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 HS Within the Italian Population

NCT07543419 | Recruiting

• 1 other identifier: CAIN457MIT03
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 8

Brief Summary

The aim of this study is to generate real-world evidence to fill knowledge gaps regarding the response to secukinumab in patients with moderate to severe HS, its treatment patterns, the clinical characteristics of patients on secukinumab, healthcare resource utilization and the economic impact of HS in Italy.

Conditions

Hidradenitis Suppurativa

Keywords

Hidradenitis Suppurativa; HS; secukinumab; NIS; LHUs

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving 55% reduction in IHS4 (IHS4-55) during the observational period.

  Proportion of patients achieving International Hidradenitis Suppurativa Severity Score System 55% reduction(IHS4-55) during the observational period. The IHS4 is an exclusively physician-based, clinical scoring system for dynamic assessment of HS severity. Determining IHS4 requires counting nodules, abscesses and draining tunnels/sinus tracts, which is easy to calculate. The IHS4 score is calculated as the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (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

  Baseline,6 months and 1 and 1,5 years after initiation of secukinumab

Secondary Outcomes (34)

• Proportion of patients achieving 55% reduction in IHS4 (IHS4-55) stratified by dosing

  6 months, 1 and 1.5 years after initiation of secukinumab treatment

• Proportion of patients achieving 75% reduction in IHS4 (IHS4-75) and 100% reduction in IHS4 (IHS4-100)

  6 months, 1 and 1.5 years after initiation of secukinumab treatment

• Proportion of patients achieving 50% reduction in HiSCR (HiSCR-50) and 75% reduction in HiSCR (HiSCR-75)

  6 months, 1 and 1.5 years after initiation of secukinumab treatment

• Number, type, and localization of HS lesions

  baseline, 6 months, 1 and 1.5 years after initiation of secukinumab treatment

• Change of total abscess and inflammatory nodule count

  6 months, 1 and 1.5 years after initiation of secukinumab treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include male and female adult patients (aged ≥ 18 years) with a diagnosis of moderate or severe HS and initiating treatment with secukinumab according to clinical practice

You may qualify if:

• \. Male and Female patients who provide written informed consent and privacy form (ICF\&PF) to participate in the study.
• \. Aged ≥ 18 years at ICF\&PF signature. 3. Patients with moderate or severe HS (IHS4 and/or Hurley staging system, as assessed by the investigators) at index date.
• \. The start of secukinumab is within 30 days after the ICF\&PF signature (enrolment), as per local standard clinical practice. Patients were not treated with secukinumab before enrolment within the Managed Access Program (MAP). The initiation of secukinumab is based on dermatologist's own practice, regardless of study participation.
• For HRU and economic burden only:
• \. Patients who provide written ICF\&PF to allow the use of secondary (administrative) data for the purposes of this study.
• \. Patients with more than 12 months of residence inside the area of competence of the LHU (applicable only to study sites associated with the 6 LHUs).

You may not qualify if:

• \. Participation in an ongoing clinical trial. 8. Any medical or psychological condition that may prevent study participation, based on practitioners' decision-making.
• For HRU and economic burden only:
• \. Patients will be excluded if the unique identifier does not allow them to be identified in the LHU administrative databases related to the site where they were enrolled.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (8)

Novartis Investigative Site

Ancona, AN, 60126, Italy

RECRUITING

Novartis Investigative Site

Brescia, BS, 25123, Italy

RECRUITING

Novartis Investigative Site

Florence, FI, 50122, Italy

RECRUITING

Novartis Investigative Site

Lecce, LE, 73100, Italy

RECRUITING

Novartis Investigative Site

Messina, ME, 98125, Italy

RECRUITING

Novartis Investigative Site

Rozzano, MI, 20089, Italy

RECRUITING

Novartis Investigative Site

San Donato Milanese, MI, 20097, Italy

RECRUITING

Novartis Investigative Site

Trento, TN, 38100, Italy

RECRUITING

MeSH Terms

Conditions

Hidradenitis Suppurativa

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

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

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

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: April 21, 2026
• Study Start: December 17, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (8)