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

Recruiting now

Conditions studied: Hidradenitis Suppurativa

In brief

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.

Key facts

Study ID

NCT07543419

Run by

Novartis Pharmaceuticals

People needed

250

Starts

2025-12-17

Expected to finish

2028-09-30

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

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

Where it is running

• Novartis Investigative Site — Ancona, AN, Italy (enrolling)
• Novartis Investigative Site — Bari, BA, Italy (enrolling)
• Novartis Investigative Site — Brescia, BS, Italy (enrolling)
• Novartis Investigative Site — Cona, FE, Italy (enrolling)
• Novartis Investigative Site — Florence, FI, Italy (enrolling)
• Novartis Investigative Site — Genova, GE, Italy (enrolling)
• Novartis Investigative Site — Lecce, LE, Italy (enrolling)
• Novartis Investigative Site — Messina, ME, Italy (enrolling)
• Novartis Investigative Site — Milan, MI, Italy (enrolling)
• Novartis Investigative Site — Rozzano, MI, Italy (enrolling)
• Novartis Investigative Site — San Donato Milanese, MI, Italy (enrolling)
• Novartis Investigative Site — Palermo, PA, Italy (enrolling)
• Novartis Investigative Site — Perugia, PG, Italy (enrolling)
• Novartis Investigative Site — Trento, TN, Italy (enrolling)
• Novartis Investigative Site — Udine, UD, Italy (enrolling)
• Novartis Investigative Site — Naples, Italy (enrolling)

Full record on ClinicalTrials.gov

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