Last Update: Apr 21, 2026
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)
ClinicalTrials.gov Identifier:
Novartis Reference Number:CAIN457MIT03
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

Hidradenitis Suppurativa
Recruiting
250
Dec 17, 2025
Sep 30, 2028
All
18 Years - 100 Years (Adult, Older Adult)

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.

Novartis Investigative Site

Recruiting

Ancona,AN,60126,Italy

Novartis Investigative Site

Recruiting

Brescia,BS,25123,Italy

Novartis Investigative Site

Recruiting

Florence,FI,50122,Italy

Novartis Investigative Site

Recruiting

Lecce,LE,73100,Italy

Novartis Investigative Site

Recruiting

Messina,ME,98125,Italy

Novartis Investigative Site

Recruiting

Rozzano,MI,20089,Italy

Novartis Investigative Site

Recruiting

San Donato Milanese,MI,20097,Italy

Novartis Investigative Site

Recruiting

Trento,TN,38100,Italy

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