Clinical trial • Phase III • Immunology

REMIBRUTINIB for Chronic inducible urticaria (CINDU) | Cold urticaria | Cholinergic urticaria | Symptomatic dermographism

Phase III trial of REMIBRUTINIB for Chronic inducible urticaria (CINDU) | Cold urticaria | Cholinergic urticaria | Symptomatic dermographism.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Chronic inducible urticaria (CINDU) | Cold urticaria | Cholinergic urticaria | Symptomatic dermographism
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
30-04-2024
First CTIS Authorization Date
26-08-2024

Trial design

Randomised, placebo to remibrutinib (lou064) xx mg film-coated tablet (placebo arm); remibrutinib (lou064) xx mg twice daily (b.i.d.) as active arm.-controlled Phase III trial in Netherlands, Poland, Italy and others.

Randomised
Yes
Comparator
Placebo to Remibrutinib (LOU064) XX mg film-coated tablet (placebo arm); remibrutinib (LOU064) XX mg twice daily (b.i.d.) as active arm.
Target Sample Size
244
Trial Duration For Participant
364

Eligibility

Recruits 244 No vulnerable populations selected (isVulnerablePopulationSelected=false). Participants must be ≥18 years old; informed consent is obtained via adult ICFs (subject information and informed consent forms available in country/language-specific versions)..

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected=false). Participants must be ≥18 years old; informed consent is obtained via adult ICFs (subject information and informed consent forms available in country/language-specific versions).

Inclusion criteria

  • {"criterion_text":"- Male and female participants ≥18 years of age at the time of signing of the ICFs"}
  • {"criterion_text":"- Confirmed CINDU diagnosis (as per guidelines) for symptomatic dermographism, cold urticaria or cholinergic urticaria for ≥ 4 months (defined as onset of CINDU with supporting documentation (e.g medical record, clinical history, photographs)) and inadequate control with H1-AH at local label approved doses at the time of randomization"}
  • {"criterion_text":"- The following response to the provocation test for each subtype is required at the randomization visit : •\tSymptomatic Dermographism: A Total Fric Score of ≥3 using the FricTest® 4.0 and a numerical rating scale score of ≥5 for itch after the provocation test. •\tCold Urticaria: A Critical Threshold Temperature of ≥15°C using the TempTest® 4.0 and a numerical rating scale score of ≥5 for itch after the provocation test. •\tCholinergic Urticaria: A physician global assessment of severity of hives ≥ 2 using the Pulse-controlled ergometry test and a numerical rating scale score of ≥5 for itch after the provocation test."}
  • {"criterion_text":"- Cold Urticaria"}
  • {"criterion_text":"- Cholinergic urticaria: XX"}

Exclusion criteria

  • {"criterion_text":"- Previous use of remibrutinib or other BTK inhibitors."}
  • {"criterion_text":"- Participants who have concomitant CSU at screening. Participants with resolved CSU at the time of screening can be included in the study."}
  • {"criterion_text":"- Participants who have a familial form (e.g familial cold autoinflammatory syndrome, familial cold urticaria) of the target CINDU that is being considered for the participant's inclusion in this study."}
  • {"criterion_text":"- Participants having a more defined other form of inducible urticaria than the target CINDU that is being considered for the participant's inclusion in this study."}
  • {"criterion_text":"- Diseases, other than chronic inducible urticaria, with urticaria or angioedema symptoms including but not limited to urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema"}
  • {"criterion_text":"- Any other skin disease associated with chronic itching that might influence, in the investigator’s opinion, the study evaluations and results (e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) or skin diseases associated with only wheals and no itch e.g asymptomatic dermographism."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- ● Symptomatic dermographism; Proportion of participants with complete response to Total Fric Score (TFS) following the FricTest® 4.0 at Week 12 ● Cold urticaria: proportion of participants with complete response in Critical Temperature Threshold (CTT) following the TempTest® at Week 12. ● Cholinergic urticaria: proportion of participants with itch NRS=0 following the pulse-controlled ergometry test at Week 12","definition_or_measurement_approach":"Measured per cohort-specific tests: Symptomatic dermographism assessed by Total Fric Score (TFS) after FricTest® 4.0; Cold urticaria assessed by Critical Temperature Threshold (CTT) after TempTest®; Cholinergic urticaria assessed by itch Numerical Rating Scale (NRS) = 0 after pulse-controlled ergometry, all evaluated at Week 12."}

