Clinical trial • Phase III • Immunology|Dermatology

REMIBRUTINIB for Hidradenitis suppurativa

Phase III trial of REMIBRUTINIB for Hidradenitis suppurativa.

Overview

Trial Therapeutic Area
Immunology|Dermatology
Trial Disease
Hidradenitis suppurativa
Trial Stage
Phase III
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
21-01-2025
First CTIS Authorization Date
12-05-2025

Trial design

Randomised, placebo to remibrutinib (lou064) 0 mg matching film-coated tablet (placebo arm); remibrutinib (lou064) two active dose arms (two doses referenced as xx mg and xx mg in study documentation; exact doses not specified in the provided data).-controlled Phase III trial in Czechia, Greece, Romania and others.

Randomised
Yes
Comparator
Placebo to remibrutinib (lou064) 0 mg matching film-coated tablet (placebo arm); remibrutinib (LOU064) two active dose arms (two doses referenced as XX mg and XX mg in study documentation; exact doses not specified in the provided data).
Target Sample Size
282
Trial Duration For Participant
476

Eligibility

Recruits 282 paediatric patients.

Vulnerable Population
Adolescents are included (participants ≥ 12 to < 18 years). For participants aged ≥ 12 to < 18 years the parent’s or legal guardian’s signed written informed consent and the child’s assent, if appropriate, must be obtained before any assessment is performed. If a participant reaches the legal age for consent during the study they must sign the corresponding study ICF at the next study visit.

Inclusion criteria

  • {"criterion_text":"- Signed informed consent must be obtained prior to participation in the study. For participants aged ≥ 12 to < 18 years: parent’s or legal guardian’s signed written informed consent and child’s assent, if appropriate, must be obtained before any assessment is performed. Of note, if the participant reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.\n- Male and female participants ≥ 12 years of age at the time of signing the informed consent forms.\n- Diagnosis of Hidradenitis Suppurativa (HS) based on clinical history and physical examination for at least 6 months prior to the Baseline visit.\n- Participants with moderate to severe HS at baseline defined as: •\tA total of at least 5 AN, i.e. abscesses and/or inflammatory nodules AND •\tInflammatory lesions should affect at least 2 distinct anatomic areas (e.g., left and right axillae)"}

Exclusion criteria

  • {"criterion_text":"- Presence of more than 20 fistulae/tunnels (both draining and non-draining) in total at baseline.\n- Any active skin disease or conditions that may interfere with the assessment of HS.\n- Previous exposure to remibrutinib or other BTK inhibitors.\n- Use of other investigational drugs within 5 half-lives, or within 30 days (for small molecules) prior to randomization, or until the pharmacodynamic effect has returned to baseline (for biologics), whichever is longer.\n- Significant bleeding risk or coagulation disorders\n- History of gastrointestinal bleeding.\n- Requirement for anti-platelet (except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d) or anti-coagulant medication.\n- History or current hepatic disease.\n- 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.\n- History of hypersensitivity to any of the study drug constituents.\n- Known or suspected infectious disease that is active, chronic or recurrent which precludes the participant from participating in the trial as per investigator's assessment. These infectious diseases include and are not limited to opportunistic infections (e.g., tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis) and/or known or suspected Human Immunodeficiency Virus (HIV) infection. Should it be required by local regulations and/or considered appropriate by the investigator, an HIV test can be performed to confirm eligibility\n- History of live attenuated vaccine administration within 6 weeks prior to randomization or requirement to receive these vaccinations at any time while on study treatment\n- Major surgery within 8 weeks prior to screening or planned surgery for the duration of the study."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Achievement of HiSCR50 at Week 16. HiSCR50 is defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses and in the number of draining tunnels/fistulae compared to baseline.","definition_or_measurement_approach":"HiSCR50 is defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses and in the number of draining tunnels/fistulae compared to baseline."}

Secondary endpoints

  • {"endpoint_text":"- Achievement of AN50 at Week 16. AN50 is defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count compared to baseline\n- Percentage change from baseline in IHS4 at Week 16\n- Achievement of HiSCR75 at Week 16. HiSCR75 is defined as at least a 75% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses and in the number of draining tunnels/fistulae compared to baseline.\n- Flaring up to Week 16. Flare is defined as at least a 25% increase in AN count with a minimum increase of 2 AN relative to baseline.\n- Achievement of HiSCR50 at Week 8.\n- Achievement of HiSCR90 at Week 16. HiSCR90 is defined as at least a 90% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses and in the number of draining tunnels/fistulae compared to baseline\n- Achievement of NRS30 at Week 16, among participants with baseline NRS ≥ 3 (pooled data from studies CLOU064J12301 and CLOU064J12302). NRS30 is defined as at least a 30% reduction and at least 2-unit reduction from baseline in Patient's Global Assessment of Skin Pain - at worst over the past 7 days\n- Occurrence of treatment emergent adverse events and serious adverse events during the study","definition_or_measurement_approach":"AN50: ≥50% decrease in Abscess and Inflammatory Nodule (AN) count vs baseline. IHS4: percent change from baseline in the IHS4 score at Week 16. HiSCR75/HiSCR90 definitions: ≥75% and ≥90% decreases respectively in AN count with no increase in abscesses or draining tunnels/fistulae vs baseline. Flare: ≥25% increase in AN count with minimum increase of 2 AN vs baseline. HiSCR50 at Week 8 uses the HiSCR50 definition. NRS30: ≥30% and ≥2-unit reduction from baseline in Patient's Global Assessment of Skin Pain (worst over past 7 days) among baseline NRS ≥3. Safety endpoints: occurrence of treatment-emergent adverse events and serious adverse events during study."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
282
Recruitment Window Months
41
Consent Approach
Signed informed consent must be obtained prior to participation. Adults provide written informed consent. For participants aged ≥ 12 to < 18 years: parent’s or legal guardian’s signed written informed consent and the child’s assent (if appropriate) must be obtained before any assessment. If a participant reaches the age of consent during the study they must sign the corresponding study ICF at the next study visit. Age-specific documents (adolescent assent, parent/legal guardian ICFs, pregnancy follow-up ICFs, separate data protection consent, optional assessment ICFs) are provided. ICFs and assent/parent forms are available in multiple languages and country-specific versions (examples present: English, German, French, Spanish, Dutch, Czech, Greek, Hungarian, Polish, Romanian and country-specific ICFs).

Methods

  • Digital patient recruitment (Subject Well Inc. listed with duty: 'Digital Patient recruitment').
  • Country-specific recruitment arrangements documented via K1 recruitment arrangements (country K1 documents present for participating countries) and country-language advertisements (K2 advertisement documents).
  • PRO/ePRO and patient-facing diaries for remote data capture and engagement (Kayentis, Medidata provide PRO management and ePRO/data collection via tablet).
  • Patient convenience and logistics support (Greenphire and Medical Equipment Supplies And Management Limited referenced for 'Patient Convenience' and supply of freezers and cooler bags).

Geography

Total Number Of Sites
61
Total Number Of Participants
250

Czechia

Earliest CTIS Part Ii Submission Date
30-04-2025
Latest Decision Or Authorization Date
15-05-2025
Processing Time Days
15
Number Of Sites
8
Number Of Participants
19

Sites

Site Name
DermaMedEst s.r.o.
Department Name
#7108: DermaMedEst
Contact Person Name
Lucie Jaresova
Contact Person Email
jaresova@dermamedest.com
Site Name
Fakultni Nemocnice V Motole
Department Name
#7103: Dermatovenerologicke oddeleni
Contact Person Name
Alena Machovcova
Contact Person Email
alena.machovcova@fnmotol.cz
Site Name
Karlovarska krajska nemocnice a.s.
Department Name
#7102: Kozni oddeleni
Contact Person Name
Tomas Pospisil
Contact Person Email
tomas.pospisil@kkn.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
#7107: Dermatovenerologická klinika
Contact Person Name
Jorga Fialova
Contact Person Email
jorga.fialova@vfn.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
#7101: Dermatovenerologická klinika
Contact Person Name
Spyridon Gkalpakiotis
Contact Person Email
spyridon.gkalpakiotis@fnkv.cz
Site Name
Dermafit Centrum s.r.o.
Department Name
#7109: Dermafit Centrum
Contact Person Name
Petra Brodska
Contact Person Email
brodska@dermafit.cz
Site Name
Fakultni Nemocnice Bulovka
Department Name
#7106: Dermatovenerologická klinika
Contact Person Name
Filip Rob
Contact Person Email
filip.rob@bulovka.cz
Site Name
DermaMedEst s.r.o. (additional listed site entries consolidated)
Department Name
#7108: DermaMedEst

Greece

Earliest CTIS Part Ii Submission Date
11-04-2025
Latest Decision Or Authorization Date
14-05-2025
Processing Time Days
33
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Andreas Syngros Hospital Of Venereal And Dermatological Diseases
Department Name
#7251 : Department of Dermatology- Venereology
Contact Person Name
Alexander Stratigos
Contact Person Email
alstrat2@gmail.com
Site Name
University General Hospital Attikon
Department Name
#7253: 2nd Department of Dermatology-Venereology, NKUA
Contact Person Name
Alexandros Katoulis
Contact Person Email
alexanderkatoulis@yahoo.co.uk
Site Name
General Hospital Of Thessaloniki Papageorgiou
Department Name
#7252: 2nd department of Dermatology - Venereology
Contact Person Name
Elizabeth Lazaridou
Contact Person Email
bethlaz@auth.gr

Romania

Earliest CTIS Part Ii Submission Date
20-04-2025
Latest Decision Or Authorization Date
19-05-2025
Processing Time Days
29
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Dr Tirziu Dermato-Chirurgie S.R.L.
Department Name
7456:Dermato-Venerology
Contact Person Name
Claudia Tirziu
Contact Person Email
claudiatirziu@gmail.com
Site Name
Centrul Medical Euromed S.R.L.
Department Name
#7455: Dermato-Venerology
Contact Person Name
Florica Sandru
Contact Person Email
florysandru@yahoo.com
Site Name
Spitalul Clinic Colentina Bucuresti
Department Name
#7453: Dermato-Venerology
Contact Person Name
Maria Magdalena Constantin
Contact Person Email
drmagdadinu@yahoo.com
Site Name
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila
Department Name
7457:Dermato-Venerology
Contact Person Name
Marcela Poenaru
Contact Person Email
marcelapoenaru@yahoo.com

Austria

Earliest CTIS Part Ii Submission Date
23-04-2025
Latest Decision Or Authorization Date
14-05-2025
Processing Time Days
21
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Ordensklinikum Linz GmbH
Department Name
#7001: Dermatologische Abteilung
Contact Person Name
Barbara Ebner

Germany

Earliest CTIS Part Ii Submission Date
26-02-2025
Latest Decision Or Authorization Date
13-05-2025
Processing Time Days
76
Number Of Sites
14
Number Of Participants
74

Sites

Site Name
Goethe University Frankfurt
Department Name
#7201;Universitaetsklinikum Frankfurt Klinik fuer Dermatologie, Venerologie und Allergologie
Contact Person Name
Andreas Pinter
Contact Person Email
pinter-klifo-ffm@gmx.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
#7203;Allergologie / Universitäts-Hautklinik
Contact Person Name
Matthias Hahn
Site Name
Universitaet Leipzig
Department Name
#7212;Klinik für Dermatologie, Venerologie und Allergologie Klinische Forschungseinheit
Contact Person Name
Jan-Christoph Simon
Site Name
Thermalsole und Schwefelbad Bentheim GmbH
Department Name
#7214;Dermatologie
Contact Person Name
Athanasios Tsianakas
Contact Person Email
a.tsianakas@fk-bentheim.de
Site Name
Hms GmbH
Department Name
#7217;Hautmedizin-Saar-Science
Contact Person Name
Sebastian Zimmer
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
#7207;Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen (IVDP)
Contact Person Name
Matthias Augustin
Contact Person Email
m.augustin@uke.de
Site Name
Medical Center - University Of Freiburg
Department Name
#7202;Klinik für Dermatologie und Venerologie
Contact Person Name
Monica Moebes
Site Name
Havelklinik GmbH & Co. KG
Department Name
#7211;Havelklinik GmbH & Co. KG im Artemed-Klinikverbund Zentrum für Dermatochirurgie
Contact Person Name
Sylke Schneider-Burrus
Site Name
Universitaetsklinikum Essen AöR
Department Name
#7206;Universitaetsklinikum Essen KlinikundPoliklinikfürDermatologie,VenerologieundAllergologie
Contact Person Name
Wiebke Sondermann
Contact Person Email
wiebke.sondermann@uk-essen.de
Site Name
Klinikum Dortmund gGmbH
Department Name
#7213;Hautklinik
Contact Person Name
Laura Susok
Contact Person Email
Laura.susok@klinikumdo.de
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
#7204;Klinik für Deermatologie
Contact Person Name
Norman-Philipp Hoff
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
#7209;Institut für Entzündungsmedizin
Contact Person Name
Diamant Thaci
Contact Person Email
diamant.thaci@uksh.de
Site Name
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Department Name
#7208;Klinik und Poliklinik für Dermatologie Allergologie am Biederstein
Contact Person Name
Thomas Volz
Contact Person Email
thomas.volz@mri.tum.de
Site Name
Muehlenkreiskliniken AöR
Department Name
#7215;Klinik fuer Dermatologie HautTumorCentrum
Contact Person Name
Mareike Alter

Hungary

Earliest CTIS Part Ii Submission Date
31-03-2025
Latest Decision Or Authorization Date
14-05-2025
Processing Time Days
44
Number Of Sites
7
Number Of Participants
20

Sites

Site Name
University Of Szeged
Department Name
#7301:Borgyogyaszati es Allergologiai Klinika
Contact Person Name
Rolland Gyulai
Contact Person Email
gyulai.rolland@med.u-szeged.hu
Site Name
Bacs-Kiskun Varmegyei Oktatokorhaz
Department Name
#7306:Borgyogyaszati Osztaly
Contact Person Name
Ivan Orojan
Contact Person Email
orojani@kmk.hu
Site Name
University Of Debrecen
Department Name
#7302:Borgyogyaszati Klinika
Contact Person Name
Andrea Szegedi
Contact Person Email
aszegedi@med.unideb.hu
Site Name
Semmelweis University
Department Name
#7304:Bor- es Nemikortani Klinika
Contact Person Name
Peter Hollo
Contact Person Email
hollo.peter@semmelweis.hu
Site Name
Derma-B Kft.
Department Name
#7310
Contact Person Name
Emese Heredi
Contact Person Email
emeseheredi@gmail.com
Site Name
Obudai Egeszseguegyi Centrum Kft.
Department Name
#7309
Contact Person Name
Beata Bakos
Contact Person Email
drbakosbea@gmail.com
Site Name
University Of Pecs
Department Name
#7305:Bor Nemikortani es Onkodermatologiai Klinika
Contact Person Name
Zsuzsanna Lengyel
Contact Person Email
lengyel.zsuzsanna@pte.hu

France

Earliest CTIS Part Ii Submission Date
18-03-2025
Latest Decision Or Authorization Date
16-05-2025
Processing Time Days
59
Number Of Sites
7
Number Of Participants
45

Sites

Site Name
Courlancy Sante
Department Name
#7156:Dermatology and Clinical research
Contact Person Name
Ziad Reguiai
Contact Person Email
Dr-reguiai@orange.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
#7154:Dermatology
Contact Person Name
Emilie Bernaut
Contact Person Email
Emilie.brenaut@chu-brest.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
#7157:Dermatology
Contact Person Name
Serge Boulinguez
Contact Person Email
Boulinguez.s@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
#7153:Dermatology
Contact Person Name
Anne-Bénédicte Duval-Modeste
Site Name
Tagast 41
Department Name
#7152:Dermatology & Venerology
Contact Person Name
Abdallah Khemis
Contact Person Email
Dermato@khemis06.fr
Site Name
Hospices Civils De Lyon
Department Name
#7151:Dermatology
Contact Person Name
Axel Villani
Contact Person Email
Axel.villani@chu-lyon.fr
Site Name
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis
Department Name
#7155:Dermatology & Venerology
Contact Person Name
Cécile Frenard

Poland

Earliest CTIS Part Ii Submission Date
11-04-2025
Latest Decision Or Authorization Date
19-05-2025
Processing Time Days
38
Number Of Sites
3
Number Of Participants
13

Sites

Site Name
Klinika Ambroziak Sp. z o.o.
Department Name
7404:Klinika Ambroziak Dermatologia
Contact Person Name
Justyna Skibinska
Site Name
Royalderm Agnieszka Nawrocka
Department Name
7402
Contact Person Name
Witold Owczarek
Contact Person Email
witold.owczarek@dermedicus.pl
Site Name
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Department Name
7403:Klinika Dermatologii
Contact Person Name
Irena Walecka-Herniczek
Contact Person Email
irena.walecka@cskmswia.gov.pl

Spain

Earliest CTIS Part Ii Submission Date
16-04-2025
Latest Decision Or Authorization Date
14-05-2025
Processing Time Days
28
Number Of Sites
10
Number Of Participants
38

Sites

Site Name
El Hospital Universitario De Gran Canaria Dr. Negrin
Department Name
#7503: Servicio Dermatología
Contact Person Name
Elena Castro González
Site Name
Complexo Hospitalario Universitario De Pontevedra
Department Name
#7510: Servicio Dermatología
Contact Person Name
Laura Salgado Boquete
Contact Person Email
laurasalgado.derma@gmail.com
Site Name
Hospital General De Granollers
Department Name
#7505: Servicio Dermatología
Contact Person Name
Jorge Romaní de Gabriel
Contact Person Email
jromani@fphag.org
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
#7507: Servicio Dermatología
Contact Person Name
Lara Ferrándiz Pulido
Contact Person Email
lferrandiz@e-derma.org
Site Name
Grupo Dermatologico Y Estetico Pedro Jaen S.A.
Department Name
#7502: Servicio Dermatología
Contact Person Name
Álvaro González Cantero
Contact Person Email
alvarogc261893@hotmail.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
#7504: Servicio Dermatología
Contact Person Name
Eva Vilarrasa Rull
Contact Person Email
EVilarrasa@santpau.cat
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
#7508: Servicio Dermatología
Contact Person Name
Rafael Botella Estrada
Contact Person Email
rbotellaes@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
#7509: Servicio Dermatología
Contact Person Name
Raquel Rivera Díaz
Contact Person Email
raquel.rivera@salud.madrid.org
Site Name
University Hospital Son Espases
Department Name
#7506: Servicio Dermatología
Contact Person Name
Juan Gabriel Garcia Ladaria
Contact Person Email
jgarcias@ssib.es
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
#7501: Servicio Dermatología
Contact Person Name
Alejandro Molina Leyva

Belgium

Earliest CTIS Part Ii Submission Date
11-04-2025
Latest Decision Or Authorization Date
04-06-2025
Processing Time Days
54
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Centre hospitalier universitaire de Liege
Department Name
#7053: Dermatology
Contact Person Name
Arjen Nikkels
Contact Person Email
af.nikkels@chuliege.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
#7054: Dermatology
Contact Person Name
Pierre-Dominique Ghislain
Site Name
Hopital Erasme
Department Name
#7052: Dermatology
Contact Person Name
Farida Benhadou
Contact Person Email
Farida.Benhadou@hubruxelles.be
Site Name
UZ Leuven
Department Name
#7051: Dermatology
Contact Person Name
An Van Laethem
Contact Person Email
an.vanlaethem@uzleuven.be

Sponsor

Primary sponsor

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

Contract research organisations

Name
Syneos Health Inc.
Responsibilities
code:1
Name
PRA Hellas CRO A.E.
Responsibilities
code:1
Name
IQVIA Limited
Responsibilities
Randomization of patients; Management of drug, supply logistics, dispensing and unblinding; code:1
Name
Parexel International (IRL) Limited
Responsibilities
code:12
Name
Icon Clinical Research Limited
Responsibilities
code:1

Third parties

  • {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"Photography","organisation_type":"Pharmaceutical company"}
  • {"country":"Austria","full_name":"ABF Pharmaceutical Services GmbH","duties_or_roles":"Local depot for AxMP to sites/ final Rec. + Destruction","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"SGS France","duties_or_roles":"Pharmacokinetics (PK) analysis; code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Freezers and cooler bags supply","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Labor Dr. Spranger","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"code:4","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Freezers and cooler bags supply","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Kayentis","duties_or_roles":"PRO management, PRO licensing and translations, data collection via tablet; code:7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code:6; code:7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"code:13; Central ECG reading","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"PRO formatting and translations TFQ (trial feedback questionnaire) provider","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"code:12","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Convenience","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Subject Well Inc.","duties_or_roles":"Digital Patient recruitment","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Austria","full_name":"Mag. Andreas Raffeiner GmbH","duties_or_roles":"code:8","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited (duplicate entry for specific duties)","duties_or_roles":"Randomization of patients; Management of drug, supply logistics, dispensing and unblinding; code:3","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited (additional entry)","duties_or_roles":"code:15","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited (additional entry)","duties_or_roles":"Freezers and cooler bags supply","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
LOU064
Active Substance
REMIBRUTINIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus:1
Investigational Product Name
Placebo to remibrutinib (lou064) 0 mg matching 00 mg film-coated tablet
Modality
Other
Starting Dose
0 mg

Related trials

Other published trials that may interest you.