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.

Hidradenitis Suppurativa Clinical Trial

— ANIMA  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05921994
• Other study ID #: CAIN457MDE01
• Status: Recruiting
• Start date: August 10, 2023
• Est. completion date: December 22, 2026

Study information

• Verified date: May 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 22, 2026
• Est. primary completion date: December 22, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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-a inhibitors

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Other:
• secukinumab
Prospective observational study. There is no treatment allocation. Patients administered secukinumab by prescription and administered according to the SmPC.

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Aachen
Germany	Novartis Investigative Site	Ahaus
Germany	Novartis Investigative Site	Annaberg-Buchholz
Germany	Novartis Investigative Site	Bergen
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bielefeld
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Brandenburg An Der Havel
Germany	Novartis Investigative Site	Bremen
Germany	Novartis Investigative Site	Bremen
Germany	Novartis Investigative Site	Buxtehude
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Delitzsch
Germany	Novartis Investigative Site	Dessau Rosslau
Germany	Novartis Investigative Site	Dorsten
Germany	Novartis Investigative Site	Dortmund
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Duren
Germany	Novartis Investigative Site	Emsdetten
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Falkenberg
Germany	Novartis Investigative Site	Falkensee
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Freising
Germany	Novartis Investigative Site	Geilenkirchen
Germany	Novartis Investigative Site	Gelsenkirchen
Germany	Novartis Investigative Site	Gera
Germany	Novartis Investigative Site	Gernsbach
Germany	Novartis Investigative Site	Gladbeck
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Hasfurt
Germany	Novartis Investigative Site	Haslach im Kinzigtal
Germany	Novartis Investigative Site	Hofgeismar
Germany	Novartis Investigative Site	Ilmenau
Germany	Novartis Investigative Site	Jena
Germany	Novartis Investigative Site	Juelich
Germany	Novartis Investigative Site	Karlsruhe
Germany	Novartis Investigative Site	Kempen
Germany	Novartis Investigative Site	Kiel
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Krefeld
Germany	Novartis Investigative Site	Kroepelin
Germany	Novartis Investigative Site	Kulmbach
Germany	Novartis Investigative Site	Lauf
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Lingen
Germany	Novartis Investigative Site	Luebeck
Germany	Novartis Investigative Site	Magdeburg
Germany	Novartis Investigative Site	Magdeburg
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Marburg
Germany	Novartis Investigative Site	Minden
Germany	Novartis Investigative Site	Moenchengladbach
Germany	Novartis Investigative Site	Mönchengladbach
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Neu Wulmstorf
Germany	Novartis Investigative Site	Neuwied
Germany	Novartis Investigative Site	Nuernberg
Germany	Novartis Investigative Site	Nuernberg
Germany	Novartis Investigative Site	Oberasbach
Germany	Novartis Investigative Site	Oelde
Germany	Novartis Investigative Site	Oelsnitz
Germany	Novartis Investigative Site	Peitz
Germany	Novartis Investigative Site	Potsdam
Germany	Novartis Investigative Site	Remscheid
Germany	Novartis Investigative Site	Rheinstetten Moersch
Germany	Novartis Investigative Site	Selters
Germany	Novartis Investigative Site	Simmern
Germany	Novartis Investigative Site	Soest
Germany	Novartis Investigative Site	Stolberg
Germany	Novartis Investigative Site	Unna
Germany	Novartis Investigative Site	Wittlich
Germany	Novartis Investigative Site	Wuppertal

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients receiving up-titration	Proportion of patients receiving up-titration (q4w-to-q2w)	Up to 24 months
Primary	Proportion of patients receiving down-titration	Proportion of patients receiving down-titration (q2w-to-q4w)	Up to 24 months
Primary	Time to up-titration and down-titration	Time to up-titration and down-titration	Up to 2 years
Primary	Duration of q4w treatment with secukinumab after dose reduction	Duration of q4w treatment with secukinumab after dose reduction	Up to 2 years
Primary	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
Primary	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
Primary	Number and type of surgical interventions	Number and type of surgical interventions; minor and major surgical excision; inpatient, outpatient	Up to 2 years
Primary	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
Primary	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
Primary	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
Primary	Mean reduction of Abscesses and inflammatory nodules (AN) count	Mean reduction of Abscesses and inflammatory nodules (AN) count	Up to 24 months
Primary	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