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)

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)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Other: Secukinumab

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.

• Study Type: Observational
• Enrollment (Actual): 107

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Secukinumab; Patients prescribed with secukinumab in the treatment of Hidradenitis Suppurativa	Other: Secukinumab; This is an observational study. There is no treatment allocation. The decision to initiate secukinumab will be based solely on clinical judgement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months
Time of initiation of concomitant medication	Time of initiation of concomitant medication (before or after the initiation of secukinumab).	12 months
Duration of treatment with concomitant medication	Duration of treatment with concomitant medication of secukinumab	12 months
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)	12 months
Timepoint of and reason for surgical intervention	Timepoint of and reason for surgical intervention.	12 months
Duration of discontinuation/pause of secukinumab treatment before surgery	Duration of discontinuation/pause of secukinumab treatment before surgery	12 months
Duration of discontinuation/pause of secukinumab treatment after surgery	Duration of discontinuation/pause of secukinumab treatment after surgery	12 months
Surgery outcome	Surgery outcome by type of wound healing, pain relief and discontinuation or continuation of secukinumab.	12 months
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).	12 months
Predictors of treatment response	Listing of predictors of treatment response	12 months
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.	Month 6, month 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	Baseline, month 6, month 12
Mean change of nodule count	Mean reduction of nodule count	Month 6, month 12

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 18, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: secukinumab; HS; Hidradenitis Suppurativa; real-world data
• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Hidradenitis; Skin and Connective Tissue Diseases; Hidradenitis Suppurativa; secukinumab
• Other Study ID Numbers: CAIN457MRU01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO