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|Monoclonal antibody

Key dates

Initial CTIS Submission Date
05-10-2023
First CTIS Authorization Date
12-02-2024

Trial design

Randomised, omalizumab 300 mg subcutaneous every 4 weeks as active control; placebo arms (matching placebo to remibrutinib 25 mg tablet and placebo to omalizumab) are used as comparators. Phase III trial in Netherlands, France, Spain and others.

Randomised
Yes
Comparator
Omalizumab 300 mg subcutaneous every 4 weeks as active control; placebo arms (matching placebo to Remibrutinib 25 mg tablet and placebo to Omalizumab) are used as comparators.
Target Sample Size
287
Trial Duration For Participant
364

Eligibility

Recruits 287 No vulnerable populations selected (isVulnerablePopulationSelected: false). Participants are adults (≥18 years). Informed consent is required (subject information and informed consent forms submitted per country)..

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false). Participants are adults (≥18 years). Informed consent is required (subject information and informed consent forms submitted per country).

Inclusion criteria

  • {"criterion_text":"-Male and female adult participants ≥18 years of age at the time of signing the informed consent."}
  • {"criterion_text":"-CSU duration for ≥ 6 months prior to screening."}
  • {"criterion_text":"-Diagnosis of CSU inadequately controlled by second generation H1-AH at the time of randomization, defined as: •\tThe presence of itch and hives for ≥6 consecutive weeks prior to screening, despite the use of second-generation H1-AH during this time period. •\tUAS7 score (range 0-42) ≥16, ISS7 score (range 0-21) ≥ 6 and HSS7 score (range 0- 21) ≥ 6 during the 7 days prior to randomization (Day 1)."}
  • {"criterion_text":"-Documentation of hives within three months before randomization."}
  • {"criterion_text":"-Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the study protocol."}
  • {"criterion_text":"-Participants must not have had more than one missing UPDD entry (either morning or evening) in the 7 days prior to randomization (Day 1)."}

Exclusion criteria

  • {"criterion_text":"-Prior exposure to ligelizumab, omalizumab and other biologics with any effect in CSU, including anti-IgE therapies."}
  • {"criterion_text":"-Significant bleeding risk or coagulation disorders."}
  • {"criterion_text":"-History of gastrointestinal bleeding."}
  • {"criterion_text":"-Requirement for anti-platelet or anti-coagulant medication."}
  • {"criterion_text":"-History or current hepatic disease."}
  • {"criterion_text":"-Evidence of clinically significant cardiovascular, 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."}
  • {"criterion_text":"-Evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines."}
  • {"criterion_text":"-Documented history of anaphylaxis."}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Absolute change from baseline in UAS7, ISS7 and HSS7 at Week 12","definition_or_measurement_approach":"Change from baseline in UAS7, ISS7 and HSS7 at Week 12; assessed using weekly Urticaria Activity Score 7 (UAS7), Itch Severity Score 7 (ISS7) and Hives Severity Score 7 (HSS7) measured over the 7 days prior to Week 12."}

Secondary endpoints

  • {"endpoint_text":"-Achievement of UAS7=0 (yes/no) at Week 12","definition_or_measurement_approach":"Proportion of participants achieving complete absence of hives and itch (UAS7 = 0) at Week 12 (yes/no)."}
  • {"endpoint_text":"-Improvement of severity of itch, assessed as absolute change from baseline in ISS7 score at Week 12","definition_or_measurement_approach":"Absolute change from baseline in ISS7 (Itch Severity Score 7) at Week 12."}
  • {"endpoint_text":"-Improvement of severity of hives, assessed as absolute change from baseline in HSS7 score at Week 12","definition_or_measurement_approach":"Absolute change from baseline in HSS7 (Hives Severity Score 7) at Week 12."}
  • {"endpoint_text":"-Absolute change from baseline in UAS7 at Week 12","definition_or_measurement_approach":"Absolute change from baseline in UAS7 (Urticaria Activity Score 7) at Week 12."}
  • {"endpoint_text":"-Occurrence of treatment-emergent adverse events and serious adverse events (SAEs) during the study","definition_or_measurement_approach":"Recording and reporting of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) during the study per standard safety reporting procedures."}

Recruitment

Planned Sample Size
287
Recruitment Window Months
40
Consent Approach
Informed consent obtained from each participant (adults ≥18). Subject information and informed consent forms (L1_ICF) submitted for each country; separate data protection consent and pregnancy follow-up forms available. ICFs are available in multiple languages (examples in the submission: Italian, Polish, Hungarian, French, Spanish, Czech, German, Dutch, English, Bulgarian, Slovak) as per country-specific documentation.

