Study on the Effectiveness and Safety of Remibrutinib for Adults with Moderate to Severe Hidradenitis Suppurativa

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
ICMR (International Center for Medical Research) Madrid Spain
Hospital Universitario Y Politecnico La Fe Valencia Spain
Centrul Medical Euromed S.R.L. Bucharest Romania
Universitaet Leipzig Leipzig Germany
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France
Katholieke Universiteit te Leuven Leuven Belgium
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Centre hospitalier universitaire de Liege Liege Belgium
Klinikum Dortmund gGmbH Dortmund Germany
Hospital Universitario 12 De Octubre Madrid Spain
Muehlenkreiskliniken AöR Minden Germany
Fakultni Nemocnice Bulovka Prague Czechia
Complexo Hospitalario Universitario De Pontevedra Pontevedra Spain
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis La Rochelle France
Hospital Universitario Virgen De Las Nieves Granada Spain
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Hospital General De Granollers Granollers Spain
Derma-B Kft. Debrecen Hungary
Klinika Ambroziak Sp. z o.o. Warsaw Poland
Karlovarska krajska nemocnice a.s. Karlovy Vary Czechia
Tagast 41 Nice France
Hms GmbH Merzig Germany
Havelklinik GmbH & Co. KG Berlin Germany
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
University Of Debrecen Debrecen Hungary
Spitalul Clinic Colentina Bucuresti Bucharest Romania
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Semmelweis University Budapest Hungary
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Andreas Syngros Hospital Of Venereal And Dermatological Diseases Athens Greece
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila Bucharest Romania
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Of Pecs Pecs Hungary
Centre Hospitalier Lyon Sud Pierre Benite France
Servei De Salut De Les Illes Balears Palma Spain
University Of Szeged Szeged Hungary
Dermafit Centrum s.r.o. Plzen Czechia
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Courlancy Sante Reims France
Royalderm Agnieszka Nawrocka Warsaw Poland
Cssowjdap Uexszcaekdxoif Sdpyipmda Woluwe-Saint-Lambert Belgium
Uhoyxevngc Myemkwy Clnxfm Hjgxqxlizvxzjlxzr Hamburg Germany
Udolxfbxgxismgcyzjdkt Ebntp Aqe Essen Germany
Ovjfnczyjfkkka Ljcn Gmsn Linz Austria
Twejdjrxdjv umi Sxpbjivmkqb Biwgfzyo Gshf Bad Bentheim Germany
Dnzxnpojflr shlzmw Prague Czechia
Dn Tqfcml Dftylpqvufsndskzh Sdwaby Timisoara Romania
Bevxfreetto Vvgoyijah Obvcpyazmpdm Kecskemet Hungary
Fqcucpwo ndvsfvzoz Mgyas a Hvlnppb Prague Czechia
Udkkutkclyfdattfiwcvv Dympzscbexu Ale Duesseldorf Germany
Pqeyborzz Ilpxjlqq Mxverovu Maptpwjzqsuf Syvfa Wmqqbqoxvltf I Alpuodqpidyok Warsaw Poland
Giwgyh Uvdqjemhwx Fkurpzunj Frankfurt Germany
Unccswyocbwsnqshckymo Wmbwmkuak Ali Wuerzburg Germany
Hfdbslha Dr Lh Sbqwz Cogh I Slwf Prc Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
05.06.2025
Belgium Belgium
Not recruiting
05.06.2025
Czechia Czechia
Not recruiting
05.06.2025
France France
Not recruiting
05.06.2025
Germany Germany
Not recruiting
05.06.2025
Greece Greece
Not recruiting
05.06.2025
Hungary Hungary
Not recruiting
05.06.2025
Poland Poland
Not recruiting
05.06.2025
Romania Romania
Not recruiting
05.06.2025
Spain Spain
Not recruiting
05.06.2025

Trial locations

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.

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 ID:
2024-513266-19-00
Protocol code:
CLOU064J12302
Trial Phase:
Therapeutic confirmatory (Phase III)

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