Study on Remibrutinib for Adults with Chronic Inducible Urticaria Uncontrolled by H1-Antihistamines

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What is this study about?

This clinical trial is focused on studying a condition known as Chronic Inducible Urticaria (CINDU), which includes types like symptomatic dermographism, cold urticaria, and cholinergic urticaria. These are conditions where the skin reacts with hives or welts due to specific triggers such as scratching, cold temperatures, or physical activity. The study is testing a new treatment called remibrutinib (LOU064), which is a low molecular weight compound that works by inhibiting a specific enzyme in the body. This treatment is being compared to a placebo to see how effective it is in helping people with CINDU who have not had success with standard treatments like H1-antihistamines, which are medications that block the effects of histamine, a substance in the body that causes allergy symptoms.

The purpose of the study is to determine if remibrutinib can help more people achieve a complete response, meaning their symptoms are fully controlled, compared to those taking a placebo. Participants in the study will take the medication orally, in the form of a film-coated tablet, over a period of 52 weeks. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo, to ensure unbiased results. There is also an open-label extension, which means that after the initial study period, all participants may have the opportunity to receive the actual medication.

Throughout the study, participants will be monitored for any changes in their symptoms and any side effects they may experience. The study aims to provide valuable information on the safety, effectiveness, and tolerability of remibrutinib for people with CINDU. This research could potentially lead to a new treatment option for those who struggle with this challenging condition.

1 randomization

Upon joining the study, participants are randomly assigned to receive either the active medication, remibrutinib, or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

2 medication administration

Participants take the assigned medication orally. The active medication, remibrutinib, is administered in the form of a 25 mg film-coated tablet. The dosage is taken twice daily (b.i.d), which means once in the morning and once in the evening.

3 initial assessment

At Week 2, participants undergo assessments to evaluate their response to the treatment. This includes measuring changes in symptoms such as itch and hives using specific tests designed for each subtype of Chronic Inducible Urticaria (CINDU).

4 mid-study evaluation

At Week 12, a comprehensive evaluation is conducted to assess the efficacy of the treatment. The primary goal is to determine the proportion of participants who achieve a complete response, meaning significant improvement or resolution of symptoms.

5 ongoing monitoring

Throughout the 52-week study period, participants continue to take the medication and attend regular follow-up visits. These visits are crucial for monitoring safety and any potential side effects.

6 open-label extension

After the initial 52-week period, participants may enter an open-label extension phase. In this phase, all participants receive the active medication, remibrutinib, regardless of their initial group assignment.

7 final assessment

At the end of the study, a final assessment is conducted to evaluate the long-term effects and safety of the treatment. This includes a detailed analysis of symptom changes and any adverse events experienced during the trial.

Who Can Join the Study?

  • Participants must be male or female and at least 18 years old at the time of signing the consent form.
  • Participants must have a confirmed diagnosis of Chronic Inducible Urticaria (CINDU), which includes conditions like symptomatic dermographism, cold urticaria, or cholinergic urticaria for at least 4 months. This means they should have medical records or other proof of the condition.
  • The condition must not be well controlled with H1-AH, which are medications typically used to treat allergies, at the approved doses.
  • Participants must show a specific response to a provocation test for each type of urticaria at the start of the study:
    • For Symptomatic Dermographism: A Total Fric Score of 3 or more using a special test called FricTest® 4.0 and a score of 5 or more for itchiness after the test.
    • For Cold Urticaria: A Critical Threshold Temperature of 15°C or higher using a test called TempTest® 4.0 and a score of 5 or more for itchiness after the test.
    • For Cholinergic Urticaria: A doctor’s assessment of the severity of hives with a score of 2 or more using a test called Pulse-controlled ergometry test and a score of 5 or more for itchiness after the test.

Who Cannot Join the Study?

  • Participants with any other skin condition that might interfere with the study results.
  • Individuals who have had a severe allergic reaction to similar medications in the past.
  • People currently taking medications that could affect the study outcomes.
  • Participants with a history of certain heart conditions.
  • Individuals with uncontrolled high blood pressure.
  • People with a history of certain types of cancer.
  • Participants who are pregnant or breastfeeding.
  • Individuals with a history of drug or alcohol abuse.
  • People with certain infections that are not well controlled.
  • Participants who have been part of another clinical trial recently.