Methods

  • Country-specific recruitment arrangements documents submitted (K1_Recruitment Arrangements per country) and advertisements (K2_Advertisements) — recruitment materials/documents present for DE, IT, PL, HU, FR, ES, CZ, NL, BG, SK (document entries in CTIS).

Geography

Total Number Of Sites
61
Total Number Of Participants
218

Netherlands

Earliest CTIS Part Ii Submission Date
23-01-2024
Latest Decision Or Authorization Date
08-10-2025
Processing Time Days
624
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Universitair Medisch Centrum Utrecht
Department Name
#2601:Reumatologie/Klin. Immunologie en Dermatologie
Principal Investigator Name
Heike Röckmann
Principal Investigator Email
h.rockmann@umcutrecht.nl
Contact Person Name
Heike Röckmann
Contact Person Email
h.rockmann@umcutrecht.nl

France

Earliest CTIS Part Ii Submission Date
22-01-2024
Latest Decision Or Authorization Date
01-09-2025
Processing Time Days
588
Number Of Sites
9
Number Of Participants
35

Sites

Site Name
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis
Department Name
#2058: Service de Dermatologie
Principal Investigator Name
Romain LESBAZEILLES
Principal Investigator Email
Romain.LESBAZEILLES@ght-atlantique17.fr
Contact Person Name
Romain LESBAZEILLES
Site Name
University Hospital Of Clermont-Ferrand
Department Name
#2052: Service Dermatologie
Principal Investigator Name
Justine Pasteur
Principal Investigator Email
jpasteur@chu-clermontferrand.fr
Contact Person Name
Justine Pasteur
Site Name
Tagast 41
Department Name
#2056
Principal Investigator Name
Abdallah Khemis
Principal Investigator Email
dermato@khemis06.fr
Contact Person Name
Abdallah Khemis
Contact Person Email
dermato@khemis06.fr
Site Name
HIA Sainte Anne
Department Name
#2057: Service Dermatologie et vénéréologie
Principal Investigator Name
Thierry Boyé
Principal Investigator Email
thierry.boye@yahoo.fr
Contact Person Name
Thierry Boyé
Contact Person Email
thierry.boye@yahoo.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
#2055: Service Derrmatologie
Principal Investigator Name
Claire Bernier
Principal Investigator Email
claire.bernier@chu-nantes.fr
Contact Person Name
Claire Bernier
Contact Person Email
claire.bernier@chu-nantes.fr
Site Name
Hopital Avicenne
Department Name
#2059: Service de Dermatologie
Principal Investigator Name
Frédéric Caux
Principal Investigator Email
frederic.caux@aphp.fr
Contact Person Name
Frédéric Caux
Contact Person Email
frederic.caux@aphp.fr
Site Name
Centre Hospitalier Lyon Sud
Department Name
#2051: Service d’Allergologie et Immunologie Clinique
Principal Investigator Name
Frédéric Bérard
Principal Investigator Email
frederic.berard@chu-lyon.fr
Contact Person Name
Frédéric Bérard
Contact Person Email
frederic.berard@chu-lyon.fr
Site Name
CHU De Rouen
Department Name
#2053: Service Dermatologie
Principal Investigator Name
Florence Tétart
Principal Investigator Email
florence.tetart@chu-rouen.fr
Contact Person Name
Florence Tétart
Contact Person Email
florence.tetart@chu-rouen.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
#2054: Service de Médecine Interne
Principal Investigator Name
Isabelle Boccon-Gibod
Principal Investigator Email
iboccon-gibod@chu-grenoble.fr
Contact Person Name
Isabelle Boccon-Gibod
Contact Person Email
iboccon-gibod@chu-grenoble.fr

