NCT07543419 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
| NCT ID | NCT07543419 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Hidradenitis Suppurativa |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-12-17 |
| Primary Completion | 2028-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2025-12-17 with a primary completion date of 2028-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT07543419 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Hidradenitis Suppurativa. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07543419 currently recruiting?
Yes, NCT07543419 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT07543419 trial being conducted?
This trial is being conducted at Ancona, Italy, Brescia, Italy, Cona, Italy, Florence, Italy and 7 additional locations.
Who is sponsoring the NCT07543419 clinical trial?
NCT07543419 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 250 participants.