Secondary endpoints

  • {"endpoint_text":"- ● Symptomatic dermographism: Change from baseline in Total Fric Score (TFS) following the FricTest® at Week 12 ● Cold urticaria: Change from baseline in Critical temperature threshold (CTT) following the TempTest® at Week 12 ● Cholinergic urticaria: Change from baseline in itch NRS following the pulse-controlled ergometry test at Week 12","definition_or_measurement_approach":"Cohort-specific change from baseline measured by FricTest® TFS (dermographism), TempTest® CTT (cold urticaria), and itch NRS post pulse-controlled ergometry (cholinergic) at Week 12."}
  • {"endpoint_text":"- ● Cholinergic urticaria: Proportion of participants with Physician Global Assessment (PGA) of severity of hives = 0 following the pulse-controlled ergometry test at Week 12.","definition_or_measurement_approach":"PGA assessment after pulse-controlled ergometry; proportion with PGA = 0 at Week 12."}
  • {"endpoint_text":"- ● Symptomatic dermographism: Proportion of participants with complete response to Total Fric Score (TFS) following the FricTest® at Week 24 ● Cold urticaria: Proportion of participants with complete response in Critical temperature Threshold (CTT) following the TempTest® at Week 24 ● Cholinergic urticaria: Proportion of participants with itch NRS=0 following the pulse-controlled ergometry test at Week 24","definition_or_measurement_approach":"Cohort-specific complete response rates measured at Week 24 using FricTest® (TFS), TempTest® (CTT), and pulse-controlled ergometry itch NRS."}
  • {"endpoint_text":"- ● Symptomatic dermographism: Change from baseline in itch NRS following the FricTest® at Week 12 ● Cold urticaria: Change from baseline in itch NRS following the TempTest® at Week 12","definition_or_measurement_approach":"Change from baseline in itch NRS post-provocation (FricTest® or TempTest®) at Week 12."}
  • {"endpoint_text":"- ● Symptomatic dermographism: Proportion of participants with complete response in Total Fric score (TFS) following the FricTest® at Week 2 ● Cold urticaria: Proportion of participants with complete response in Critical temperature threshold (CTT) following the TempTest® at Week 2 ● Cholinergic urticaria: Proportion of participants with itch NRS=0 following the pulse-controlled ergometry test at Week 2","definition_or_measurement_approach":"Early (Week 2) cohort-specific complete response rates following FricTest®, TempTest® or pulse-controlled ergometry."}
  • {"endpoint_text":"- ● Symptomatic dermographism: Change from baseline in Total Fric Score (TFS) following the FricTest® at Week 2 ● Cold urticaria: Change from baseline in the Critical Temperature threshold (CTT) following the TempTest® at Week 2 ● Cholinergic urticaria: Change from baseline in itch NRS following the pulse-controlled ergometry test at Week 2","definition_or_measurement_approach":"Change from baseline in cohort-specific provocation test measures at Week 2."}
  • {"endpoint_text":"- ● Symptomatic dermographism: Change from baseline in itch NRS following the FricTest® at Week 2 ● Cold urticaria: Change from baseline in itch NRS following the TempTest® at Week 2 ● Cholinergic urticaria: Proportion of participants with Physician Global assessment (PGA) of severity of hives=0 following the pulse-controlled ergometry test at Week 2","definition_or_measurement_approach":"Week 2 changes in itch NRS for dermographism and cold urticaria; PGA = 0 proportion for cholinergic urticaria after provocation at Week 2."}
  • {"endpoint_text":"- ● Change from baseline in the weekly most bothersome symptom NRS score on the USDD at Week 12 for each cohort","definition_or_measurement_approach":"Change from baseline in weekly most bothersome symptom NRS on the Urticaria Symptom Daily Diary (USDD) at Week 12 per cohort."}
  • {"endpoint_text":"- ● Proportion of participants with DLQI= 0-1 at Week 12 for each cohort","definition_or_measurement_approach":"Proportion achieving DLQI 0-1 at Week 12 (quality of life measure)."}
  • {"endpoint_text":"- ● Safety endpoints for inducible urticaria subtypes will include but not be limited to: \t● Occurrence of treatment emergent adverse events (AEs) \t● Occurrence of treatment emergent serious adverse events (SAEs) \t● Occurrence of treatment emergent adverse events of special interest (AESIs)","definition_or_measurement_approach":"Safety assessed by recording treatment-emergent AEs, SAEs and AESIs during the study."}

