Study on the Effects of Remibrutinib for Adults with Moderate to Severe Hidradenitis Suppurativa

3 1 1

What is this study about?

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.

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.

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.

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.

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.

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.

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 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) 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Universitaetsklinikum Aachen AöR Aachen Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Puerta Del Mar Cadiz Spain
Hospital Del Mar Barcelona Spain
University Hospital Bratislava Bratislava Slovakia
Katholisches Klinikum Bochum gGmbH Bochum Germany
Fakultna Nemocnica Trnava Trnava Slovakia
Hospital Cuf Descobertas S.A. Lisbon Portugal
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
University General Hospital Of Heraklion Heraklion Greece
Hospital Universitario Dr Peset Aleixandre Valencia Spain
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Umbal – Prof. D-R Stoyan Kirkovich AD Stara Zagora Bulgaria
Hospital Universitario De Fuenlabrada Fuenlabrada Spain
Beldio Research GmbH Memmingen Germany
ISA Interdisciplinary Study Association GmbH Berlin Germany
Klinikum Darmstadt GmbH Darmstadt Germany
Elbe Kliniken Stade-Buxtehude gGmbH Buxtehude Germany
Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy Bydgoszcz Poland
Universitaetsklinikum Erlangen AöR Erlangen Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Universita’ Politecnica Delle Marche Ancona Italy
Hospital General Universitario De Valencia Valencia Spain
Eurofins bioskin GmbH Hamburg Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Medikard s.r.o. Presov Slovakia
Azienda USL Toscana Centro Prato Italy
Cliniq s.r.o. Bratislava Slovakia
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Universita Degli Studi Di Brescia Brescia Italy
Universita’ Degli Studi Di Ferrara Ferrara Italy
Region Sjaelland Holbæk Denmark
ASMC – IPSMC – Skin And Venereal Diseases Sofia Bulgaria
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Praxis Dr. med. Abdou Zarzour Halle (Saale) Germany
Dermoklinika Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak Lodz Poland
Hautaerzte Zentrum Hannover Hanover Germany
Mjpgfmb Cggqxj Krhuks Obd Pleven Bulgaria
Pvhm Ttnnn Hjwjjjnn Ubtvaziqosmo Sabadell Spain
Hmulda Hglwesyi Herlev Denmark
Aaegieu Odtdtuuqtki Uajpugollitmf Colevponmnok Dfvrr Sgruxd E Dkpke Srpinvo Dg Tfkous Turin Italy
Urvrczxlcfvikkrsimcia Mjjrrdpn Ack Munster Germany
Uqxkbaixfkspyu Cmrikjo Kjpkcnoaa Gdansk Poland
Fidmucuev Ptxt Lb Ijlsfejisdqyu Bvpdgjoaw Dtl Hnlreiwg Usnlldazxfsrs Ls Pje Madrid Spain
Hozvustr Ujzcqlgdrvifr Howyvpwo Tmpnh y Pkkmgn Iqiifhnl Ccgfvw drotxwrzatflejrql (rfzf Badalona Spain
Colqmf Hsftsravma E Ueaqglemtwhcf Dc Cqibdjk Eepckj Coimbra Portugal

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
03.06.2025
Denmark Denmark
Not recruiting
03.06.2025
Germany Germany
Not recruiting
03.06.2025
Greece Greece
Not recruiting
03.06.2025
Italy Italy
Not recruiting
03.06.2025
Poland Poland
Not recruiting
03.06.2025
Portugal Portugal
Not recruiting
03.06.2025
Slovakia Slovakia
Not recruiting
03.06.2025
Spain Spain
Not recruiting
03.06.2025

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 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.

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.

Trial ID:
2024-513282-39-00
Protocol code:
CLOU064J12301
NCT ID:
NCT06799000
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Evaluation of CIT-013 at two dose levels compared to placebo for treating moderate to severe Hidradenitis Suppurativa

    Recruiting

    2 1
    Germany The Netherlands Poland Spain
  • A study to evaluate the effectiveness and safety of LAD328 in adults with moderate to severe hidradenitis suppurativa

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria France Germany Poland Spain