Spain

Earliest CTIS Part Ii Submission Date
26-01-2024
Latest Decision Or Authorization Date
17-09-2025
Processing Time Days
600
Number Of Sites
10
Number Of Participants
20

Sites

Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
#2360: Servicio de dermatología
Principal Investigator Name
Manuel Sánchez Díaz
Contact Person Name
Manuel Sánchez Díaz
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
#2359: Servicio de dermatología
Principal Investigator Name
Javier Pedraz Muñoz
Principal Investigator Email
javierpedraz78@gmail.com
Contact Person Name
Javier Pedraz Muñoz
Contact Person Email
javierpedraz78@gmail.com
Site Name
El Hospital Universitario De Gran Canaria Dr. Negrin
Department Name
#2353: Servicio de dermatología
Principal Investigator Name
Irene Castaño Gonzalez
Principal Investigator Email
icasgong@gobiernodecanarias.org
Contact Person Name
Irene Castaño Gonzalez
Site Name
Hospital Universitari Vall D Hebron
Department Name
#2352: Servicio de alergología
Principal Investigator Name
Moises Labrador Horrillo
Principal Investigator Email
moises.labrador@vallhebron.cat
Contact Person Name
Moises Labrador Horrillo
Contact Person Email
moises.labrador@vallhebron.cat
Site Name
Hospital Universitario Reina Sofia
Department Name
#2355: Servicio de dermatología
Principal Investigator Name
Juan Alberto Ruano Ruiz
Principal Investigator Email
juanruanoruiz@mac.com
Contact Person Name
Juan Alberto Ruano Ruiz
Contact Person Email
juanruanoruiz@mac.com
Site Name
Hospital Del Mar
Department Name
#2351: Servicio de dermatología
Principal Investigator Name
Ana María Gimenez Arnau
Principal Investigator Email
22505aga@comb.cat
Contact Person Name
Ana María Gimenez Arnau
Contact Person Email
22505aga@comb.cat
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
#2354: Servicio de dermatología
Principal Investigator Name
Mercedes Rodriguez Serna
Principal Investigator Email
rodriguez_mer@gva.es
Contact Person Name
Mercedes Rodriguez Serna
Contact Person Email
rodriguez_mer@gva.es
Site Name
Hospital Arnau De Vilanova De Valencia
Department Name
#2356: Servicio de dermatología
Principal Investigator Name
Francisco Javier Miquel Miquel
Principal Investigator Email
fjmiquel0406@gmail.com
Contact Person Name
Francisco Javier Miquel Miquel
Contact Person Email
fjmiquel0406@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
#2357: Servicio de alergología
Principal Investigator Name
Joan Bartra Tomás
Principal Investigator Email
jbartra@clinic.cat
Contact Person Name
Joan Bartra Tomás
Contact Person Email
jbartra@clinic.cat
Site Name
Hospital Universitario La Paz
Department Name
#2358: Servicio de alergología
Principal Investigator Name
Maria Teresa Caballero Molina
Principal Investigator Email
mteresa.caballero@ciberer.es
Contact Person Name
Maria Teresa Caballero Molina
Contact Person Email
mteresa.caballero@ciberer.es

Czechia

Earliest CTIS Part Ii Submission Date
26-01-2024
Latest Decision Or Authorization Date
26-09-2025
Processing Time Days
609
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Dermafit Centrum s.r.o.
Department Name
#2456 Dermatovenerologie
Principal Investigator Name
Petra Brodska
Principal Investigator Email
brodska@dermafit.cz
Contact Person Name
Petra Brodska
Contact Person Email
brodska@dermafit.cz
Site Name
Fakultni Nemocnice U Sv Anny V Brne
Department Name
#2452 Dermatovenerologická klinika
Principal Investigator Name
Miroslav Necas
Principal Investigator Email
miroslav.necas@fnusa.cz
Contact Person Name
Miroslav Necas
Contact Person Email
miroslav.necas@fnusa.cz
Site Name
Fakultní Nemocnice Královské Vinohrady
Department Name
#2455 Dermatovenerologická klinika
Principal Investigator Name
Dana Prusikova
Principal Investigator Email
dana.prusikova@fnkv.cz
Contact Person Name
Dana Prusikova
Contact Person Email
dana.prusikova@fnkv.cz

