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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Novartis Investigative Site
  Ancona, An, Italy Recruiting
• Novartis Investigative Site
  Bari, Ba, Italy Recruiting
• Novartis Investigative Site
  Brescia, Bs, Italy Recruiting
• Novartis Investigative Site
  Cona, Fe, Italy Recruiting
• Novartis Investigative Site
  Florence, Fi, Italy Recruiting
• Novartis Investigative Site
  Genova, Ge, Italy Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Secukinumab outcomes in Canadians with hidradenitis suppurativa

  It will see how well secukinumab works and how safe it is for adults in Canada with moderate-to-severe hidradenitis suppurativa who were newly prescribed it in routine care.

  Recruiting at 15 sites Novartis · Calgary, Alberta and 14 other locations · NCT07282015

• Post-marketing surveillance of Cosentyx (secukinumab) for hidradenitis suppurativa, pediatric plaque psoriasis, and juvenile idiopathic arthritis in Korea

  This study will see how Cosentyx (secukinumab) works and is tolerated in people in Korea with moderate-to-severe hidradenitis suppurativa, pediatric plaque psoriasis, or juvenile idiopathic arthritis who are being treated in routine care.

  Recruiting Novartis · Seoul, Seoul · NCT07243782

• BTK inhibitor remibrutinib in hidradenitis suppurativa shows how it works in adults

  This phase 1 trial tests whether remibrutinib can safely affect HS in adults with moderate to severe disease.

  Recruiting at 2 sites Phase 1 Novartis · San Diego, California and 1 other locations · NCT07855276

• Olatorepatide vs placebo for adults with moderate-to-severe hidradenitis suppurativa who are overweight

  This study tests whether olatorepatide can help people with hidradenitis suppurativa who are overweight or obese.

  Recruiting Phase 2 Regeneron Pharmaceuticals · The Bronx, New York · NCT07830329

• Secukinumab retention in adults with plaque psoriasis and MASLD in Spain

  This study tests how long people with plaque psoriasis and MASLD stay on secukinumab in real-world Spain, using EMR data from several hospitals.

  Recruiting at 9 sites Novartis · Badalona, Barcelona and 8 other locations · NCT07683065

• Remibrutinib extension study for adults with moderate to severe hidradenitis suppurativa

  This extension study tests whether continuing remibrutinib is safe and helps skin symptoms in adults who completed prior HS trials.

  Recruiting at 61 sites Phase 3 Novartis · Birmingham, Alabama and 60 other locations · NCT07665437

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.