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 28, 2026
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Hidradenitis Suppurativa

Scalp Disorders

Rosacea

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: 425
Treatment Group(s): 1
Primary Treatment: secukinumab
Phase:
Study Start date:
August 10, 2023
Estimated Completion Date:
March 31, 2027

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

    Freiburg, Baden-Wuerttemberg 79068
    Germany

    Site Not Available

  • Novartis Investigative Site

    Freiburg im Breisgau 2925177, Baden-Wurttemberg 2953481 79068
    Germany

    Site Not Available

  • Novartis Investigative Site

    Rheinstetten 6558039, Baden-Wurttemberg 2953481 76287
    Germany

    Site Not Available

  • Novartis Investigative Site

    Kulmbach 2882588, Bavaria 2951839 95326
    Germany

    Site Not Available

  • Novartis Investigative Site

    Lauf an der Pegnitz 2880144, Bavaria 2951839 91207
    Germany

    Site Not Available

  • Novartis Investigative Site

    Kulmbach, Bayern 95326
    Germany

    Site Not Available

  • Novartis Investigative Site

    Lauf an der Pegnitz, Bayern 91207
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hamburg 2911298, Hamburg 2911297 22549
    Germany

    Site Not Available

  • Novartis Investigative Site

    Lingen Ems, Lower Saxony 2862926 49809
    Germany

    Site Not Available

  • Novartis Investigative Site

    Kroepelin, Mecklenburg Vorpommern 18236
    Germany

    Site Not Available

  • Novartis Investigative Site

    Kröpelin 2883602, Mecklenburg-Vorpommern 2872567 18236
    Germany

    Site Not Available

  • Novartis Investigative Site

    Krefeld, Nordrhein-Westfalen 47798
    Germany

    Site Not Available

  • Novartis Investigative Site

    Moenchengladbach, Nordrhein-Westfalen 41061
    Germany

    Site Not Available

  • Novartis Investigative Site

    Krefeld 2884509, North Rhine-Westphalia 2861876 47798
    Germany

    Site Not Available

  • Novartis Investigative Site

    Mainz, Rheinland Pfalz 55128
    Germany

    Site Not Available

  • Novartis Investigative Site

    Mainz 2874225, Rhineland-Palatinate 2847618 55128
    Germany

    Site Not Available

  • Novartis Investigative Site

    Leipzig, Sachsen 04207
    Germany

    Site Not Available

  • Novartis Investigative Site

    Lutherstadt Wittenberg, Sachsen-Anhalt 06886
    Germany

    Site Not Available

  • Novartis Investigative Site

    Leipzig 2879139, Saxony 2842566 04207
    Germany

    Site Not Available

  • Novartis Investigative Site

    Wittenberg 7303020, Saxony-Anhalt 2842565 06886
    Germany

    Site Not Available

  • Novartis Investigative Site

    Aachen, 52064
    Germany

    Site Not Available

  • Novartis Investigative Site

    Aachen 3247449, 52064
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ahaus, 48683
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ahaus 2959279, 48683
    Germany

    Site Not Available

  • Novartis Investigative Site

    Annaberg-Buchholz, 09456
    Germany

    Site Not Available

  • Novartis Investigative Site

    Annaberg-Buchholz 2956005, 09456
    Germany

    Site Not Available

  • Novartis Investigative Site

    Augsburg, 86150
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bad Steben, 95138
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bad Steben 2953334, 95138
    Germany

    Site Not Available

  • Novartis Investigative Site

    Baden-Baden, 76530
    Germany

    Site Not Available

  • Novartis Investigative Site

    Baden-Baden 2953504, 76530
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bergen, 18528
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bergen 2950622, 18528
    Germany

    Site Not Available

  • Novartis Investigative Site

    Berlin, 14052
    Germany

    Site Not Available

  • Novartis Investigative Site

    Berlin 2950159, 13595
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bielefeld, 33647
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bielefeld 2949186, 33647
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bochum, 44791
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bochum 2947416, 44791
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bonn, 53105
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bonn 2946447, 53105
    Germany

    Site Not Available

  • Novartis Investigative Site

    Brandenburg 2945358, 14776
    Germany

    Site Not Available

  • Novartis Investigative Site

    Brandenburg An Der Havel, 14776
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bremen, 28219
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bremen 2944388, 28359
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bueckeburg, 31675
    Germany

    Site Not Available

  • Novartis Investigative Site

    Buxtehude, 21614
    Germany

    Site Not Available

  • Novartis Investigative Site

    Buxtehude 2940451, 21614
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bückeburg 2942159, 31675
    Germany

