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Study on Long-term Effects of Secukinumab in Patients with Moderate to Severe Hidradenitis Suppurativa

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called secukinumab on a skin condition known as hidradenitis suppurativa. Hidradenitis suppurativa is a chronic skin disease that causes small, painful lumps to form under the skin, often in areas where skin rubs together. The study aims to understand how effective and safe secukinumab is for people with moderate to severe forms of this condition. Secukinumab is given as a solution for injection under the skin.

The purpose of the study is to compare the long-term effects of continuous versus interrupted treatment with secukinumab. Participants who have already responded well to secukinumab in previous studies will continue to receive the medication, while others will receive a placebo. The study will monitor how long it takes for symptoms to return in those who stop the medication compared to those who continue it. The study will also keep track of any side effects, changes in laboratory test results, and vital signs to ensure the treatment is safe.

Participants in the study will receive injections of secukinumab or a placebo over a period of time, and their progress will be monitored regularly. The study is designed to last until 2026, allowing researchers to gather comprehensive data on the long-term effects of the treatment. This information will help determine the best way to manage hidradenitis suppurativa with secukinumab in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after providing written informed consent. This is a formal agreement to participate in the study after understanding all relevant information.

  2. Step 2

    Eligibility confirmation

    Eligibility is confirmed for those who completed 52 weeks of treatment in previous studies and received secukinumab during that time.

  3. Step 3

    Treatment phase

    Participants receive secukinumab or a placebo. Secukinumab is administered as a subcutaneous injection.

    The dosage is 300 mg, given either every four weeks (q4w) or every two weeks (q2w), depending on the assigned group.

  4. Step 4

    Monitoring and assessment

    Regular assessments are conducted to monitor the response to treatment. This includes checking for any increase in abscesses or nodules.

    The primary goal is to observe the time to loss of response up to Week 104. Loss of response is defined as a significant increase in abscess and/or nodule count.

  5. Step 5

    Safety evaluations

    Safety is evaluated through monitoring adverse events, laboratory test results, and vital signs throughout the study.

  6. Step 6

    Completion of study

    The study is estimated to conclude by August 7, 2026. Participants will have completed the study by this date, following all assessments and evaluations.

Who can join the trial?

5 criteria

  • You must provide a signed document that shows you agree to participate in the study. This is called written informed consent.
  • You need to have completed the entire 52-week treatment period in the previous related studies, known as the core studies.
  • You must have received a specific treatment called secukinumab during the second part of the treatment in the core studies.
  • Both men and women can participate in this study.
  • The study includes people who might be considered vulnerable, meaning they may need extra care or protection.

Who cannot join the trial?

10 criteria

  • Patients who have not responded to treatment in previous studies.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are not willing to use effective birth control methods during the study.
  • Patients who have a history of allergic reactions to the study medication.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have received certain medications that might interfere with the study.
  • Patients who have had a recent infection or illness that could affect the study results.
  • Patients who have a history of cancer, except for certain types of skin cancer.
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Investigated drugs

Secukinumab: This medication is used in the trial to treat individuals with moderate to severe hidradenitis suppurativa, a chronic skin condition. Secukinumab is administered through an injection under the skin. The study aims to evaluate its long-term effectiveness, safety, and how well patients tolerate it. Participants who responded well to the treatment in earlier stages of the study continue to receive secukinumab to see if it maintains its benefits over time.

What is already known about the treatment

Secukinumab – Secukinumab is administered as an injection under the skin, typically every two to four weeks. It is currently being studied for its long-term effectiveness and safety in treating moderate to severe hidradenitis suppurativa, a chronic skin condition. The medication works by targeting and blocking a specific protein in the immune system called interleukin-17A, which plays a role in inflammation. Secukinumab is classified as a biologic medication, specifically a monoclonal antibody, and is used to reduce inflammation and improve symptoms in various inflammatory conditions.

Investigated diseases

Hidradenitis suppurativa – Hidradenitis suppurativa is a chronic skin condition characterized by the development of painful lumps under the skin, typically in areas where skin rubs together, such as the armpits, groin, and under the breasts. These lumps can become inflamed and may rupture, leading to the formation of tunnels under the skin and scarring. The disease often starts after puberty and can persist for many years, with periods of flare-ups and remission. The exact cause is not fully understood, but it is believed to involve hair follicles becoming blocked and inflamed. The condition can vary in severity, with some individuals experiencing mild symptoms and others having more severe and widespread involvement.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508956-20-00Protocol codeCAIN457M2301E1Estimated enrolment546 patientsSponsorNovartis Pharma AG

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