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.

Last Update: May 24, 2024

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)

ClinicalTrials.gov Identifier:

NCT05921994

Novartis Reference Number:CAIN457MDE01

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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. 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.

Condition

Hidradenitis Suppurativa

Overall Status

Recruiting

Number of Participants

600

Start Date

Aug 10, 2023

Completion Date

Dec 22, 2026

Gender

All

Age(s)

18 Years - 99 Years (Adult, Older Adult)

Interventions

Other

secukinumab

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

Eligibility Criteria

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 Location

Novartis Investigative Site

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Falkensee,14612,Germany

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Luebeck,23538,Germany

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Hasfurt,97437,Germany

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Nuernberg,90402,Germany

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Bielefeld,33647,Germany

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Kulmbach,95326,Germany

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Stolberg,52222,Germany

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Dresden,01307,Germany

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Bergen,18528,Germany

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Gladbeck,45964,Germany

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Minden,32429,Germany

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Kempen,47906,Germany

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Potsdam,14469,Germany

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Chemnitz,09117,Germany

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Lutherstadt Wittenberg,06886,Germany

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Freiburg,79068,Germany

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Bochum,44791,Germany

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Haslach im Kinzigtal,77716,Germany

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Nuernberg,90419,Germany

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Lauf,91207,Germany

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Unna,59423,Germany

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Dresden,01309,Germany

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Moenchengladbach,41063,Germany

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Berlin,12159,Germany

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Hamburg,20246,Germany

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Delitzsch,04509,Germany

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Kiel,24103,Germany

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Remscheid,42897,Germany

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Magdeburg,39104,Germany

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Freising,85354,Germany

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Oberasbach,90522,Germany

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Bonn,53105,Germany

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Hofgeismar,34369,Germany

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Duren,52349,Germany

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Leipzig,04207,Germany

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Wittlich,54316,Germany

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Monchengladbach,41061,Germany

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Berlin,13086,Germany

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Hamburg,20457,Germany

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Rheinstetten Moersch,76287,Germany

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Dessau Rosslau,06847,Germany

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Koeln,50674,Germany

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Geilenkirchen,52511,Germany

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Magdeburg,39120,Germany

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Oelde,59302,Germany

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Brandenburg An Der Havel,14776,Germany

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Ilmenau,98693,Germany

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Wuppertal,42103,Germany

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Emsdetten,48282,Germany

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Hamburg,22143,Germany

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Muenchen,81369,Germany

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Berlin,13507,Germany

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Selters,56242,Germany

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Dorsten,46282,Germany

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Koeln,51065,Germany

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Gelsenkirchen,45899,Germany

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Mainz,55116,Germany

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Aachen,52064,Germany

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Oelsnitz,09376,Germany

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Bremen,28219,Germany

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Jena,07743,Germany

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Erlangen,91054,Germany

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Leipzig,04289,Germany

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Hamburg,22549,Germany

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Neu Wulmstorf,21629,Germany

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Berlin,13595,Germany

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Simmern,55469,Germany

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Dortmund,44137,Germany

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Krefeld,47798,Germany

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Gera,07548,Germany

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Mainz,55128,Germany

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Ahaus,48683,Germany

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Juelich,52428,Germany

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Panketal,16341,Germany

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Buxtehude,21614,Germany

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Falkenberg,04895,Germany

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Lingen,49809,Germany

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Hannover,30159,Germany

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Neuwied,56564,Germany

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Berlin,14052,Germany

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Kroepelin,18236,Germany

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Soest,59494,Germany

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Dresden,01067,Germany

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Gernsbach,76593,Germany

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Marburg,35043,Germany

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Annaberg-Buchholz,09456,Germany

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Karlsruhe,76133,Germany

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Peitz,03185,Germany

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Chemnitz,09113,Germany

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