CClinicalTrials.gg
Active, not recruitingNCT06517732ANIMA-RUpdated Apr 16, 2026

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

An observational study in Hidradenitis Suppurativa, sponsored by Novartis Pharmaceuticals. Active, not recruiting at 19 sites in Russia. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-04-16.

Sponsored by Novartis Pharmaceuticals · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
107
Ages
18 Years to 99 Years
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Hidradenitis Suppurativa

Keywords

  • Hidradenitis Suppurativa
  • HS
  • real-world data
  • secukinumab
03

In context

Hidradenitis Suppurativa

277 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.

This study's enrollment of 107 is below the median of 142 across 69 observational studies indexed under Hidradenitis Suppurativa.

Browse Hidradenitis Suppurativa studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with moderate to severe Hidradenitis Suppurativa commencing treatment with secukinumab

Inclusion criteria

  1. Patients who provide written informed consent form (ICF) to participate in the study.
  2. Male and female.
  3. ≥ 18 years old.
  4. Diagnosis of moderate or severe HS (Hurley stage and IHS4).
  5. Patient who initiated treatment with secukinumab no longer than 4 weeks prior to written ICF.
  6. 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

Exclusion Criteria:

  1. Any medical or psychological condition that may prevent the study participation, based on practitioners' decision-making.
  2. Participation in an ongoing clinical trial.
  3. Known or suspected severe hypersensitivity for secukinumab, formulation excipients, or injection device components (i.e., latex).
  4. Clinically significant infection exacerbation, including active tuberculosis.
  5. Patients with active inflammatory bowel disease (IBD).
  6. Age \<18 years.
  7. Pregnancy and breastfeeding.
  8. Patients who received any vaccine within 4 weeks prior to secukinumab initiation.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
107 participants (actual)
Patient registry
No

Groups and cohorts

  • Secukinumab

    Patients prescribed with secukinumab in the treatment of Hidradenitis Suppurativa

    Other: Secukinumab

Interventions

  • OtherSecukinumab

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

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: 12 months

Secondary outcomes

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

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

    Time frame: 12 months

  2. Time of initiation of concomitant medication

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

    Time frame: 12 months

  3. Duration of treatment with concomitant medication

    Duration of treatment with concomitant medication of secukinumab

    Time frame: 12 months

  4. Number, type, and outcome of surgical interventions

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

    Time frame: 12 months

  5. Timepoint of and reason for surgical intervention

    Timepoint of and reason for surgical intervention.

    Time frame: 12 months

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

    Duration of discontinuation/pause of secukinumab treatment before surgery

    Time frame: 12 months

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

    Duration of discontinuation/pause of secukinumab treatment after surgery

    Time frame: 12 months

  8. Surgery outcome

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

    Time frame: 12 months

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

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

    Time frame: 12 months

  10. Predictors of treatment response

    Listing of predictors of treatment response

    Time frame: 12 months

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

    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.

    Time frame: Month 6, month 12

  12. Lesion spread

    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

    Time frame: Baseline, month 6, month 12

  13. Mean change of nodule count

    Mean reduction of nodule count

    Time frame: Month 6, month 12

07

Study locations

19 sites
  • Novartis Investigative Site
    Izhevsk, 426039, Russia
  • Novartis Investigative Site
    Kaliningrad, 236016, Russia
  • Novartis Investigative Site
    Kaliningrad, 236029, Russia
  • Novartis Investigative Site
    Kazan', 420012, Russia
  • Novartis Investigative Site
    Kemerovo, 650025, Russia
  • Novartis Investigative Site
    Krasnodar, 350020, Russia
  • Novartis Investigative Site
    Moscow, 107076, Russia
  • Novartis Investigative Site
    Moscow, 119881, Russia
  • Novartis Investigative Site
    Moscow, 123182, Russia
  • Novartis Investigative Site
    Moscow, 129110, Russia
  • Novartis Investigative Site
    Nizhny Novgorod, 603950, Russia
  • Novartis Investigative Site
    Penza, 440052, Russia
  • Novartis Investigative Site
    Saint Petersburg, 197022, Russia
  • Novartis Investigative Site
    Samara, 443079, Russia
  • Novartis Investigative Site
    Saratov, 410028, Russia
  • Novartis Investigative Site
    Stavropol, 355020, Russia
  • Novartis Investigative Site
    Tula, 300053, Russia
  • Novartis Investigative Site
    Ufa, 450010, Russia
  • Novartis Investigative Site
    Yakutsk, 677000, Russia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06517732
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Jul 24, 2024
Start date
Jul 26, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Apr 16, 2026

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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