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Study on the Effectiveness and Safety of Remibrutinib for Adults 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 remibrutinib 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 the skin rubs together. The study will compare the effectiveness of remibrutinib to a placebo, which is a substance with no active medication, to see if remibrutinib can help reduce the symptoms of this condition.

The purpose of the study is to assess how well remibrutinib works in reducing the number of painful lumps and abscesses in patients with moderate to severe hidradenitis suppurativa. Participants in the study will receive either remibrutinib or a placebo over a period of 68 weeks. The study will also involve the use of other medications, such as clindamycin hydrochloride, a type of antibiotic, and triamcinolone acetonide, a medication used to reduce inflammation. These medications will be administered to help manage the symptoms of the disease.

Throughout the study, participants will be monitored to evaluate the safety and tolerability of remibrutinib. The study aims to determine if remibrutinib can achieve a significant reduction in the symptoms of hidradenitis suppurativa, such as a decrease in the number of abscesses and inflammatory nodules. The results will help to understand if remibrutinib is a viable treatment option for individuals suffering from this challenging skin condition.

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

    Upon joining the study, you will be randomly assigned to receive either the study medication, remibrutinib, or a placebo. A placebo is a substance that looks like the study medication but does not contain any active ingredients.

    The study is designed to be double-blind, meaning neither you nor the study team will know which treatment you are receiving. This helps ensure the results are not influenced by expectations.

  2. Step 2

    Treatment period

    The treatment period lasts for 68 weeks. During this time, you will take the assigned medication orally in the form of a film-coated tablet.

    You will be required to take the medication as directed by the study team. The specific dosage and frequency will be provided to you at the start of the study.

  3. Step 3

    Regular assessments

    Throughout the study, you will have regular assessments to monitor your condition and the effects of the treatment. These assessments will include physical examinations and possibly other tests as determined by the study team.

    The main goal is to evaluate the effectiveness of the treatment in reducing the number of abscesses and inflammatory nodules associated with hidradenitis suppurativa.

  4. Step 4

    Primary evaluation

    At week 16, a primary evaluation will be conducted to determine if there has been at least a 50% reduction in the number of abscesses and inflammatory nodules without an increase in abscesses or draining tunnels.

    This evaluation is crucial in assessing the initial effectiveness of the treatment.

  5. Step 5

    Secondary evaluations

    Additional evaluations will occur throughout the study to assess further improvements, such as a 75% or 90% reduction in symptoms, and to monitor any potential side effects.

    These evaluations help provide a comprehensive understanding of the treatment's impact on your condition.

  6. Step 6

    Completion of the study

    Upon completion of the 68-week treatment period, a final assessment will be conducted to evaluate the overall effectiveness and safety of the treatment.

    The study team will discuss the results with you and provide guidance on any further steps or treatments that may be necessary.

Who can join the trial?

5 criteria

  • Signed informed consent must be obtained before participating in the study. This means you agree to join the study after understanding all the details.
  • Participants must be 18 years of age or older at the time of signing the informed consent forms.
  • Participants must have a diagnosis of Hidradenitis Suppurativa (HS) for at least 6 months before the start of the study. This diagnosis is based on your medical history and a physical examination.
  • Participants must have moderate to severe HS at the start of the study, which means:
    • Having at least 5 abscesses (swollen areas filled with pus) and/or inflammatory nodules (small lumps under the skin).
    • The inflammatory lesions must affect at least 2 different areas of the body, such as both underarms.

Who cannot join the trial?

10 criteria

  • Patients with any other skin condition that might interfere with the study results.
  • Patients who have had a recent infection that required treatment with antibiotics.
  • Patients who have a history of cancer, except for certain types of skin cancer that have been treated and are not active.
  • Patients who have a history of heart problems, such as heart attack or heart failure.
  • Patients who have a history of liver disease or liver problems.
  • Patients who have a history of kidney disease or kidney problems.
  • Patients who are currently using other medications that might interfere with the study treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial within the last 30 days.
  • Patients who have a known allergy to the study medication or its ingredients.
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Investigated drugs

Remibrutinib is a medication being studied for its potential to help people with a skin condition called hidradenitis suppurativa, which causes painful lumps under the skin. This medication works by targeting specific pathways in the body that are involved in inflammation. By doing so, it aims to reduce the symptoms and improve the quality of life for those affected by this condition. The trial is designed to see how effective and safe remibrutinib is over a period of time, compared to not taking the medication. Participants in the trial will receive remibrutinib to see if it helps reduce the severity of their symptoms.

What is already known about the treatment

Remibrutinib – Remibrutinib is administered orally in the form of tablets and is currently being studied in clinical trials for its effectiveness in treating moderate to severe hidradenitis suppurativa, a chronic skin condition. The medication is in the Phase 3 stage of clinical trials, which means it is being tested for safety and effectiveness in a larger group of patients. Remibrutinib works by targeting specific proteins in the body that are involved in the inflammatory process, helping to reduce inflammation and symptoms associated with the condition. It is classified as a Bruton’s tyrosine kinase (BTK) inhibitor, a type of drug that interferes with the signaling pathways that lead to inflammation.

Investigated diseases

Hidradenitis Suppurativa – Hidradenitis Suppurativa is a chronic skin condition characterized by the formation 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 abscesses and tunnels under the skin. Over time, the condition can lead to scarring and the development of sinus tracts, which are channels that connect the lumps under the skin. The disease often starts after puberty and can persist for many years, with periods of flare-ups and remission. The exact cause of Hidradenitis Suppurativa is not fully understood, but it is believed to involve a combination of genetic, hormonal, and environmental factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513266-19-00Protocol codeCLOU064J12302Estimated enrolment532 patientsSponsorNovartis Pharma AG

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