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

Recruiting

• Conditions: Hidradenitis Suppurativa
• Interventions: Other: Secukinumab

• Registration Number: NCT06517732
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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).

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 Timeline

• Study First Submitted: 2024-07-18
• Study First Submitted QC: 2024-07-18
• Study First Posted: 2024-07-24
• Study Start: 2024-07-26
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-11
• Last Update Posted: 2025-01-14
• Primary Completion: 2026-06-28
• Study Completion: 2026-06-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Secukinumab	Secukinumab	Patients prescribed with secukinumab in the treatment of Hidradenitis Suppurativa

Primary Outcome Measures

Name	Time	Method
Proportion of patients achieving 55% reduction in IHS4 (IHS4-55)	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 Outcome Measures

Name	Time	Method
Mean change of nodule count	Month 6, month 12	Mean reduction of nodule count
Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab	12 months	Proportion of patients receiving Hidradenitis Suppurativa (HS)-specific concomitant treatments in combination with secukinumab
Time of initiation of concomitant medication	12 months	Time of initiation of concomitant medication (before or after the initiation of secukinumab).
Duration of discontinuation/pause of secukinumab treatment before surgery	12 months	Duration of discontinuation/pause of secukinumab treatment before surgery
Duration of discontinuation/pause of secukinumab treatment after surgery	12 months	Duration of discontinuation/pause of secukinumab treatment after surgery
Surgery outcome	12 months	Surgery outcome by type of wound healing, pain relief and discontinuation or continuation of secukinumab.
Lesion spread	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
Duration of treatment with concomitant medication	12 months	Duration of treatment with concomitant medication of secukinumab
Number, type, and outcome of surgical interventions	12 months	Number, type, and outcome of surgical interventions (minor and major surgical excision; inpatient, outpatient, or self-treatment at home)
Timepoint of and reason for surgical intervention	12 months	Timepoint of and reason for surgical intervention.
Proportion of patients achieving 75% reduction in IHS4 (IHS4-75) and 100% reduction in IHS4 (IHS4-100)	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.
Outcome of surgery and adverse events stratified by secukinumab management	12 months	Outcome of surgery (healing, pain relief) and adverse events (i.e., infections) stratified by secukinumab management (continuation or discontinuation).
Predictors of treatment response	12 months	Listing of predictors of treatment response

Trial Locations

Locations (1)

Novartis Investigative Site; 🇷🇺 Tula, Russian Federation