response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment.

  11. Mean reduction of Abscesses and inflammatory nodules (AN) count

    Time frame: Up to 24 months

    Mean reduction of Abscesses and inflammatory nodules (AN) count

  12. Proportion of patients achieving a 30% reduction of pain Numerical Rating scale 30 (NRS30)

    Time frame: Up to 24 months

    The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). To assess this, the patient should concentrate on the pain that his/her skin lesions generate. The Patient's Global Assessment of Skin Pain - NRS will be completed by the subject electronically via a web-based application or in paper form.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Long Term observAtional, Prospective, Multicenter Study to Collect iN a Real-world populatIon Data on the treatMent Pattern of secukinumAb in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (HS) (ANIMA)

Acronym: ANIMA

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 28, 2023
Registry last updated
Jul 20, 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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