Recruitment

Digital Remote Recruitment
True, digital recruitment is planned/handled by Subject Well Inc. and Publicis Healthcare Communications Group (sponsor third-party duties include 'Digital recruitment for patients').
Planned Sample Size
244
Recruitment Window Months
51
Consent Approach
Informed consent obtained from adult participants (≥18 years) via main ICF documents. Multiple country/language-specific ICFs are provided (examples in French, Romanian, Hungarian, Portuguese, Spanish, German, English, Italian, Polish, Dutch, Slovak among others). No assent procedures for minors are indicated (minors excluded).

Methods

  • Digital recruitment for patients — responsibilities listed for Subject Well Inc. and Publicis Healthcare Communications Group (digital recruitment activities explicitly described in sponsor third-party duties).
  • Country-specific recruitment arrangements and advertisements (K1/K2 recruitment arrangements and K2_Advertisements documents provided; e.g. German K2 advertisements and multiple K1 recruitment arrangement documents per country).

Geography

Total Number Of Sites
59
Total Number Of Participants
102

Netherlands

Earliest CTIS Part Ii Submission Date
18-07-2024
Latest Decision Or Authorization Date
26-08-2024
Processing Time Days
39
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Universitair Medisch Centrum Utrecht
Department Name
1600:Dermatology
Contact Person Name
Heike Rockmann
Contact Person Email
h.rockmann@umcutrecht.nl
Site Name
DC Klinieken Groningen
Department Name
1601:Allergology
Contact Person Name
Richard Oei
Contact Person Email
roei@dcklinieken.nl

Poland

Earliest CTIS Part Ii Submission Date
23-07-2024
Latest Decision Or Authorization Date
30-08-2024
Processing Time Days
38
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Miejski Szpital Zespolony W Olsztynie
Department Name
#1651:Klinika Dermatologii Chorób Przenoszonych Drogą Płciową i Immunologii Klinicznej
Contact Person Name
Agnieszka Owczarczyk-Saczonek
Contact Person Email
aganek@wp.pl
Site Name
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Department Name
#1652: Klinika Dermatologii
Contact Person Name
Adam Reich
Contact Person Email
adamandrzejreich@gmail.com
Site Name
Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy
Department Name
#1654:Klinika Dermatologii, Chorób Przenoszonych Drogą Płciową i Immunodermatologii
Contact Person Name
Luiza Marek-Józefowicz
Contact Person Email
lui06@interia.pl
Site Name
ROYALDERM Agnieszka Nawrocka
Department Name
#1653
Contact Person Name
Witold Owczarek
Contact Person Email
witold.owczarek@dermedicus.pl

Italy

Earliest CTIS Part Ii Submission Date
29-05-2024
Latest Decision Or Authorization Date
27-08-2024
Processing Time Days
90
Number Of Sites
8
Number Of Participants
12