    Site Not Available

  • Novartis Investigative Site

    Chemnitz, 09117
    Germany

    Site Not Available

  • Novartis Investigative Site

    Chemnitz 2940132, 09113
    Germany

    Site Not Available

  • Novartis Investigative Site

    Cologne 2886242, 51065
    Germany

    Site Not Available

  • Novartis Investigative Site

    Delitzsch, 04509
    Germany

    Site Not Available

  • Novartis Investigative Site

    Delitzsch 2938376, 04509
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dessau 2937959, 06847
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dessau Rosslau, 06847
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dessau-Rosslau, 06847
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dorsten, 46282
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dorsten 2935530, 46282
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dortmund, 44137
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dortmund 2935517, 44137
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dresden, 01307
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dresden 2935022, 01309
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dueren, 52349
    Germany

    Site Not Available

  • Novartis Investigative Site

    Duren, 52349
    Germany

    Site Not Available

  • Novartis Investigative Site

    Düren 2934486, 52349
    Germany

    Site Not Available

  • Novartis Investigative Site

    Emsdetten, 48282
    Germany

    Site Not Available

  • Novartis Investigative Site

    Emsdetten 2930449, 48282
    Germany

    Site Not Available

  • Novartis Investigative Site

    Erlangen, 91054
    Germany

    Site Not Available

  • Novartis Investigative Site

    Erlangen 2929567, 91054
    Germany

    Site Not Available

  • Novartis Investigative Site

    Falkenberg, 04895
    Germany

    Site Not Available

  • Novartis Investigative Site

    Falkenberg 2928011, 04895
    Germany

    Site Not Available

  • Novartis Investigative Site

    Falkensee, 14612
    Germany

    Site Not Available

  • Novartis Investigative Site

    Falkensee 2927930, 14612
    Germany

    Site Not Available

  • Novartis Investigative Site

    Freising, 85354
    Germany

    Site Not Available

  • Novartis Investigative Site

    Freising 2925034, 85354
    Germany

    Site Not Available

  • Novartis Investigative Site

    Geilenkirchen, 52511
    Germany

    Site Not Available

  • Novartis Investigative Site

    Geilenkirchen 2921837, 52511
    Germany

    Site Not Available

  • Novartis Investigative Site

    Gelsenkirchen, 45899
    Germany

    Site Not Available

  • Novartis Investigative Site

    Gera, 07548
    Germany

    Site Not Available

  • Novartis Investigative Site

    Gera 2921232, 07548
    Germany

    Site Not Available

  • Novartis Investigative Site

    Gernsbach, 76593
    Germany

    Site Not Available

  • Novartis Investigative Site

    Gernsbach 2920997, 76593
    Germany

    Site Not Available

  • Novartis Investigative Site

    Giessen, 35385
    Germany

    Site Not Available

  • Novartis Investigative Site

    Gladbeck, 45964
    Germany

    Site Not Available

  • Novartis Investigative Site

    Gladbeck 2920236, 45964
    Germany

    Site Not Available

  • Novartis Investigative Site

    Grossenhain, 01558
    Germany

    Site Not Available

  • Novartis Investigative Site

    Großenhain 2916630, 01558
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hamburg, 22143
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hannover, 30159
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hanover 2910831, 30159
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hasfurt, 97437
    Germany

    Site Not Available

  • Novartis Investigative Site

    Haslach im Kinzigtal, 77716
    Germany

    Site Not Available

  • Novartis Investigative Site

    Haslach im Kinzigtal 2909523, 77716
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hofgeismar, 34369
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hofgeismar 2902559, 34369
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ilmenau, 98693
    Germany