Netherlands

Earliest CTIS Part Ii Submission Date
23-01-2024
Latest Decision Or Authorization Date
08-10-2025
Processing Time Days
624
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Universitair Medisch Centrum Utrecht
Department Name
#2601:Reumatologie/Klin. Immunologie en Dermatologie
Principal Investigator Name
Heike Röckmann
Principal Investigator Email
h.rockmann@umcutrecht.nl
Contact Person Name
Heike Röckmann
Contact Person Email
h.rockmann@umcutrecht.nl

Germany

Earliest CTIS Part Ii Submission Date
22-01-2024
Latest Decision Or Authorization Date
29-01-2026
Processing Time Days
738
Number Of Sites
18
Number Of Participants
70

Sites

Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
2167: Allergologie / Universitaets-Hautklinik
Principal Investigator Name
Sebastian Volc
Principal Investigator Email
sebastian.volc@med.uni-tuebingen.de
Contact Person Name
Sebastian Volc
Site Name
Martin-Luther-Universitaet Halle-Wittenberg
Department Name
2157: Department for clinical studies dermatology
Principal Investigator Name
Burkhard Kreft
Principal Investigator Email
burkhard.kreft@uk-halle.de
Contact Person Name
Burkhard Kreft
Contact Person Email
burkhard.kreft@uk-halle.de
Site Name
Elbe Kliniken Stade-Buxtehude Elbe Klinikum Buxtehude gGmbH
Department Name
2169: Klinik fuer Dermatologie
Principal Investigator Name
Andreas Karl Kleinheinz
Principal Investigator Email
Andreas.Kleinheinz@elbekliniken.de
Contact Person Name
Andreas Karl Kleinheinz
Site Name
Katholisches Klinikum Bochum gGmbH
Department Name
2173: Klinik fuer Dermatologie, Venerologie und Allergologie
Principal Investigator Name
Klara Bastek
Principal Investigator Email
Klara.bastek@klinikum-bochum.de
Contact Person Name
Klara Bastek
Site Name
Universitaet Leipzig
Department Name
2160: Klinik fuer Dermatologie, Venerologie und Allergologie
Principal Investigator Name
Jan-Christoph Simon
Principal Investigator Email
jan.simon@medizin.uni-leipzig.de
Contact Person Name
Jan-Christoph Simon
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
2164: Klinik und Poliklinik fuer Dermatologie und Allergologie am Biederstein
Principal Investigator Name
Knut Brockow
Principal Investigator Email
Knut.Brockow@tum.de
Contact Person Name
Knut Brockow
Contact Person Email
Knut.Brockow@tum.de
Site Name
Klinische Forschung Osnabrueck
Department Name
2165
Principal Investigator Name
Sylvia Pauser
Principal Investigator Email
sylvia.pauser@klifos.de
Contact Person Name
Sylvia Pauser
Contact Person Email
sylvia.pauser@klifos.de
Site Name
Universitaetsmedizin Goettingen
Department Name
2171: Klinik fuer Dermatologie, Venerologie und Allergologie
Principal Investigator Name
Undine Lippert
Principal Investigator Email
undine.lippert@med.uni-goettingen.de
Contact Person Name
Undine Lippert
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
2153: Hautklinik und Poliklinik
Principal Investigator Name
Petra Staubach-Renz
Principal Investigator Email
Petra.staubach@unimedizin-mainz.de
Contact Person Name
Petra Staubach-Renz
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
2152: Institut fuer Allergieforschung
Principal Investigator Name
Martin Metz
Principal Investigator Email
martin.metz@charite.de
Contact Person Name
Martin Metz
Contact Person Email
martin.metz@charite.de
Site Name
Technische Universitat Dresden
Department Name
2154: Klinik und Poliklinik fuer Dermatologie
Principal Investigator Name
Andrea Bauer
Principal Investigator Email
Andrea.Bauer@uniklinikum-dresden.de
Contact Person Name
Andrea Bauer
Site Name
Universitaetsklinikum Schleswig-Holstein
Department Name
2161: Institut fuer Entzuendungsmedizin
Principal Investigator Name
Tomasz Hawro
Principal Investigator Email
tomasz.hawro@uksh.de
Contact Person Name
Tomasz Hawro
Contact Person Email
tomasz.hawro@uksh.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
2159: Dermatology
Principal Investigator Name
Knut Schaekel
Principal Investigator Email
StudienSchaekel.haut@med.uni-heidelberg.de
Contact Person Name
Knut Schaekel
Site Name
Medical Center - University Of Freiburg
Department Name
2156: Department of Dermatology and Venerology
Principal Investigator Name
Sabine Mueller
Contact Person Name
Sabine Mueller
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
2163: Klinik und Poliklinik fuer Dermatologie und Allergologie
Principal Investigator Name
Benjamin Kendziora
Principal Investigator Email
Benjamin.kendziora@med.uni-muenchen.de
Contact Person Name
Benjamin Kendziora
Site Name
Thermalsole und Schwefelbad Bentheim GmbH
Department Name
2151: Klinisches Studienzentrum
Principal Investigator Name
Athanasios Tsianakas
Principal Investigator Email
a.tsianakas@fk-bentheim.de
Contact Person Name
Athanasios Tsianakas
Contact Person Email
a.tsianakas@fk-bentheim.de
Site Name
MENSINGDERMAresearch GmbH
Department Name
2158
Principal Investigator Name
Christian Mensing
Principal Investigator Email
ch.mensing@mensing-derma.de
Contact Person Name
Christian Mensing
Contact Person Email
ch.mensing@mensing-derma.de

