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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.

NCT ID: NCT05921994

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

425 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-10

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hidradenitis Suppurativa

Keywords

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Hidradenitis suppurativa HS secukinumab Germany NIS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

secukinumab

Intervention Type OTHER

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

Interventions

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secukinumab

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Freiburg im Breisgau, Baden-Wurttemberg, Germany

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Kulmbach, Bavaria, Germany

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Lauf an der Pegnitz, Bavaria, Germany

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Hamburg, Hamburg, Germany

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Lingen Ems, Lower Saxony, Germany

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Kröpelin, Mecklenburg-Vorpommern, Germany

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Krefeld, North Rhine-Westphalia, Germany

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Mainz, Rhineland-Palatinate, Germany

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Dresden, Saxony, Germany

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Leipzig, Saxony, Germany

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Leipzig, Saxony, Germany

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Wittenberg, Saxony-Anhalt, Germany

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Aachen, , Germany

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Ahaus, , Germany

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Annaberg-Buchholz, , Germany

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Bad Steben, , Germany

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Baden-Baden, , Germany

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Bergen, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Bielefeld, , Germany

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Bochum, , Germany

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Bonn, , Germany

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Brandenburg, , Germany

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Bremen, , Germany

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Buxtehude, , Germany

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Bückeburg, , Germany

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Chemnitz, , Germany

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Chemnitz, , Germany

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Cologne, , Germany

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Delitzsch, , Germany

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Dessau, , Germany

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Dorsten, , Germany

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Dortmund, , Germany

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Dresden, , Germany

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Düren, , Germany

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Emsdetten, , Germany

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Erlangen, , Germany

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Falkenberg, , Germany

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Falkensee, , Germany

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Freising, , Germany

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Geilenkirchen, , Germany

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Gera, , Germany

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Gernsbach, , Germany

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Gladbeck, , Germany

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Großenhain, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Hanover, , Germany

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Hasfurt, , Germany

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Haslach im Kinzigtal, , Germany

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Hofgeismar, , Germany

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Jena, , Germany

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Jülich, , Germany

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Karlsruhe, , Germany

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Kempen, , Germany

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Lübeck, , Germany

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Magdeburg, , Germany

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Magdeburg, , Germany

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Mainz, , Germany

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Marburg, , Germany

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Minden, , Germany

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Mönchengladbach, , Germany

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Neu Wulmstorf, , Germany

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Nuremberg, , Germany

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Nuremberg, , Germany

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Oberasbach, , Germany

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Oelde, , Germany

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Panketal, , Germany

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Peitz, , Germany

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Potsdam, , Germany

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Remscheid, , Germany

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Rheinstetten Moersch, , Germany

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Selters, , Germany

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Simmern, , Germany

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Soest, , Germany

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Stolberg, , Germany

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Unna, , Germany

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Wittlich, , Germany

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Wuppertal, , Germany

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Countries

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Germany

Other Identifiers

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CAIN457MDE01

Identifier Type: -

Identifier Source: org_study_id