Sites

Site Name
Humanitas Research Hospital
Department Name
#1302:U.O. Centro Medicina Personalizzata: Asma e Allergologia
Contact Person Name
Enrico Marco Heffeler
Contact Person Email
enrico.heffler@hunimed.eu
Site Name
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Department Name
#1308:U.O.C. Pneumologia
Contact Person Name
Rossella Intravaia
Contact Person Email
rossellaintravaia@gmail.com
Site Name
University Hospital Consorziale Policlinico
Department Name
#1306:Clinica Dermatologica
Contact Person Name
Caterina Foti
Contact Person Email
caterina.foti@uniba.it
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
#1307:U.O.S.D. Dermatologia Dipartimento di Medicina
Contact Person Name
Luca Bianchi
Contact Person Email
luca.bianchi@uniroma2.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
#1301:S.C. Dermatologia
Contact Person Name
Silvia Mariel Ferrucci
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
#1304:S.O.D. Clinica di Dermatologia
Contact Person Name
Oriana Simonetti
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
#1305:S.C. Allegologia e Immunologia
Contact Person Name
Jan Walter Volk Schroeder
Site Name
University Hospital Consorziale Policlinico (additional site entry)
Department Name
#1306:Clinica Derm atologica

Slovakia

Earliest CTIS Part Ii Submission Date
04-07-2024
Latest Decision Or Authorization Date
27-08-2024
Processing Time Days
54
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
BeneDerma s.r.o.
Department Name
#1801:Dermatovenerologická ambulancia
Contact Person Name
Regina Paulínyová
Contact Person Email
benederma@gmail.com
Site Name
Fakultna Nemocnica Trnava
Department Name
#1802:Dermatovenerologické oddelenie
Contact Person Name
Peter Kozub
Contact Person Email
peter.kozub.derm@gmail.com
Site Name
Imunoalergologia Jz s.r.o.
Department Name
#1805:Ambulancia v špecializačnom odbore klinická imunológia a alergológia
Contact Person Name
Jana Zelníková
Contact Person Email
janka.zelienka@gmail.com
Site Name
AlergoImuno centrum s.r.o.
Department Name
#1800:Ambulancia klinickej imunológie a alergológie
Contact Person Name
Ivan Hlinka
Contact Person Email
hlinka@centrum.sk

France

Earliest CTIS Part Ii Submission Date
29-05-2024
Latest Decision Or Authorization Date
26-08-2024
Processing Time Days
89
Number Of Sites
10
Number Of Participants
14

Sites

Site Name
Centre Hospitalier Lyon Sud
Department Name
#1100: Clinical Immunology and Allergy Department
Contact Person Name
Frederic Berard
Contact Person Email
Frederic.berard@chu-lyon.fr
Site Name
CHU De Rouen
Department Name
#1102: Dermatology Department
Contact Person Name
Florence Tetart
Contact Person Email
Florence.tetart@chu-rouen.fr
Site Name
Courlancy Sante
Department Name
#1107: Dermatology
Contact Person Name
Ziad Reguiai
Contact Person Email
dr-reguiai@orange.fr
Site Name
Hopital Tenon
Department Name
#1106: Dermatology
Contact Person Name
Angèle Soria
Contact Person Email
angele.soria@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
#1109: Dermatology
Contact Person Name
Claire BERNIER
Contact Person Email
Claire.bernier@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
#1103: Immunology Allergology
Contact Person Name
Isabelle Boccon-Gibod
Contact Person Email
Iboccon-Gibod@chu-grenoble.fr
Site Name
Hopital Saint Eloi
Department Name
#1104: Dermatology
Contact Person Name
Aurélie Du-Thanh
Contact Person Email
a-du_thanh@chu-montpellier.fr
Site Name
University Hospital Of Clermont-Ferrand
Department Name
#1101: Dermatology Department
Contact Person Name
Justine Pasteur
Site Name
Hopital Huriez
Department Name
#1105: Dermatology
Contact Person Name
Delphine Staumont-Salle
Contact Person Email
Delphine.salle@chru-lille.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
#1108: Dermatology
Contact Person Name
Françoise Giordano

Romania

Earliest CTIS Part Ii Submission Date
29-05-2024
Latest Decision Or Authorization Date
02-09-2024
Processing Time Days
96
Number Of Sites
4
Number Of Participants
7

