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NCT Number: NCT06517732

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) in Routine Clinical Practice in the Russian Federation

ANIMA-R is an observational, prospective, non-interventional, multicenter study to assess real-world effectiveness of secukinumab in the treatment of Hidradenitis Suppurativa (HS).

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This study is active but is not currently recruiting participants.

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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, Izhevsk, Russia

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About this study

The index date will be the date of secukinumab initiation. During the study, data will be collected from patients receiving routine secukinumab treatment, which is representative of the actual patient population.

The attending physician will decide whether to prescribe secukinumab based on the approved instructions for medical use in a routine clinical setting, regardless of the patient's participation in a non-interventional study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who provide written informed consent form (ICF) to participate in the study.
  • Male and female.
  • ≥ 18 years old.
  • Diagnosis of moderate or severe HS (Hurley stage and IHS4).
  • Patient who initiated treatment with secukinumab no longer than 4 weeks prior to written ICF.
  • Decision for secukinumab prescription was made by the attending physician according to the approved national label during routine clinical practice, regardless of study participation.

Exclusion criteria

  • Any medical or psychological condition that may prevent the study participation, based on practitioners' decision-making.
  • Participation in an ongoing clinical trial.
  • Known or suspected severe hypersensitivity for secukinumab, formulation excipients, or injection device components (i.e., latex).
  • Clinically significant infection exacerbation, including active tuberculosis.
  • Patients with active inflammatory bowel disease (IBD).
  • Age <18 years.
  • Pregnancy and breastfeeding.
  • Patients who received any vaccine within 4 weeks prior to secukinumab initiation.

Treatment and study plan

secukinumab

Other

This is an observational study. There is no treatment allocation. The decision to initiate secukinumab will be based solely on clinical judgement.

Primary outcomes

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

    Time frame: 12 months

    The International Hidradenitis Suppurativa Severity Scoring System (IHS4) allows for a dynamic assessment of the disease severity both in clinical studies and in real-world clinical setting. The IHS4 is determined by counting nodules, abscesses, and draining tunnels (fistulae/sinuses). IHS4 (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 lower indicates a mild stage of hidradenitis suppurativa, a score of 4-10 indicates a moderate stage, and a score of 11 or higher indicates a severe stage of the disease. The IHS4 severity scoring system assumes that the presence of a draining tunnel (fistula/sinus) is sufficient to classify a case as at least moderate.

Secondary outcomes

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

    Time frame: 12 months

    Proportion of patients receiving Hidradenitis Suppurativa (HS)-specific concomitant treatments in combination with secukinumab

  2. Time of initiation of concomitant medication

    Time frame: 12 months

    Time of initiation of concomitant medication (before or after the initiation of secukinumab).

  3. Duration of treatment with concomitant medication

    Time frame: 12 months

    Duration of treatment with concomitant medication of secukinumab

  4. Number, type, and outcome of surgical interventions

    Time frame: 12 months

    Number, type, and outcome of surgical interventions (minor and major surgical excision; inpatient, outpatient, or self-treatment at home)

  5. Timepoint of and reason for surgical intervention

    Time frame: 12 months

    Timepoint of and reason for surgical intervention.

  6. Duration of discontinuation/pause of secukinumab treatment before surgery

    Time frame: 12 months

    Duration of discontinuation/pause of secukinumab treatment before surgery

  7. Duration of discontinuation/pause of secukinumab treatment after surgery

    Time frame: 12 months

    Duration of discontinuation/pause of secukinumab treatment after surgery

  8. Surgery outcome

    Time frame: 12 months

    Surgery outcome by type of wound healing, pain relief and discontinuation or continuation of secukinumab.

  9. Outcome of surgery and adverse events stratified by secukinumab management

    Time frame: 12 months

    Outcome of surgery (healing, pain relief) and adverse events (i.e., infections) stratified by secukinumab management (continuation or discontinuation).

  10. Predictors of treatment response

    Time frame: 12 months

    Listing of predictors of treatment response

  11. Proportion of patients achieving 75% reduction in IHS4 (IHS4-75) and 100% reduction in IHS4 (IHS4-100)

    Time frame: Month 6, month 12

    The International Hidradenitis Suppurativa Severity Scoring System (IHS4) allows for a dynamic assessment of the disease severity both in clinical studies and in real-world clinical setting. The IHS4 is determined by counting nodules, abscesses, and draining tunnels (fistulae/sinuses). IHS4 (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 lower indicates a mild stage of hidradenitis suppurativa, a score of 4-10 indicates a moderate stage, and a score of 11 or higher indicates a severe stage of the disease. The IHS4 severity scoring system assumes that the presence of a draining tunnel (fistula/sinus) is sufficient to classify a case as at least moderate.

  12. Lesion spread

    Time frame: Baseline, month 6, month 12

    Lesion spread (defined as total abscess and inflammatory nodule count (AN) or draining fistula in a body region not seen at baseline) assessed by number, type, and localization of HS lesions

  13. Mean change of nodule count

    Time frame: Month 6, month 12

    Mean reduction of nodule count

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Prospective, Observational, 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) in Routine Clinical Practice in the Russian Federation (ANIMA-R)

Acronym: ANIMA-R

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2024
Registry last updated
Apr 16, 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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