Bulgaria

Earliest CTIS Part Ii Submission Date
02-02-2024
Latest Decision Or Authorization Date
29-01-2026
Processing Time Days
727
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Alexandrovska University Hospital
Department Name
#2401: Clinic of Clinical Allergology
Principal Investigator Name
Maria Staevska - Kotasheva
Principal Investigator Email
mari66sta@gmail.com
Contact Person Name
Maria Staevska - Kotasheva
Contact Person Email
mari66sta@gmail.com
Site Name
Medical Centre Iskar EOOD
Department Name
#2403
Principal Investigator Name
Mariana Mandazhieva-Pepelanova
Principal Investigator Email
m_mandajieva@abv.bg
Contact Person Name
Mariana Mandazhieva-Pepelanova
Contact Person Email
m_mandajieva@abv.bg
Site Name
Medical Center Research Expert OOD
Department Name
#2402:
Principal Investigator Name
Cvetanka Odzhakova – Atanasova
Principal Investigator Email
odjakova@hotmail.com
Contact Person Name
Cvetanka Odzhakova – Atanasova
Contact Person Email
odjakova@hotmail.com

Slovakia

Earliest CTIS Part Ii Submission Date
23-01-2024
Latest Decision Or Authorization Date
31-03-2026
Processing Time Days
798
Number Of Sites
4
Number Of Participants
25

Sites

Site Name
Sanare spol. s r.o.
Department Name
2253: Dermatovenerologická ambulancia
Principal Investigator Name
Hana Zelenková
Principal Investigator Email
zelenkova@vl.sk
Contact Person Name
Hana Zelenková
Contact Person Email
zelenkova@vl.sk
Site Name
Fakultna Nemocnica Trnava
Department Name
2251: Dermatovenerologická ambulancia
Principal Investigator Name
Peter Kozub
Principal Investigator Email
peter.kozub.derm@gmail.com
Contact Person Name
Peter Kozub
Contact Person Email
peter.kozub.derm@gmail.com
Site Name
Maxderm s.r.o.
Department Name
2258: Dermatovenerologická ambulancia
Principal Investigator Name
Renáta Hodabová
Principal Investigator Email
renata.hodabova@gmail.com
Contact Person Name
Renáta Hodabová
Contact Person Email
renata.hodabova@gmail.com
Site Name
AlergoImuno centrum s.r.o.
Department Name
2254: Ambulancia klinickej imunológie a alergológie
Principal Investigator Name
Ivan Hlinka
Principal Investigator Email
hlinka@centrum.sk
Contact Person Name
Ivan Hlinka
Contact Person Email
hlinka@centrum.sk