Sites

Site Name
Institutul Regional De Gastroenterologie-Hepatologie Prof. Dr. Octavian Fodor Cluj
Department Name
1751:Allergology and Clinical Immunology
Contact Person Name
Diana Deleanu
Contact Person Email
deleanudiana@yahoo.com
Site Name
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
Department Name
1753:Allergology and Clinical Immunology
Contact Person Name
Liliana Duca
Contact Person Email
liliduca@neomed.org
Site Name
SCMS - Profilaxis SRL
Department Name
1750:Allergology
Contact Person Name
Carmen Panaitescu
Contact Person Email
cbunu@umft.ro
Site Name
Centrul Medical Euromed S.R.L.
Department Name
1752:Dermatovenerology
Contact Person Name
Florica Sandru
Contact Person Email
florysandru@yahoo.com

Hungary

Earliest CTIS Part Ii Submission Date
02-07-2024
Latest Decision Or Authorization Date
02-09-2024
Processing Time Days
60
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
University Of Debrecen
Department Name
1502:Borgyogyaszati Klinika
Contact Person Name
Andrea Szegedi
Contact Person Email
aszegedi@med.unideb.hu
Site Name
Allergo-Derm Bakos Kft.
Department Name
1501
Contact Person Name
Noemi Bakos
Contact Person Email
bakosnoemidr@gmail.com
Site Name
Derma-B Kft.
Department Name
1500
Contact Person Name
Emese Heredi
Contact Person Email
emeseheredi@gmail.com

Portugal

Earliest CTIS Part Ii Submission Date
29-05-2024
Latest Decision Or Authorization Date
13-09-2024
Processing Time Days
106
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
Centro Hospitalar E Universitario De Coimbra E.P.E.
Department Name
#1701: Serviço de Dermatologia e Venereologia
Contact Person Name
Maria Margarida Gonçalo
Contact Person Email
mmgoncalo@gmail.com
Site Name
Centro Hospitalar De Vila Nova De Gaia/Espinho E.P.E.
Department Name
#1702:Serviço de Imunoalergologia
Contact Person Name
Maria Isabel Rosmaninho
Site Name
Centro Hospitalar Universitario De Lisboa Norte E.P.E.
Department Name
#1700:Serviço de Imuno-alergologia
Contact Person Name
Ana Célia Costa Hipólito
Contact Person Email
dra.celiacosta.73@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
29-05-2024
Latest Decision Or Authorization Date
27-08-2024
Processing Time Days
90
Number Of Sites
12
Number Of Participants
18

Sites

Site Name
Hospital General Universitario Dr. Balmis
Department Name
1402:Dermatología
Contact Person Name
Juan Francisco Silvestre Salvador
Contact Person Email
silvestre_jfr@gva.es
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
1406:Dermatología
Contact Person Name
Marta Ferrer Puga
Contact Person Email
mferrerp@unav.es
Site Name
Clinica Universidad De Navarra (Madrid)
Department Name
1406:Dermatología
Contact Person Name
Marta Ferrer Puga
Contact Person Email
mferrerp@unav.es
Site Name
Hospital Arnau De Vilanova De Valencia
Department Name
1407:Dermatología
Contact Person Name
Francisco Javier Miquel Miquel
Contact Person Email
miquel_framiq@gva.es
Site Name
Hospital Universitario Basurto
Department Name
1409:Alergología
Contact Person Name
Ana Belén Arcediano Martinez
Site Name
Clinica Gaias Santiago
Department Name
1411:Dermatología
Contact Person Name
Hae Jin Suh Oh
Contact Person Email
haejin@clinicasuh.com
Site Name
Hospital Universitario Rey Juan Carlos
Department Name
1412:Dermatología
Contact Person Name
Francisco Javier Vicente Martin
Site Name
Hospital Universitario Reina Sofia
Department Name
1403:Dermatología
Contact Person Name
Juan Alberto Ruano Ruiz
Contact Person Email
juanruanoruiz@mac.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
1401:Dermatología
Contact Person Name
Moises Labrador Horrillo
Contact Person Email
moises.labrador@vallhebron.cat
Site Name
Hospital Del Mar
Department Name
1400:Dermatología
Contact Person Name
Anna María Giménez-Arnau
Contact Person Email
22505aga@comb.cat
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
1408:Dermatología
Contact Person Name
Manuel Sanchez Díaz
Contact Person Email
manolo.94.sanchez@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
1404:Dermatología
Contact Person Name
Francisco Javier Ortiz de Frutos
Contact Person Email
javierortiz@aedv.es

