Clinical trial • Phase III • Dermatology

REMIBRUTINIB for Chronic spontaneous urticaria

Phase III trial of REMIBRUTINIB for Chronic spontaneous urticaria.

Overview

Trial Therapeutic Area
Dermatology
Trial Disease
Chronic spontaneous urticaria
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
18-07-2024
First CTIS Authorization Date
21-08-2024

Trial design

Randomised, open-label, placebo to remibrutinib (lou064) 25 mg film-coated tablet (matching placebo) (placebo comparator arm as stated: 'placebo to remibrutinib (lou064) 25 mg film-coated tablet').-controlled Phase III trial across 56 sites in Denmark, Italy, Spain and others.

Randomised
Yes
Open Label
Yes
Comparator
Placebo to remibrutinib (LOU064) 25 mg film-coated tablet (matching placebo) (placebo comparator arm as stated: 'Placebo to remibrutinib (LOU064) 25 mg film-coated tablet').
Target Sample Size
496

Eligibility

Recruits 496 Participants are adults (≥18). Written informed consent must be obtained before any assessment is performed. Vulnerable populations not selected..

Vulnerable Population
Participants are adults (≥18). Written informed consent must be obtained before any assessment is performed. Vulnerable populations not selected.

Inclusion criteria

  • {"criterion_text":"- Written informed consent must be obtained before any assessment is performed.\n- Male and female, adult participants ≥18 years of age.\n- Participants who successfully completed the preceding core studies CLOU064A2301, CLOU064A2302, CLOU064A1301 or CLOU064A2305 according to the respective protocols.\n- Willing and able to adhere to the study protocol and visit schedule."}

Exclusion criteria

  • {"criterion_text":"- Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, NYHA (New York heart association) Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension within 12 months prior to enrollment), neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant\n- Significant bleeding risk or coagulation disorders.\n- History of gastrointestinal bleeding, e.g., in association with use of nonsteroidal anti-inflammatory drugs (NSAID), that was clinically relevant\n- Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel) is prohibited\n- Requirement for anticoagulant medication (for example, warfarin or Novel Oral Anti-Coagulants (NOACs)).\n- History or current hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or Aspartate Aminotransferase (AST)/ Alanine Aminotransferase (ALT) levels of more than 1.5 x upper limit of normal (ULN) or International Normalized Ratio (INR) of more than 1.5 at the last 2 available visits of the preceding core study"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Time to first composite event (i.e., relapse (UAS7≥16), study treatment discontinuation due to lack of efficacy or intake of strongly confounding prohibited medication) during the randomized withdrawal period.","definition_or_measurement_approach":"Time-to-event analysis measuring time to first of the composite events during the randomized withdrawal period; relapse is defined as UAS7 ≥ 16; includes discontinuation due to lack of efficacy or intake of strongly confounding prohibited medication up to Week 24 compared to placebo."}

Secondary endpoints

  • {"endpoint_text":"- Safety endpoints will include but not be limited to: occurrence of treatment-emergent (serious and non-serious) adverse events during the extension study","definition_or_measurement_approach":"Recording and reporting of treatment-emergent adverse events (serious and non-serious) that occur during the extension study period."}

Recruitment

Planned Sample Size
496
Recruitment Window Months
51
Consent Approach
Written informed consent must be obtained before any assessment is performed. Consent is provided by adult participants (≥18 years). Subject information and informed consent forms (L1_ICF - Main ICF - Adult) are available in multiple languages used at participating countries (English, Danish, Italian, Spanish, German, Hungarian, Slovak, French, Bulgarian, Polish, Czech and others as provided per country-specific documents). Follow-up/pregnancy and additional optional consent documents are available for specific assessments where applicable.

Geography

Total Number Of Sites
56
Total Number Of Participants
200

Denmark

Earliest CTIS Part Ii Submission Date
13-08-2024
Latest Decision Or Authorization Date
30-04-2025
Processing Time Days
260
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Gentofte Hospital
Department Name
9152: Afdeling for Allergi, Hud- og Kønssygdomme
Contact Person Name
Lone Skov
Contact Person Email
lone.skov.02@regionh.dk
Site Name
Region Hovedstaden
Department Name
9151: Dermato-Venerologisk Afdeling og Videncenter for Sårheling
Contact Person Name
Simon Francis Thomsen

Italy

Earliest CTIS Part Ii Submission Date
13-08-2024
Latest Decision Or Authorization Date
05-05-2025
Processing Time Days
265
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
9451:S. C. Allergologia e Immunologia
Contact Person Name
Jan Walter Schroeder
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
9453:S. C. Clinica di Dermatologia
Contact Person Name
Oriana Simonetti

Spain

Earliest CTIS Part Ii Submission Date
13-08-2024
Latest Decision Or Authorization Date
05-05-2025
Processing Time Days
265
Number Of Sites
9
Number Of Participants
25

Sites

Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
9757; Dermatología
Contact Person Name
Mercedes Rodriguez Serna
Contact Person Email
merroser@gmail.com
Site Name
Hospital Universitario De La Princesa
Department Name
9762; Dermatología
Contact Person Name
Diego Fernandez de Argila Duran
Contact Person Email
dargilad@hotmail.com
Site Name
Hospital Arnau De Vilanova De Valencia
Department Name
9758; Dermatología
Contact Person Name
Francisco Javier Miquel Miquel
Contact Person Email
fjmiquel0406@gmail.com
Site Name
Hospital General Universitario Dr. Balmis
Department Name
9753; Dermatología
Contact Person Name
Juan Francisco Silvestre Salvador
Contact Person Email
silvestre_jfr@gva.es
Site Name
Hospital Del Mar
Department Name
9751; Dermatología
Contact Person Name
Ana Maria Gimenez Arnau
Contact Person Email
anamariagimenezarnau@gmail.com
Site Name
El Hospital Universitario De Gran Canaria Dr. Negrin
Department Name
9755; Dermatología
Contact Person Name
Irene Castano Gonzalez
Contact Person Email
irenecastano@hotmail.com
Site Name
Clinica Universidad De Navarra
Department Name
9754; Alergología
Contact Person Name
Marta Ferrer Puga
Contact Person Email
mferrerp@unav.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
9763; Dermatología
Contact Person Name
Francisco Javier Ortiz de Frutos
Contact Person Email
javierortiz@aedv.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
9752; Alergología
Contact Person Name
Moises Labrador Horrillo
Contact Person Email
mlabrador@vhebron.net

Germany

Earliest CTIS Part Ii Submission Date
13-08-2024
Latest Decision Or Authorization Date
02-05-2025
Processing Time Days
262
Number Of Sites
13
Number Of Participants
52

Sites

Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
9313; Klinik und Poliklinik für Dermatologie
Contact Person Name
Andrea Bauer
Contact Person Email
Andrea.bauer@ukdd.de
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
9303; Klinik und Poliklinik für Dermatologie und Allergologie
Contact Person Name
Knut Brockow
Contact Person Email
Knut.brockow@tum.de
Site Name
Dermatologische Praxis Dr. med. Abdou Zarzour
Department Name
9315;
Contact Person Name
Abdou Zarzour
Contact Person Email
zarzour@gmx.de
Site Name
Fachklinik Bad Bentheim
Department Name
9302; Dermatologische Studienambulanz
Contact Person Name
Athanasios Tsianakas
Contact Person Email
tsianakas@fk-bentheim.de
Site Name
Universitaet Leipzig
Department Name
9310; Klinik für Dermatologie, Venerologie und Allergologie
Contact Person Name
Jan Christoph Simon
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
9317; Institut für Entzündungsmedizin
Contact Person Name
Thomasz Hawro
Contact Person Email
Thomasz.hawro@uksh.de
Site Name
Martin-Luther-Universitaet Halle-Wittenberg
Department Name
9311; Zentrum für klinische Studien Dermatologie
Contact Person Name
Burkhardt Kreft
Contact Person Email
Burkhardt.kreft@uk-halle.de
Site Name
Derma Zentrum Osnabruck Nord
Department Name
9308;
Contact Person Name
Ansgar Weyergraf
Contact Person Email
Aweyergraf_dzosn@web.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
9309; Institut für Allergologie IFA
Contact Person Name
Martin Metz
Contact Person Email
Martin.metz@charite.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
9301; Clinical Research Center der Hautklinik und Poliklinik
Contact Person Name
Petra Staubach-Renz
Site Name
Medizinische Hochschule Hannover
Department Name
9320; Klinik für Dermatologie, Allergologie und Venerologie
Contact Person Name
Bettina Wedi
Contact Person Email
Wedi.bettina@mh-hannover.de
Site Name
Universitaetsklinikum Giessen und Marburg GmbH
Department Name
9304; Klinik für Dermatologie und Allergologie
Contact Person Name
Wolfgang Pfützner
Contact Person Email
wpfuetzn@med.uni-marburg.de
Site Name
Universitaetsmedizin Goettingen
Department Name
9306; Klinik für Dermatologie, Venerologie und Allergologie
Contact Person Name
Undine Lippert

