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 updated: January 12, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rosacea

Hidradenitis Suppurativa

Scalp Disorders

Treatment

secukinumab

Clinical Study ID

NCT05921994
CAIN457MDE01
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 thisnoninterventional 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 thebaseline visit

Exclusion

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 inflammatorybowel disease (Crohn´s disease, ulcerative colitis), and are not eligible fortreatment with secukinumab according to the SmPC

  2. Any medical or psychological condition in the treating physician's opinion which mayprevent the patient from the study participation

  3. Simultaneous participation in any investigational trial or simultaneousparticipation in another Novartis-sponsored non-interventional study withsecukinumab

  4. Previous exposure to IL-17 inhibitors

  5. For biologic-naïve patients, previous exposure to another biologic drug, such asanti-TNF-α inhibitors

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: secukinumab
Phase:
Study Start date:
August 10, 2023
Estimated Completion Date:
December 22, 2026

Study 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.

Connect with a study center

  • Novartis Investigative Site

    Aachen, 52064
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Ahaus, 48683
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Annaberg-Buchholz, 09456
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Augsburg, 86150
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Bad Steben, 95138
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Baden-Baden, 76530
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Bergen, 18528
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Berlin, 12159
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Bielefeld, 33647
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Bochum, 44791
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Bonn, 53105
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Brandenburg An Der Havel, 14776
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Bremen, 28359
    Germany

    Completed

  • Novartis Investigative Site

    Bueckeburg, 31675
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Buxtehude, 21614
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Chemnitz, 09117
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Delitzsch, 04509
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Dessau Rosslau, 06847
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Dorsten, 46282
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Dortmund, 44137
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Dresden, 01309
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Duren, 52349
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Emsdetten, 48282
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Erlangen, 91054
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Falkenberg, 04895
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Falkensee, 14612
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Freiburg, 79068
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Freising, 85354
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Geilenkirchen, 52511
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Gelsenkirchen, 45899
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Gera, 07548
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Gernsbach, 76593
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Giessen, 35385
    Germany

    Site Not Available

  • Novartis Investigative Site

    Gladbeck, 45964
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Grossenhain, 01558
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Hamburg, 20457
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Hannover, 30159
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Hasfurt, 97437
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Haslach im Kinzigtal, 77716
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Hofgeismar, 34369
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Ilmenau, 98693
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Jena, 07743
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Juelich, 52428
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Karlsruhe, 76133
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Kempen, 47906
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Kiel, 24103
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Koeln, 51065
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Krefeld, 47798
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Kroepelin, 18236
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Kronach, 96317
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Kulmbach, 95326
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Lauf, 91207
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Leipzig, 04207
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Lingen, 49809
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Luebeck, 23538
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Lutherstadt Wittenberg, 06868
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Magdeburg, 39120
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Mainz, 55116
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Marburg, 35043
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Minden, 32429
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Moenchengladbach, 41063
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Monchengladbach, 41061
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Muenchen, 81369
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Mönchengladbach, 41061
    Germany

    Site Not Available

  • Novartis Investigative Site

    Neu Wulmstorf, 21629
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Neuss, 41460
    Germany

    Site Not Available

  • Novartis Investigative Site

    Neuwied, 56564
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Nuernberg, 90419
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Oberasbach, 90522
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Oelde, 59302
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Oelsnitz, 09376
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Panketal, 16341
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Peitz, 03185
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Potsdam, 14469
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Remscheid, 42897
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Rheinstetten Moersch, 76287
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Schweinfurt, 97421
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Selters, 56242
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Simmern, 55469
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Soest, 59494
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Stolberg, 52222
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Unna, 59423
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Vechta, 49377
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Wittlich, 54316
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Wuppertal, 42103
    Germany

    Active - Recruiting

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