Long-term real-world tracking of secukinumab treatment for moderate to severe hidradenitis suppurativa in Italy

Long Term Observational, Prospective, Multicenter Study to Collect in a Real-world populatIon Data on the Treatment Pattern of Secukinumab in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (HS) Within the Italian Population (ANIMA - Italy)

This project will see how secukinumab works and is used in adults with moderate to severe hidradenitis suppurativa in Italy.

Quick facts

• Study type: Observational
• Enrollment: 250 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Novartis (Industry-sponsored)
• Drugs / interventions: secukinumab
• Locations: 8 sites (Ancona, AN and 7 other locations)
• Trial ID: NCT07543419 on ClinicalTrials.gov

What this trial studies

This is a multicenter, prospective observational program collecting long-term real-world data on adults with moderate to severe hidradenitis suppurativa who start secukinumab as part of routine care. Investigators will record clinical characteristics, treatment patterns, patient responses, safety signals, and link consenting patients to administrative data to measure healthcare resource use and economic impact. Eligible participants are adults (≥18) with moderate or severe HS who initiate secukinumab within 30 days of enrollment and have not previously received the drug via the Managed Access Program. Data are collected at participating Novartis investigative sites in Italy and follow local standard clinical practice without introducing experimental procedures.

Who should consider this trial

Good fit: Adults aged 18 or older with moderate to severe hidradenitis suppurativa who are about to start secukinumab within 30 days and can give written informed consent.

Not a fit: Patients with mild HS, those who started secukinumab before enrollment or who cannot provide consent or access participating sites are unlikely to benefit from this program.

Why it matters

Potential benefit: If successful, the information could help clinicians choose and manage secukinumab treatment and inform healthcare planning for patients with moderate to severe HS in Italy.

How similar studies have performed: Small clinical and real-world reports of secukinumab in HS have shown promising responses, but larger and longer-term evidence remains limited compared with established biologics.

Eligibility criteria

Inclusion Criteria:

Study participants eligible for inclusion in this study must meet all the following criteria:

1\. Male and Female patients who provide written informed consent and privacy form (ICF\&PF) to participate in the study.

2\. 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.

4\. 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:

5\. Patients who provide written ICF\&PF to allow the use of secondary (administrative) data for the purposes of this study.

6\. 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).

Exclusion Criteria:

Study participants meeting any of the following criteria are not eligible for inclusion in this study:

7\. 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:

9\. 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.

Where this trial is running

Ancona, AN and 7 other locations

• Novartis Investigative Site — Ancona, An, Italy (Recruiting)
• Novartis Investigative Site — Brescia, Bs, Italy (Recruiting)
• Novartis Investigative Site — Florence, Fi, Italy (Recruiting)
• Novartis Investigative Site — Lecce, Le, Italy (Recruiting)
• Novartis Investigative Site — Messina, Me, Italy (Recruiting)
• Novartis Investigative Site — Rozzano, Mi, Italy (Recruiting)
• Novartis Investigative Site — San Donato Milanese, Mi, Italy (Recruiting)
• Novartis Investigative Site — Trento, Tn, Italy (Recruiting)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions Hidradenitis Suppurativa; HS; secukinumab; NIS; LHUs