Poland

Earliest CTIS Part Ii Submission Date
25-01-2024
Latest Decision Or Authorization Date
08-09-2025
Processing Time Days
592
Number Of Sites
5
Number Of Participants
23

Sites

Site Name
MT Medic Specjalistyczna Praktyka Lekarska Tomas Stapiński
Department Name
2652: Dermatologia i Wenerologia
Principal Investigator Name
Anna Rajchel
Principal Investigator Email
Kontakt@mtmedic.pl
Contact Person Name
Anna Rajchel
Contact Person Email
Kontakt@mtmedic.pl
Site Name
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Department Name
2655: Klinika Dermatologii
Principal Investigator Name
Irena Walecka-Herniczek
Principal Investigator Email
dermatologia@cskmswia.gov.pl
Contact Person Name
Irena Walecka-Herniczek
Contact Person Email
dermatologia@cskmswia.gov.pl
Site Name
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Department Name
2656: Dermatologia i Wenerologia
Principal Investigator Name
Beata Imko-Walczuk
Principal Investigator Email
b.walczuk@pihouse.pl
Contact Person Name
Beata Imko-Walczuk
Contact Person Email
b.walczuk@pihouse.pl
Site Name
Specjalistyczna Przychodnia Lekarska Alergo Med Sp. z o.o.
Department Name
2653: Dermatologia
Principal Investigator Name
Danuta Mądra-Rogacka
Principal Investigator Email
dmadrarogacka@gmail.com
Contact Person Name
Danuta Mądra-Rogacka
Contact Person Email
dmadrarogacka@gmail.com
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
2651: Klinika Dermatologii, Wenerologii i Alergologii
Principal Investigator Name
Roman Nowicki
Principal Investigator Email
dermatologia@gumed.edu.pl
Contact Person Name
Roman Nowicki
Contact Person Email
dermatologia@gumed.edu.pl

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
Name
Icon Clinical Research Limited
Name
IQVIA Limited
Responsibilities
Management of drug supply logistics, dispensing and unblinding.
Name
Syneos Health Inc.

Third parties

  • {"country":"Hungary","full_name":"SYNLAB Hungary Kft.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"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":"Hungary","full_name":"Opt-X-Pense Kft.","duties_or_roles":"Patient compensation","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Bulgaria","full_name":"S & D Pharma Logistics BG EOOD","duties_or_roles":"Storage and destruction of IMP","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eurofins Viracor Biopharma Services Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Hungary","full_name":"ADR Logistics Kft.","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":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Labor Dr. Spranger","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"DHL Supply Chain Operations GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Bulgaria","full_name":"World Courier Bulgaria Ltd","duties_or_roles":"IMP transportation from sites","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Opis S.r.l.","duties_or_roles":"TMF archive","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Kayentis","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Poltraf Sp. z o.o.","duties_or_roles":"Transport of drugs into clinical trials from Novartis warehouse to sites","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":"Eresearchtechnology Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"SGS France","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Slovakia","full_name":"Movianto Slovensko s.r.o.","duties_or_roles":"Drug storage, distribution, and destruction","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Management of drug supply logistics, dispensing and unblinding.","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Pregnancy testing kit provision","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Translation licensing and formatting of PROs","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
LOU064
Active Substance
Remibrutinib
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Investigational product (sponsor product code LOU064) - prodAuthStatus indicates sponsor submission (PRD10219598)
Starting Dose
25 mg b.i.d.
Dose Levels
25 mg b.i.d.
Frequency
b.i.d.
Maximum Dose
50 mg (maxDailyDoseAmount 50 mg)
Investigational Product Name
OMALIZUMAB
Active Substance
Omalizumab
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
Authorised product reference in dossier (scientificProductEvCode SCP16966521, prodAuthStatus 2)
Starting Dose
300 mg q4w
Dose Levels
300 mg every 4 weeks
Frequency
Every 4 weeks
Maximum Dose
300 mg per administration (maxDailyDoseAmount 300 mg)

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