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.

NCT05921994 | Active Not Recruiting

• 1 other identifier: CAIN457MDE01
• Study Type: observational
• Target: 434
• Locations: 1 country
• Sites: 80

Brief 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.

Conditions

Hidradenitis Suppurativa

Keywords

Hidradenitis suppurativa; HS; secukinumab; Germany; NIS

Outcome Measures

Primary Outcomes (12)

• Proportion of patients receiving up-titration

  Proportion of patients receiving up-titration (q4w-to-q2w)

  Up to 24 months

• Proportion of patients receiving down-titration

  Proportion of patients receiving down-titration (q2w-to-q4w)

  Up to 24 months

• Time to up-titration and down-titration

  Time to up-titration and down-titration

  Up to 2 years

• Duration of q4w treatment with secukinumab after dose reduction

  Duration of q4w treatment with secukinumab after dose reduction

  Up to 2 years

• 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

• 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

• Number and type of surgical interventions

  Number and type of surgical interventions * minor and major surgical excision; * inpatient, outpatient

  Up to 2 years

• 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

• 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

• 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

• Mean reduction of Abscesses and inflammatory nodules (AN) count

  Mean reduction of Abscesses and inflammatory nodules (AN) count

  Up to 24 months

• 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

Study Arms (1)

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.

Other: secukinumab

Interventions

secukinumab OTHER

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

secukinumab

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Patients who provide written informed consent to participate in the study
• Male and female patients with ≥18 years of age
• Diagnosis of clinically unequivocal moderate to severe HS
• Patients for whom a therapy with secukinumab is medically indicated
• Documented decision for treatment with marketed secukinumab regardless of this noninterventional study
• Treatment with secukinumab according to the latest version of SmPC
• Initial treatment with marketed secukinumab planned for up to 1 week before the baseline visit

You may not qualify if:

• 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
• Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the study participation
• Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with secukinumab
• Previous exposure to IL-17 inhibitors
• For biologic-naïve patients, previous exposure to another biologic drug, such as anti-TNF-α inhibitors

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (80)

