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Study on the Effects 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 a skin condition called Hidradenitis Suppurativa, which is characterized by painful lumps under the skin, often in areas like the armpits and groin. The study will evaluate the effectiveness and safety of a medication called Remibrutinib, which is taken as a film-coated tablet. Remibrutinib works by inhibiting a specific enzyme in the body, potentially reducing inflammation and the formation of these painful lumps.

Participants in the study will be randomly assigned to receive either Remibrutinib or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for 68 weeks, during which the participants' response to the treatment will be closely monitored. The main goal is to see if Remibrutinib can reduce the number of abscesses and inflammatory nodules by at least 50% after 16 weeks of treatment.

In addition to Remibrutinib, the study will also involve the use of other treatments like Triamcinolone Acetonide and Salicylic Acid, which are known for their anti-inflammatory properties, as well as systemic antibiotics like Clindamycin Hydrochloride. These treatments will be used to support the main study medication and help manage the symptoms of Hidradenitis Suppurativa. The study aims to provide valuable information on the potential benefits of Remibrutinib for individuals suffering from this challenging 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.

Step 1
Joining the study
Upon joining the study, you will be required to provide a signed informed consent form. This confirms your understanding and agreement to participate in the trial.
You must be at least 18 years old and have been diagnosed with hidradenitis suppurativa for at least six months. This condition involves painful lumps under the skin.
Step 2
Baseline assessment
A baseline assessment will be conducted to evaluate the severity of your condition. This includes counting the number of abscesses and inflammatory nodules, which are types of skin lesions.
The assessment will also determine if the lesions affect at least two different areas of your body.
Step 3
Treatment phase
You will be randomly assigned to receive either the study medication remibrutinib or a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drug.
The medication is taken orally in the form of a film-coated tablet. The exact dosage and frequency will be provided by the study team.
The treatment period lasts for 68 weeks, during which you will take the medication as instructed.
Step 4
Regular check-ups
Throughout the study, regular check-ups will be scheduled to monitor your condition and any changes in your symptoms.
These check-ups will include assessments similar to the baseline assessment to track progress and any side effects.
Step 5
Evaluation of results
The primary goal is to achieve a HiSCR50 at week 16, which means at least a 50% reduction in the number of abscesses and nodules without an increase in other symptoms.
Secondary goals include further reductions in symptoms and monitoring any adverse effects during the study.
Step 6
End of study
At the end of the study period, a final assessment will be conducted to evaluate the overall effectiveness and safety of the treatment.
You will be informed of the results and any further steps if 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) based on their medical history and a physical examination for at least 6 months before the start of the study.
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 the left and right underarms.

Who cannot join the trial?

10 criteria

Patients with any other skin conditions that might interfere with the study results cannot participate.
Patients who have had a recent infection or are currently experiencing an infection are not eligible.
Patients who have a history of cancer, except for certain types of skin cancer, cannot join the study.
Patients who are pregnant or breastfeeding are not allowed to participate.
Patients who have used certain medications that might affect the study results within a specific time frame before the study starts are not eligible.
Patients with a history of drug or alcohol abuse within the past year cannot participate.
Patients with certain heart conditions or uncontrolled high blood pressure are not eligible.
Patients who have participated in another clinical trial within a certain period before this study cannot join.
Patients with a known allergy to the study medication or similar drugs are not allowed to participate.
Patients who have had major surgery within a specific time frame before the study starts are not eligible.

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Verified sites

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Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
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Madrid, Spain
Katholisches Klinikum Bochum gGmbH
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Bochum, Germany
Studienzentrum Dr. Beate Schwarz
Responsive
Langenau, Germany

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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 a placebo, which is a substance with no active medication. The goal is to see if remibrutinib can significantly improve the condition after 16 weeks of treatment.

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 presence 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.