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. (ANIMA)

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Other: secukinumab

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Study Locations

• Germany
  • Aachen, Germany, 52064
    • Recruiting
    • Novartis Investigative Site
  • Ahaus, Germany, 48683
    • Recruiting
    • Novartis Investigative Site
  • Annaberg-Buchholz, Germany, 09456
    • Recruiting
    • Novartis Investigative Site
  • Bergen, Germany, 18528
    • Recruiting
    • Novartis Investigative Site
  • Berlin, Germany, 12159
    • Recruiting
    • Novartis Investigative Site
  • Berlin, Germany, 13595
    • Recruiting
    • Novartis Investigative Site
  • Berlin, Germany, 13507
    • Recruiting
    • Novartis Investigative Site
  • Berlin, Germany, 13086
    • Recruiting
    • Novartis Investigative Site
  • Bielefeld, Germany, 33647
    • Recruiting
    • Novartis Investigative Site
  • Bochum, Germany, 44791
    • Recruiting
    • Novartis Investigative Site
  • Brandenburg An Der Havel, Germany, 14776
    • Recruiting
    • Novartis Investigative Site
  • Bremen, Germany, 28359
    • Recruiting
    • Novartis Investigative Site
  • Bremen, Germany, 28219
    • Recruiting
    • Novartis Investigative Site
  • Buxtehude, Germany, 21614
    • Recruiting
    • Novartis Investigative Site
  • Chemnitz, Germany, 09113
    • Recruiting
    • Novartis Investigative Site
  • Chemnitz, Germany, 09117
    • Recruiting
    • Novartis Investigative Site
  • Delitzsch, Germany, 04509
    • Recruiting
    • Novartis Investigative Site
  • Dessau Rosslau, Germany, 06847
    • Recruiting
    • Novartis Investigative Site
  • Dortmund, Germany, 44137
    • Recruiting
    • Novartis Investigative Site
  • Dresden, Germany, 01067
    • Recruiting
    • Novartis Investigative Site
  • Dresden, Germany, 01309
    • Recruiting
    • Novartis Investigative Site
  • Duren, Germany, 52349
    • Recruiting
    • Novartis Investigative Site
  • Emsdetten, Germany, 48282
    • Recruiting
    • Novartis Investigative Site
  • Erlangen, Germany, 91054
    • Recruiting
    • Novartis Investigative Site
  • Falkenberg, Germany, 04895
    • Recruiting
    • Novartis Investigative Site
  • Falkensee, Germany, 14612
    • Recruiting
    • Novartis Investigative Site
  • Freising, Germany, 85354
    • Recruiting
    • Novartis Investigative Site
  • Geilenkirchen, Germany, 52511
    • Recruiting
    • Novartis Investigative Site
  • Gera, Germany, 07548
    • Recruiting
    • Novartis Investigative Site
  • Gernsbach, Germany, 76593
    • Recruiting
    • Novartis Investigative Site
  • Gladbeck, Germany, 45964
    • Recruiting
    • Novartis Investigative Site
  • Hamburg, Germany, 20246
    • Recruiting
    • Novartis Investigative Site
  • Hamburg, Germany, 20457
    • Recruiting
    • Novartis Investigative Site
  • Hamburg, Germany, 22549
    • Recruiting
    • Novartis Investigative Site
  • Hannover, Germany, 30159
    • Recruiting
    • Novartis Investigative Site
  • Hasfurt, Germany, 97437
    • Recruiting
    • Novartis Investigative Site
  • Haslach im Kinzigtal, Germany, 77716
    • Recruiting
    • Novartis Investigative Site
  • Hofgeismar, Germany, 34369
    • Recruiting
    • Novartis Investigative Site
  • Ilmenau, Germany, 98693
    • Recruiting
    • Novartis Investigative Site
  • Jena, Germany, 07743
    • Recruiting
    • Novartis Investigative Site
  • Juelich, Germany, 52428
    • Recruiting
    • Novartis Investigative Site
  • Karlsruhe, Germany, 76133
    • Recruiting
    • Novartis Investigative Site
  • Kempen, Germany, 47906
    • Recruiting
    • Novartis Investigative Site
  • Kiel, Germany, 24103
    • Recruiting
    • Novartis Investigative Site
  • Koeln, Germany, 51065
    • Recruiting
    • Novartis Investigative Site
  • Koeln, Germany, 50674
    • Recruiting
    • Novartis Investigative Site
  • Krefeld, Germany, 47798
    • Recruiting
    • Novartis Investigative Site
  • Kroepelin, Germany, 18236
    • Recruiting
    • Novartis Investigative Site
  • Kulmbach, Germany, 95326
    • Recruiting
    • Novartis Investigative Site
  • Lauf, Germany, 91207
    • Recruiting
    • Novartis Investigative Site
  • Leipzig, Germany, 04289
    • Recruiting
    • Novartis Investigative Site
  • Leipzig, Germany, 04207
    • Recruiting
    • Novartis Investigative Site
  • Lingen, Germany, 49809
    • Recruiting
    • Novartis Investigative Site
  • Luebeck, Germany, 23538
    • Recruiting
    • Novartis Investigative Site
  • Magdeburg, Germany, 39104
    • Recruiting
    • Novartis Investigative Site
  • Magdeburg, Germany, 39120
    • Recruiting
    • Novartis Investigative Site
  • Mainz, Germany, 55128
    • Recruiting
    • Novartis Investigative Site
  • Mainz, Germany, 55116
    • Recruiting
    • Novartis Investigative Site
  • Marburg, Germany, 35043
    • Recruiting
    • Novartis Investigative Site
  • Minden, Germany, 32429
    • Recruiting
    • Novartis Investigative Site
  • Moenchengladbach, Germany, 41063
    • Recruiting
    • Novartis Investigative Site
  • Muenchen, Germany, 81369
    • Recruiting
    • Novartis Investigative Site
  • Mönchengladbach, Germany, 41061
    • Recruiting
    • Novartis Investigative Site
  • Neuwied, Germany, 56564
    • Recruiting
    • Novartis Investigative Site
  • Nuernberg, Germany, 90402
    • Recruiting
    • Novartis Investigative Site
  • Nuernberg, Germany, 90419
    • Recruiting
    • Novartis Investigative Site
  • Oberasbach, Germany, 90522
    • Recruiting
    • Novartis Investigative Site
  • Oelde, Germany, 59302
    • Recruiting
    • Novartis Investigative Site
  • Oelsnitz, Germany, 09376
    • Recruiting
    • Novartis Investigative Site
  • Peitz, Germany, 03185
    • Recruiting
    • Novartis Investigative Site
  • Potsdam, Germany, 14469
    • Recruiting
    • Novartis Investigative Site
  • Remscheid, Germany, 42897
    • Recruiting
    • Novartis Investigative Site
  • Rheinstetten Moersch, Germany, 76287
    • Recruiting
    • Novartis Investigative Site
  • Selters, Germany, 56242
    • Recruiting
    • Novartis Investigative Site
  • Simmern, Germany, 55469
    • Recruiting
    • Novartis Investigative Site
  • Soest, Germany, 59494
    • Recruiting
    • Novartis Investigative Site
  • Stolberg, Germany, 52222
    • Recruiting
    • Novartis Investigative Site
  • Unna, Germany, 59423
    • Recruiting
    • Novartis Investigative Site
  • Wittlich, Germany, 54316
    • Recruiting
    • Novartis Investigative Site
  • Wuppertal, Germany, 42103
    • Recruiting
    • 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