Germany

Earliest CTIS Part Ii Submission Date
19-07-2024
Latest Decision Or Authorization Date
27-08-2024
Processing Time Days
39
Number Of Sites
9
Number Of Participants
18

Sites

Site Name
Universitaetsmedizin Goettingen
Department Name
1002: Klinik fuer Dermatologie, Venerologie u. Allergologie
Contact Person Name
Undine Lippert
Site Name
Technische Universitat Dresden
Department Name
1008: Klinik und Poliklinik für Dermatologie
Contact Person Name
Andrea Bauer
Site Name
Elbe Kliniken Stade-Buxtehude Elbe Klinikum Buxtehude gGmbH
Department Name
1006: Klinik für Dermatologie
Contact Person Name
Andreas Kleinheinz
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
1003: Institut für Allergieforschung (IFA)
Contact Person Name
Martin Metz
Contact Person Email
martin.metz@charite.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
1005: Dermatologie/Clinical Research Center
Contact Person Name
Petra Staubach-Renz
Site Name
Medical Center - University Of Freiburg
Department Name
1011: Klinik für Dermatologie und Venerologie
Contact Person Name
Sabine Mueller
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
1004: Allergologie / Universitäts-Hautklinik
Contact Person Name
Sebastian Volc
Site Name
Universitaet Muenster
Department Name
1009: Klinik für Hautkrankheiten
Contact Person Name
Mathias Sulk
Contact Person Email
Mathias.sulk@ukmuenster.de
Site Name
Universitaetsklinikum Schleswig-Holstein
Department Name
1013: Institut für Entzündungsmedizin
Contact Person Name
Tomasz Hawro
Contact Person Email
tomasz.hawro@uksh.de

Sponsor

Primary sponsor

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

Contract research organisations

Name
IQVIA Limited
Name
Parexel International (IRL) Limited
Name
Syneos Health Inc.
Name
Icon Clinical Research Limited
Responsibilities
Statistical analysis for Data Monitoring Committee and interim futility analysis
Name
Medidata Solutions Inc.
Name
Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.
Responsibilities
PK analysis

Third parties

  • {"country":"France","full_name":"Kayentis","duties_or_roles":"PRO formatting, translations and licensing","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Subject Well Inc.","duties_or_roles":"Digital recruitment for patients","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"PRO formatting, translations and licensing","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Ancillary supplies","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Phardis S.r.l.","duties_or_roles":"Local equipment storage","organisation_type":"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":"France","full_name":"SGS France","duties_or_roles":"PK analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Creapharm Clinical Supplies","duties_or_roles":"Destruction of the investigational medicinal products","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Opis S.r.l.","duties_or_roles":"TMF archive Activation sites activities","organisation_type":"Pharmaceutical company"}
  • {"country":"Romania","full_name":"Alliance Healthcare Romania S.R.L.","duties_or_roles":"Destruction of the investigational medicinal products. Medical devices purchasing and distribution to investigational sites.","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"Imaging assessment","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Rti Health Solutions","duties_or_roles":"In-trial interviews","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Komtur Polska Sp. z o.o.","duties_or_roles":"Local purchase of medicinal products (non-IMP)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Publicis Healthcare Communications Group Limited","duties_or_roles":"Digital recruitment for patients","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Statistical analysis for Data Monitoring Committee and interim futility analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Cardiac activity","organisation_type":"Pharmaceutical company"}
  • {"country":"Hungary","full_name":"ADR Logistics Kft.","duties_or_roles":"Drug storage, distribution, and destruction","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"","organisation_type":"Non-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":"China","full_name":"Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.","duties_or_roles":"PK analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eurofins Viracor Biopharma Services Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
LOU064
Active Substance
REMIBRUTINIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Starting Dose
XX mg
Frequency
b.i.d.
Investigational Product Name
Placebo to Remibrutinib (LOU064) XX mg film-coated tablet
Modality
Other

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