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Italian study tracks Real-World use of secukinumab for painful skin condition

NCT ID NCT07543419

Knowledge-focused Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 21, 2026 · Updated 2 times

Summary

This study follows 250 Italian adults with moderate to severe hidradenitis suppurativa (a chronic skin disease causing painful lumps) who are starting secukinumab. Researchers will track how well the drug reduces skin lesions over time and how it affects healthcare use and costs. The goal is to learn how the treatment works in real life, not just in controlled trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will include male and female adult patients (aged ≥ 18 years) with a diagnosis of moderate or severe HS and initiating treatment with secukinumab according to clinical practice

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hidradenitis suppurativa

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hidradenitis suppurativa

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    16 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Novartis Investigative Site

    RECRUITING

    Ancona, AN, 60020, Italy

  • Novartis Investigative Site

    RECRUITING

    Bari, BA, 70124, Italy

  • Novartis Investigative Site

    RECRUITING

    Brescia, BS, 25123, Italy

  • Novartis Investigative Site

    RECRUITING

    Cona, FE, 44124, Italy

  • Novartis Investigative Site

    RECRUITING

    Florence, FI, 50122, Italy

  • Novartis Investigative Site

    RECRUITING

    Genova, GE, 16132, Italy

  • Novartis Investigative Site

    RECRUITING

    Lecce, LE, 73100, Italy

  • Novartis Investigative Site

    RECRUITING

    Messina, ME, 98125, Italy

  • Novartis Investigative Site

    RECRUITING

    Milan, MI, 20122, Italy

  • Novartis Investigative Site

    RECRUITING

    Rozzano, MI, 20089, Italy

  • Novartis Investigative Site

    RECRUITING

    San Donato Milanese, MI, 20097, Italy

  • Novartis Investigative Site

    RECRUITING

    Palermo, PA, 90127, Italy

  • Novartis Investigative Site

    RECRUITING

    Perugia, PG, 06129, Italy

  • Novartis Investigative Site

    RECRUITING

    Trento, TN, 38100, Italy

  • Novartis Investigative Site

    RECRUITING

    Udine, UD, 33100, Italy

  • Novartis Investigative Site

    RECRUITING

    Naples, 80131, Italy

More trials for these conditions

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