patients, being treated for HS with secukinumab according to the summary of product characteristics (SmPC), after the approval of secukinumab has been granted in this indication.

Description

Inclusion Criteria:

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

1. Patients who provide written informed consent to participate in the study
2. Male and female patients with ≥18 years of age
3. Diagnosis of clinically unequivocal moderate to severe HS
4. Patients for whom a therapy with secukinumab is medically indicated
5. Documented decision for treatment with marketed secukinumab regardless of this noninterventional study
6. Treatment with secukinumab according to the latest version of SmPC
7. 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:

1. 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
2. Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the study participation
3. Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with secukinumab
4. Previous exposure to IL-17 inhibitors
5. For biologic-naïve patients, previous exposure to another biologic drug, such as anti-TNF-α inhibitors

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
secukinumab; Patients being treated for HS with secukinumab according to the summary of product characteristics (SmPC), after the approval of secukinumab has been granted in this indication.	Other: secukinumab; Prospective observational study. There is no treatment allocation. Patients administered secukinumab by prescription and administered according to the SmPC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients receiving up-titration	Proportion of patients receiving up-titration (q4w-to-q2w)	Up to 24 months
Proportion of patients receiving down-titration	Proportion of patients receiving down-titration (q2w-to-q4w)	Up to 24 months
Time to up-titration and down-titration	Time to up-titration and down-titration	Up to 2 years
Duration of q4w treatment with secukinumab after dose reduction	Duration of q4w treatment with secukinumab after dose reduction	Up to 2 years
Proportion of patients who receive more than one up-and/or down titration	Proportion of patients who receive more than one up-and/or down titration	Up to 24 months
Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab	Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab	Up to 2 years
Number and type of surgical interventions	Number and type of surgical interventions; minor and major surgical excision;; inpatient, outpatient	Up to 2 years
Proportion of patients achieving 55% reduction in IHS4 (IHS4-55)	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	Up to 24 months
mean change of International Hidradenitis Suppurativa Severity Score System (IHS4)	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	Up to 24 months
Proportion of patients achieving a 5-point reduction of their Dermatology Life Quality Index (DLQI) questionnaire	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.	Up to 24 months
Mean reduction of Abscesses and inflammatory nodules (AN) count	Mean reduction of Abscesses and inflammatory nodules (AN) count	Up to 24 months
Proportion of patients achieving a 30% reduction of pain Numerical Rating scale 30 (NRS30)	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.	Up to 24 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2023
• Primary Completion (Estimated): December 22, 2026
• Study Completion (Estimated): December 22, 2026

Study Registration Dates

• First Submitted: June 16, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: NIS; Germany; secukinumab; Hidradenitis suppurativa; HS
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis
• Other Study ID Numbers: CAIN457MDE01

Plan for Individual participant data (IPD)

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