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
Centre Hospitalier Universitaire Rouen Rouen France
Hopital Tenon Paris France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Unidade Local De Saude De Gaia/Espinho E.P.E. Vila Nova De Gaia Portugal
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj Cluj Napoca Romania
Fakultna Nemocnica Trnava Trnava Slovakia
Hospital Universitario Basurto Bilbao Spain
Hospital Universitario Virgen De Las Nieves Granada Spain
Derma-B Kft. Debrecen Hungary
Hospital Universitario Rey Juan Carlos Mostoles Spain
Elbe Kliniken Stade-Buxtehude gGmbH Buxtehude Germany
Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy Bydgoszcz Poland
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie Rzeszow Poland
University Of Debrecen Debrecen Hungary
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Universita’ Politecnica Delle Marche Ancona Italy
Centre Hospitalier Universitaire De Nantes Nantes France
BeneDerma s.r.o. Dubravka Slovakia
Allergo-Derm Bakos Kft. Szolnok Hungary
Hopital Saint Eloi Montpellier France
Hopital Huriez Lille France
University Hospital Consorziale Policlinico Bari Italy
Miejski Szpital Zespolony W Olsztynie Olsztyn Poland
Courlancy Sante Reims France
ROYALDERM Agnieszka Nawrocka Warsaw Poland
SCMS – Profilaxis SRL Timisoara Romania
Cdyubpc Mnfbrrp Dn Drlunoiwfd Sz Tspmenznd Aawyqvohn Nvtykl Srfnbg Brasov Romania
Df Kmwcztffk Gljlxvqtc Groningen The Netherlands
Ifzchoslbyvzuxtp Jb svvgzw Zilina Slovakia
Awcrskehtne cxpeyjs suzozb Kezmarok Slovakia
Uixirggcazrxxmmvdkmju Mkxjylkl Axj Munster Germany
Hjuhpkox Vlir duksiwag Barcelona Spain
Ctawah Hpzyxvyfjn E Uwnnclaxsxszg Dd Cqtszwg Ewnsgz Coimbra Portugal

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

Trial status

Country Status Recruitment Start
France France
Not recruiting
30.09.2024
Germany Germany
Not recruiting
30.09.2024
Hungary Hungary
Not recruiting
30.09.2024
Italy Italy
Not recruiting
30.09.2024
Poland Poland
Not recruiting
30.09.2024
Portugal Portugal
Not recruiting
30.09.2024
Romania Romania
Not recruiting
30.09.2024
Slovakia Slovakia
Not recruiting
30.09.2024
Spain Spain
Not recruiting
30.09.2024
The Netherlands The Netherlands
Not recruiting
30.09.2024

Trial locations

Investigated drugs:

Remibrutinib (LOU064) is a medication being studied for its effectiveness, safety, and tolerability in treating Chronic Inducible Urticaria (CINDU) in adults. This condition includes symptoms like dermographism, cold urticaria, and cholinergic urticaria, which are types of skin reactions. The trial aims to see if remibrutinib can help achieve a complete response in patients who have not been adequately controlled by H1-antihistamines.

Chronic Inducible Urticaria (CINDU) – This is a condition where hives or welts appear on the skin in response to specific triggers. It includes subtypes such as symptomatic dermographism, cold urticaria, and cholinergic urticaria. In symptomatic dermographism, the skin reacts to physical pressure or scratching. Cold urticaria is triggered by exposure to cold temperatures, leading to itchy welts. Cholinergic urticaria occurs due to an increase in body temperature, often from exercise or hot showers, causing small, itchy bumps. The symptoms can vary in intensity and duration, often appearing shortly after exposure to the trigger.

Trial ID:
2023-505739-12-01
Protocol code:
CLOU064M12301
Trial Phase:
Therapeutic confirmatory (Phase III)

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