Study of remibrutinib for long-term treatment of adult patients with chronic spontaneous urticaria who completed previous remibrutinib studies

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What is this study about?

This study focuses on patients with Chronic Spontaneous Urticaria, a condition that causes recurring hives and itching without a known trigger. The study will evaluate a medication called remibrutinib (also known as LOU064), which is taken as a film-coated tablet by mouth. Some participants will receive the actual medication, while others will receive a placebo.

The purpose of this research is to assess how well remibrutinib works over an extended period in patients who have already participated in previous studies of this medication. During the study, patients who showed improvement in their symptoms will either continue taking remibrutinib or switch to placebo. The researchers will monitor how long it takes for symptoms to return, if they do.

Throughout the study, participants may also receive other common treatments for their condition, including antihistamines (medications that reduce allergic symptoms) and corticosteroids (medications that reduce inflammation). The study will track any side effects that occur during the treatment period. The total duration of treatment may last up to 160 weeks, depending on the participant’s response to the medication.

1 Initial medication phase

You will receive remibrutinib in the form of film-coated tablets for oral use

The treatment is intended for adults (18 years and older) with chronic spontaneous urticaria (a condition causing recurring itchy hives)

You need to take the medication as prescribed and attend all scheduled medical visits

2 Assessment period

Your response to the treatment will be monitored using the UAS7 score (a measure of hive severity)

The medical team will evaluate if your score remains below 16 points, which indicates good disease control

3 Randomized withdrawal phase

If your condition is well-controlled, you will be randomly assigned to continue either remibrutinib or receive a placebo (inactive tablet)

This phase lasts up to 24 weeks

Your symptoms will be closely monitored during this period

4 Monitoring for events

The medical team will track any return of symptoms (relapse)

They will note if you need to stop treatment due to lack of effectiveness

Any use of other restricted medications will be documented

5 Safety monitoring

Throughout the study, any side effects or health changes will be recorded

Regular health assessments will be conducted during scheduled visits

The study continues until April 2027

Who Can Join the Study?

  • You must provide written consent before participating in any study activities
  • You must be an adult aged 18 or older
  • You must have completed one of these previous studies successfully:
    • CLOU064A2301
    • CLOU064A2302
    • CLOU064A1301
    • CLOU064A2305
  • You must be willing and able to:
    • Follow all study procedures
    • Attend all scheduled study visits
  • Both men and women can participate in this study

Who Cannot Join the Study?

  • Age below 18 years or above 75 years
  • Pregnant or breastfeeding women
  • History of severe allergic reactions to similar medications
  • Current participation in other clinical trials
  • Presence of other skin conditions that could interfere with urticaria (hives) assessment
  • Uncontrolled or severe medical conditions that could affect study participation
  • Use of prohibited medications within specified timeframe before study start
  • UAS7 score (weekly urticaria activity score) of 16 or higher at Week 52 of previous core study
  • Previous discontinuation from the core study due to lack of efficacy
  • Known hypersensitivity to remibrutinib (study medication) or its components
  • Significant liver or kidney dysfunction
  • Active or chronic infections
  • History of malignancy within the past 5 years
  • Mental conditions that could interfere with study compliance
  • Substance abuse or dependence

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
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Alergologia Plus Sp. z o.o. Poznan Poland
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Specjalistyczna Przychodnia Lekarska Alergo Med Sp. z o.o. Poznan Poland
Derma-B Kft. Debrecen Hungary
Fakultna Nemocnica S Poliklinikou Nove Zamky Nove Zamky Slovakia
Tagast 41 Nice France
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Fakultni Nemocnice Plzen Plzen Czechia
University Of Debrecen Debrecen Hungary
Medical Center Excelsior OOD Sofia Bulgaria
Univerzitna nemocnica L. Pasteura Kosice Kosice Slovakia
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Centre Hospitalier Universitaire De Montpellier Montpellier France
Universita’ Politecnica Delle Marche Ancona Italy
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Justus-Liebig-Universitaet Giessen Giessen Germany
Hopital Prive D Antony Antony France
Unite De Recherche Clinique HIA Begin Saint-Mande France
University Hospital Olomouc Olomouc Czechia
Gentofte Hospital Hellerup Denmark
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Multi-profile Hospital for Active Treatment Heart and Brain EAD Pleven Bulgaria
Danimed spol. s r.o. Levice Slovakia
Courlancy Sante Reims France
Dermatologische Praxis Dr. med. Abdou Zarzour Halle (Saale) Germany
Specjalistyczne Gabinety Lekarskie DERMED Anna Kaszuba Lodz Poland
Derma Zentrum Osnabruck Nord Bramsche Germany
Maezkehdhaggtqjdqnfnkenwdo Hkjcmjjbcfhbonie Halle (Saale) Germany
Halnolbb Utizmjhksovht Dj Lm Parztjwu Madrid Spain
Awzsujpmgak cpmkqtn sygtpf Kezmarok Slovakia
Avnjro Hvr sjhdwe Komarno Slovakia
Fpwibmll nfimqmxne Mxvtc a Hmvryte Prague Czechia
Hnvrom Hbesblax Herlev Denmark
Pdsurpwar Ikhkdfer Mnehsjgb Miuuryxgcfds Sigvj Wyqyicemqeer I Axwctrlerftzv Warsaw Poland
Cqndxh Hrqjylaextu Rdmhvdcg Dcdtyzujgeamgv Angers France
Tiyvumohepn ujg Siefvpvpaay Bnzsozcj Gdmv Bad Bentheim Germany
Hvwjrkks Vdbs dqmqilrm Barcelona Spain

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
24.01.2023
Czechia Czechia
Not recruiting
24.01.2023
Denmark Denmark
Not recruiting
24.01.2023
France France
Not recruiting
24.01.2023
Germany Germany
Not recruiting
24.01.2023
Hungary Hungary
Not recruiting
24.01.2023
Italy Italy
Not recruiting
24.01.2023
Poland Poland
Not recruiting
24.01.2023
Slovakia Slovakia
Not recruiting
24.01.2023
Spain Spain
Not recruiting
24.01.2023

Trial locations

Investigated drugs:

Remibrutinib is a medication being studied for treating chronic spontaneous urticaria (hives). It works by blocking specific proteins in the body that are involved in allergic reactions and inflammation. This medication aims to help control symptoms in patients who experience frequent outbreaks of hives with no known trigger.

A Placebo is included in this study as a control substance. It looks identical to the active medication but contains no active ingredients. It is used to help determine how effective the real medication is by comparing results between patients who receive the active drug and those who receive the placebo.

Investigated diseases:

Chronic Spontaneous Urticaria – A skin condition characterized by the sudden appearance of itchy wheals (hives), angioedema (swelling), or both that recur for 6 weeks or longer. The wheals are temporary and typically resolve within 24 hours, but new ones may appear daily. This condition occurs without any specific external trigger, unlike other forms of urticaria. The itchy welts can appear anywhere on the body, vary in size, and may change shape as the reaction progresses. The condition can significantly affect daily activities and quality of life through persistent itching and discomfort.

Trial ID:
2024-510818-33-00
Protocol code:
CLOU064A2303B
Trial Phase:
Therapeutic confirmatory (Phase III)

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