    Site Not Available

  • Novartis Investigative Site

    Jena, 07743
    Germany

    Site Not Available

  • Novartis Investigative Site

    Jena 2895044, 07743
    Germany

    Site Not Available

  • Novartis Investigative Site

    Juelich, 52428
    Germany

    Site Not Available

  • Novartis Investigative Site

    Jülich 2894553, 52428
    Germany

    Site Not Available

  • Novartis Investigative Site

    Karlsruhe, 76133
    Germany

    Site Not Available

  • Novartis Investigative Site

    Karlsruhe 2892794, 76133
    Germany

    Site Not Available

  • Novartis Investigative Site

    Kempen, 47906
    Germany

    Site Not Available

  • Novartis Investigative Site

    Kempen 2891643, 47906
    Germany

    Site Not Available

  • Novartis Investigative Site

    Kiel, 24103
    Germany

    Site Not Available

  • Novartis Investigative Site

    Koeln, 50674
    Germany

    Site Not Available

  • Novartis Investigative Site

    Kronach, 96317
    Germany

    Site Not Available

  • Novartis Investigative Site

    Lauf, 91207
    Germany

    Site Not Available

  • Novartis Investigative Site

    Lingen, 49809
    Germany

    Site Not Available

  • Novartis Investigative Site

    Luebeck, 23538
    Germany

    Site Not Available

  • Novartis Investigative Site

    Lübeck 2875601, 23538
    Germany

    Site Not Available

  • Novartis Investigative Site

    Magdeburg, 39120
    Germany

    Site Not Available

  • Novartis Investigative Site

    Magdeburg 2874545, 39104
    Germany

    Site Not Available

  • Novartis Investigative Site

    Marburg, 35043
    Germany

    Site Not Available

  • Novartis Investigative Site

    Marburg 2873759, 35043
    Germany

    Site Not Available

  • Novartis Investigative Site

    Minden, 32429
    Germany

    Site Not Available

  • Novartis Investigative Site

    Minden 2871039, 32429
    Germany

    Site Not Available

  • Novartis Investigative Site

    Monchengladbach, 41061
    Germany

    Site Not Available

  • Novartis Investigative Site

    Muenchen, 81539
    Germany

    Site Not Available

  • Novartis Investigative Site

    Mönchengladbach, 41061
    Germany

    Site Not Available

  • Novartis Investigative Site

    Mönchengladbach 2869894, 41063
    Germany

    Site Not Available

  • Novartis Investigative Site

    Neu Wulmstorf, 21629
    Germany

    Site Not Available

  • Novartis Investigative Site

    Neu Wulmstorf 2863795, 21629
    Germany

    Site Not Available

  • Novartis Investigative Site

    Neuss, 41460
    Germany

    Site Not Available

  • Novartis Investigative Site

    Neuwied, 56564
    Germany

    Site Not Available

  • Novartis Investigative Site

    Nuernberg, 90419
    Germany

    Site Not Available

  • Novartis Investigative Site

    Nuremberg 2861650, 90419
    Germany

    Site Not Available

  • Novartis Investigative Site

    Oberasbach, 90522
    Germany

    Site Not Available

  • Novartis Investigative Site

    Oberasbach 2861402, 90522
    Germany

    Site Not Available

  • Novartis Investigative Site

    Oelde, 59302
    Germany

    Site Not Available

  • Novartis Investigative Site

    Oelde 2857943, 59302
    Germany

    Site Not Available

  • Novartis Investigative Site

    Oelsnitz, 09376
    Germany

    Site Not Available

  • Novartis Investigative Site

    Panketal, 16341
    Germany

    Site Not Available

  • Novartis Investigative Site

    Peitz, 03185
    Germany

    Site Not Available

  • Novartis Investigative Site

    Peitz 2855024, 03185
    Germany

    Site Not Available

  • Novartis Investigative Site

    Potsdam, 14469
    Germany

    Site Not Available

  • Novartis Investigative Site

    Potsdam 2852458, 14469
    Germany

    Site Not Available

  • Novartis Investigative Site

    Remscheid, 42897
    Germany

    Site Not Available

  • Novartis Investigative Site

    Remscheid 2848273, 42897
    Germany

    Site Not Available

  • Novartis Investigative Site

    Rheinstetten Moersch, 76287
    Germany

    Site Not Available

  • Novartis Investigative Site

    Schweinfurt, 97421
    Germany

    Site Not Available

  • Novartis Investigative Site

    Selters, 56242
    Germany

    Site Not Available

  • Novartis Investigative Site

    Selters 2833139, 56242
    Germany

    Site Not Available

  • Novartis Investigative Site

    Simmern, 55469
    Germany

    Site Not Available

  • Novartis Investigative Site

    Simmern 2832013, 55469
    Germany

    Site Not Available

  • Novartis Investigative Site

    Soest, 59494
    Germany

    Site Not Available

  • Novartis Investigative Site

    Soest 2831708, 59494
    Germany

    Site Not Available

  • Novartis Investigative Site

    Stolberg, 52222
    Germany

    Site Not Available

  • Novartis Investigative Site

    Stolberg 2826595, 52222
    Germany

    Site Not Available

  • Novartis Investigative Site

    Unna, 59423
    Germany

    Site Not Available

  • Novartis Investigative Site

    Unna 2820087, 59423
    Germany

    Site Not Available

  • Novartis Investigative Site

    Vechta, 49377
    Germany

    Site Not Available

  • Novartis Investigative Site

    Wittlich, 54316
    Germany

    Site Not Available

  • Novartis Investigative Site

    Wittlich 2807240, 54316
    Germany

    Site Not Available

  • Novartis Investigative Site

    Wuppertal, 42103
    Germany

    Site Not Available

  • Novartis Investigative Site

    Wuppertal 2805753, 42103
    Germany

    Site Not Available

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