Novartis Investigative Site

Freiburg im Breisgau, Baden-Wurttemberg, 79068, Germany

Location

Novartis Investigative Site

Rheinstetten, Baden-Wurttemberg, 76287, Germany

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Novartis Investigative Site

Haßfurt, Bavaria, 97437, Germany

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Novartis Investigative Site

Kulmbach, Bavaria, 95326, Germany

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Novartis Investigative Site

Lauf an der Pegnitz, Bavaria, 91207, Germany

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Novartis Investigative Site

Nuremberg, Bavaria, 90402, Germany

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Novartis Investigative Site

Panketal, Brandenburg, 16341, Germany

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Novartis Investigative Site

Hamburg, Free and Hanseatic City of Hamburg, 22549, Germany

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Novartis Investigative Site

Lingen Ems, Lower Saxony, 49809, Germany

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Novartis Investigative Site

Bergen auf Rügen, Mecklenburg-Vorpommern, 18528, Germany

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Novartis Investigative Site

Kröpelin, Mecklenburg-Vorpommern, 18236, Germany

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Novartis Investigative Site

Krefeld, North Rhine-Westphalia, 47798, Germany

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Novartis Investigative Site

Mainz, Rhineland-Palatinate, 55128, Germany

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Novartis Investigative Site

Dresden, Saxony, 01307, Germany

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Novartis Investigative Site

Leipzig, Saxony, 04207, Germany

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Novartis Investigative Site

Leipzig, Saxony, 04289, Germany

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Novartis Investigative Site

Wittenberg, Saxony-Anhalt, 06886, Germany

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Novartis Investigative Site

Aachen, 52064, Germany

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Novartis Investigative Site

Ahaus, 48683, Germany

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Novartis Investigative Site

Annaberg-Buchholz, 09456, Germany

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Novartis Investigative Site

Bad Steben, 95138, Germany

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Novartis Investigative Site

Baden-Baden, 76530, Germany

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Novartis Investigative Site

Berlin, 12159, Germany

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Novartis Investigative Site

Berlin, 13595, Germany

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Novartis Investigative Site

Bielefeld, 33647, Germany

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Novartis Investigative Site

Bochum, 44791, Germany

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Novartis Investigative Site

Bonn, 53105, Germany

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Novartis Investigative Site

Brandenburg, 14776, Germany

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Novartis Investigative Site

Bremen, 28359, Germany

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Novartis Investigative Site

Buxtehude, 21614, Germany

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Novartis Investigative Site

Bückeburg, 31675, Germany

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Novartis Investigative Site

Chemnitz, 09113, Germany

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Novartis Investigative Site

Chemnitz, 09117, Germany

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Novartis Investigative Site

Cologne, 51065, Germany

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Novartis Investigative Site

Delitzsch, 04509, Germany

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Novartis Investigative Site

Dessau, 06847, Germany

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Novartis Investigative Site

Dorsten, 46282, Germany

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Novartis Investigative Site

Dortmund, 44137, Germany

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Novartis Investigative Site

Dresden, 01309, Germany

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Novartis Investigative Site

Düren, 52349, Germany

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Novartis Investigative Site

Emsdetten, 48282, Germany

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Novartis Investigative Site

Erlangen, 91054, Germany

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Novartis Investigative Site

Falkenberg, 04895, Germany

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Novartis Investigative Site

Falkensee, 14612, Germany

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Novartis Investigative Site

Freising, 85354, Germany

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Novartis Investigative Site

Geilenkirchen, 52511, Germany

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Novartis Investigative Site

Gera, 07548, Germany

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Novartis Investigative Site

Gernsbach, 76593, Germany

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Novartis Investigative Site

Gladbeck, 45964, Germany

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Novartis Investigative Site

Großenhain, 01558, Germany

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Novartis Investigative Site

Hamburg, 20246, Germany

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Novartis Investigative Site

Hamburg, 22143, Germany

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Novartis Investigative Site

Hanover, 30159, Germany

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Novartis Investigative Site

Haslach im Kinzigtal, 77716, Germany

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Novartis Investigative Site

Hofgeismar, 34369, Germany

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Novartis Investigative Site

Jena, 07743, Germany

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Novartis Investigative Site

Jülich, 52428, Germany

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Novartis Investigative Site

Karlsruhe, 76133, Germany

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Novartis Investigative Site

Kempen, 47906, Germany

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Novartis Investigative Site

Lübeck, 23538, Germany

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Novartis Investigative Site

Magdeburg, 39104, Germany

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Novartis Investigative Site

Magdeburg, 39120, Germany

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Novartis Investigative Site

Mainz, 55116, Germany

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Novartis Investigative Site

Marburg, 35043, Germany

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Novartis Investigative Site

Minden, 32429, Germany

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Novartis Investigative Site

Mönchengladbach, 41063, Germany

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Novartis Investigative Site

Neu Wulmstorf, 21629, Germany

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Novartis Investigative Site

Nuremberg, 90419, Germany

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Novartis Investigative Site

Oberasbach, 90522, Germany

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Novartis Investigative Site

Oelde, 59302, Germany

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Novartis Investigative Site

Peitz, 03185, Germany

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Novartis Investigative Site

Potsdam, 14469, Germany

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Novartis Investigative Site

Remscheid, 42897, Germany

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Novartis Investigative Site

Selters, 56242, Germany

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Novartis Investigative Site

Simmern, 55469, Germany

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Novartis Investigative Site

Soest, 59494, Germany

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Novartis Investigative Site

Stolberg, 52222, Germany

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Novartis Investigative Site

Unna, 59423, Germany

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Novartis Investigative Site

Wittlich, 54316, Germany

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Novartis Investigative Site

Wuppertal, 42103, Germany

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MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 28, 2023
• Study Start: August 10, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (80)