Hungary

Earliest CTIS Part Ii Submission Date
13-08-2024
Latest Decision Or Authorization Date
06-05-2025
Processing Time Days
266
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
University Of Debrecen
Department Name
9401; Borgyogyaszati Klinika
Contact Person Name
Andrea Szegedi
Contact Person Email
aszegedi@med.unideb.hu
Site Name
Derma-B Kft.
Department Name
9402;
Contact Person Name
Emese Heredi
Contact Person Email
emeseheredi@gmail.com

Slovakia

Earliest CTIS Part Ii Submission Date
13-08-2024
Latest Decision Or Authorization Date
30-04-2025
Processing Time Days
260
Number Of Sites
6
Number Of Participants
17

Sites

Site Name
AlergoImuno centrum s.r.o.
Department Name
9704;Ambulancia klinickej imunológie a alergológie
Contact Person Name
Ivan Hlinka
Contact Person Email
hlinka@centrum.sk
Site Name
Danimed spol. s r.o.
Department Name
9708;Ambulancia klinickej imunológie a alergológie
Contact Person Name
Daniela Hasičová
Contact Person Email
daniela.hasicova@gmail.com
Site Name
Univerzitna nemocnica L. Pasteura Kosice
Department Name
9701;Klinika dermatovenerológie
Contact Person Name
Tomáš Kampe
Contact Person Email
tomaskampe@gmail.com
Site Name
Fakultna Nemocnica S Poliklinikou Nove Zamky
Department Name
9706;Dermatovenerologická klinika
Contact Person Name
Erika Baloghová
Contact Person Email
erika.senohradska@gmail.com
Site Name
Alergo H2b s.r.o.
Department Name
9707;Ambulancia klinickej imunológie a alergológie
Contact Person Name
Svetlana Hadvabová
Contact Person Email
hadvabova@gmail.com
Site Name
Sanare spol. s r.o.
Department Name
9702;Dermatovenerologická ambulancia
Contact Person Name
Hana Zelenková
Contact Person Email
zelenkova@vl.sk

Bulgaria

Earliest CTIS Part Ii Submission Date
13-08-2024
Latest Decision Or Authorization Date
16-01-2026
Processing Time Days
521
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Alexandrovska University Hospital
Department Name
9051: Clinic of Clinical Allergology
Contact Person Name
Maria Staevska - Kotasheva
Contact Person Email
marikotasheva@gmail.com
Site Name
Medical Center Excelsior OOD
Department Name
9052
Contact Person Name
Todor Popov
Contact Person Email
ted.popov@gmail.com
Site Name
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Department Name
9053: Department of Clinical Allergology at address
Contact Person Name
Vanya Tsvetkova-Vicheva
Contact Person Email
vmtsvetkova@abv.bg

Poland

Earliest CTIS Part Ii Submission Date
13-08-2024
Latest Decision Or Authorization Date
02-02-2026
Processing Time Days
538
Number Of Sites
4
Number Of Participants
19

Sites

Site Name
Alergologia Plus Sp. z o.o.
Department Name
9503
Contact Person Name
Ewa Springer
Contact Person Email
alergologiaplus@wp.pl
Site Name
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Department Name
9501;Klinika Dermatologii
Contact Person Name
Irena Walecka – Herniczek
Contact Person Email
irena.walecka@cskmswia.gov.pl
Site Name
Specjalistyczne Gabinety Lekarskie DERMED Anna Kaszuba
Department Name
9504
Contact Person Name
Andrzej Kaszuba
Contact Person Email
andrzej.kaszuba@dermed.com.pl
Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Department Name
9505;Klinika Alergologii i Chorób Wewnętrznych
Contact Person Name
Marcin Moniuszko
Contact Person Email
marcin.moniuszko@umb.edu.pl

Czechia

Earliest CTIS Part Ii Submission Date
13-08-2024
Latest Decision Or Authorization Date
03-02-2026
Processing Time Days
539
Number Of Sites
4
Number Of Participants
14

Sites

Site Name
Fakultni Nemocnice U Sv Anny V Brne
Department Name
9104; Dermatoveneroglogicka klinika
Contact Person Name
Miroslav Necas
Contact Person Email
info@fnusa.cz
Site Name
University Hospital Olomouc
Department Name
9101; Klinika corob koznich a pohlavnich
Contact Person Name
Viktor Palla
Contact Person Email
kozni@fnol.cz
Site Name
Fakultni Nemocnice Plzen
Department Name
9102; Dermatologicka klinika
Contact Person Name
Karel Pizinger
Contact Person Email
fnplzen@fnplzen.cz
Site Name
Fakultni Nemocnice Motol A Homolka
Department Name
9103; Dermatovenerologicke oddeleni
Contact Person Name
Alena Machovcova
Contact Person Email
podatelna@fnmotol.cz

France

Earliest CTIS Part Ii Submission Date
13-08-2024
Latest Decision Or Authorization Date
29-04-2025
Processing Time Days
259
Number Of Sites
11
Number Of Participants
51

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
9211; Dermatologie
Contact Person Name
Angele SORIA
Contact Person Email
angele.soria@aphp.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
9209; Dermatologie
Contact Person Name
Aurelie DU THANH
Contact Person Email
a-du_thanh@chu-montpellier.fr
Site Name
Courlancy Sante
Department Name
9203; Dermatologie
Contact Person Name
Ziad REGUIAI
Contact Person Email
dr-reguiai@orange.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
9210; Dermatologie
Contact Person Name
Laurent Miséry
Contact Person Email
Laurent.misery@chu-brest.fr
Site Name
Unite De Recherche Clinique HIA Begin
Department Name
9212; Dermatologie
Contact Person Name
Aude Roussel
Contact Person Email
Aude.roussel@intradef.gouv.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
9206; Dermatologie
Contact Person Name
Julien SENESCHAL
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
9205; Dermatologie
Contact Person Name
Florence TETART
Contact Person Email
florence.tetart@chu-rouen.fr
Site Name
Hopital Prive D Antony
Department Name
9204; Maladies auto-immunes et de dermatologie
Contact Person Name
Andre BECHEREL
Contact Person Email
pa.becherel@ramsaygds.fr
Site Name
Hospices Civils De Lyon
Department Name
9201; Allergologie et d'immunologie clinique
Contact Person Name
Frederic BERARD
Contact Person Email
frederic.berard@chu-lyon.fr
Site Name
Tagast 41
Department Name
9202, Dermatologie
Contact Person Name
Abdallah KHEMIS
Contact Person Email
dermato@khemis06.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
9208; Dermatologie
Contact Person Name
Ludovic MARTIN
Contact Person Email
lumartin@chu-angers.fr

Sponsor

Primary sponsor

Full Name
Novartis Pharma AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
Parexel International (IRL) Limited
Responsibilities
code 12
Name
Syneos Health Inc.
Responsibilities
code 1
Name
IQVIA Limited
Responsibilities
code 3
Name
Icon Clinical Research Limited
Responsibilities
code 1; code 10
Name
Eresearchtechnology Inc.
Responsibilities
code 13
Name
Medidata Solutions Inc.
Responsibilities
code 7

Third parties

  • {"country":"Slovakia","full_name":"Movianto Slovensko s.r.o.","duties_or_roles":"Storage and distribution of locally purchased medication (rescue medication), storage of drug sample","organisation_type":"Pharmaceutical company"}
  • {"country":"Denmark","full_name":"Specific Pharma A/S","duties_or_roles":"Pass-through warehouse (drug distribution, drug return, destruction and relabeling)","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Phardis S.r.l.","duties_or_roles":"Local equipment storage","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Kayentis","duties_or_roles":"Trial Feedback Questionnaire (TFQ); code 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Italy","full_name":"Opis S.r.l.","duties_or_roles":"TMF archive Activation sites activities","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eurofins Viracor Biopharma Services Inc.","duties_or_roles":"Chronic Urticaria (CU) Panel (CU index, TPO and TG auto-Antibodies)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"code 12","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Komtur Polska Sp. z o.o.","duties_or_roles":"Local purchase of medicinal products (IMP & non-IMP)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"code 1","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"code 3","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Eco-Abc Sp. z o. o.","duties_or_roles":"Destruction of the investigational medicinal products","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"code 13","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"code 1; code 10","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Poland","full_name":"Statmed Sp. z o.o.","duties_or_roles":"Compensation for patients travel to the clinical site","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"code 4","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
LOU064
Active Substance
REMIBRUTINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
prodAuthStatus: 1
Investigational Product Name
Placebo to remibrutinib (LOU064) 25 mg film-coated tablet
Modality
Other
Starting Dose
25 mg (as stated in placebo product name)

Related trials

Other published trials that may interest you.