Clinical trial • Phase III • Neurology

Fenebrutinib for Primary progressive multiple sclerosis

Phase III trial of Fenebrutinib for Primary progressive multiple sclerosis.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Primary progressive multiple sclerosis
Trial Stage
Phase III
Drug Modality
Small molecule|Monoclonal antibody

Key dates

Initial CTIS Submission Date
19-07-2024
First CTIS Authorization Date
21-08-2024

Trial design

Randomised, fenebrutinib versus ocrelizumab (doses and schedules not specified in the record)-controlled Phase III trial across 58 sites in Poland, Spain, Portugal and others.

Randomised
Yes
Comparator
Fenebrutinib versus Ocrelizumab (doses and schedules not specified in the record)
Target Sample Size
688
Trial Duration For Participant
840

Eligibility

Recruits 688 Vulnerable population selected (isVulnerablePopulationSelected = true); specific consent/assent procedures are not detailed in the supplied record..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true); specific consent/assent procedures are not detailed in the supplied record.

Inclusion criteria

  • {"criterion_text":"-Ability to comply with the study protocol\n-A diagnosis of PPMS in accordance to the revised 2017 McDonald Criteria\n-Disability progression in the 12 months prior to screening, as assessed by the Pre-Baseline Disability Progression Questionnaire\n-EDSS score from 3.0 to 6.5 inclusive at screening\n-Pyramidal functional subscore ≥ 2 at screening\n-For patients currently receiving proton pump inhibitors (PPIs) or H2 receptor antagonists (H2RAs): treatment at a stable dose during the screening period prior to the initiation of study treatment and plans to remain at a stable dose for the duration of study treatment"}

Exclusion criteria

  • {"criterion_text":"-For patients enrolled in Germany and in Italy only: Presence of T1Gd + lesion on the screening MRI\n-Any known or suspected active infection at screening or baseline, (excluding onychomycosis) or any major episode of infection requiring hospitalization or treatment with IV antimicrobials within 8 weeks prior to and during screening or treatment with oral antimicrobials within 2 weeks prior to and during screening Onychomycosis is not exclusionary unless it is being treated with systemic therapy.\n-History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)\n-Patients with a previous history of a serious IRR and/or any hypersensitivity reaction to ocrelizumab\n-History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening\n-Immunocompromised state"}

Endpoints

Primary endpoints

  • {"endpoint_text":"-1. Time to onset of composite 12-week confirmed disability progression (cCDP12)","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"-1. Time to onset of composite 24 week CDP (cCDP24)","definition_or_measurement_approach":""}
  • {"endpoint_text":"-2. Time to onset of 12-week CDP (CDP12)","definition_or_measurement_approach":""}
  • {"endpoint_text":"-3. Time to onset of 24 week CDP (CDP24)","definition_or_measurement_approach":""}
  • {"endpoint_text":"-4. Percent change in total brain volume from Week 24 as assessed by MRI scan","definition_or_measurement_approach":"Assessed by MRI scan (percent change from Week 24)"}
  • {"endpoint_text":"-5. Percent change from screening to Week 120 in serum neurofilament light chain (NfL) levels","definition_or_measurement_approach":"Percent change in serum NfL from screening to Week 120"}
  • {"endpoint_text":"-6. Change patient-reported physical impacts of MS (as measured by Multiple Sclerosis Impact Scale, 29-Item [MSIS-29] physical scale)","definition_or_measurement_approach":"Measured by MSIS-29 physical scale"}
  • {"endpoint_text":"-7. Time to onset of 12 week confirmed 4 point worsening in Symbol Digit Modality Test (SDMT) score","definition_or_measurement_approach":"Time to confirmed 4-point worsening on SDMT at 12 weeks"}
  • {"endpoint_text":"-8. The nature, frequency, timing, and severity of adverse events; serious adverse events; and adverse events leading to study treatment withdrawal","definition_or_measurement_approach":"Standard collection and reporting of adverse events, serious adverse events, and withdrawals"}
  • {"endpoint_text":"-9. Change from baseline in targeted vital signs","definition_or_measurement_approach":""}
  • {"endpoint_text":"-10. Change from baseline in targeted ECG parameters","definition_or_measurement_approach":""}
  • {"endpoint_text":"-11. Change from baseline in clinical laboratory results following study treatment administration","definition_or_measurement_approach":""}
  • {"endpoint_text":"-12. Change from baseline in the proportion of patients with suicidal ideation or behavior, as assessed by Columbia Suicide Severity Rating Scale (C-SSRS)","definition_or_measurement_approach":"Assessed by Columbia Suicide Severity Rating Scale (C-SSRS)"}
  • {"endpoint_text":"-13. Plasma concentration of fenebrutinib at specified timepoints","definition_or_measurement_approach":"Plasma PK sampling at specified timepoints"}

Recruitment

Planned Sample Size
688
Recruitment Window Months
88
Consent Approach
Informed consent obtained from participants. Subject information and informed consent forms (SIS and ICF) are available in multiple languages (including English, German [de-de and de-at], Spanish, Italian, Portuguese, Greek, Hungarian, French, Polish, Bulgarian). Additional ICFs for pregnancy, pregnancy outcome/newborn, open-label extension, optional PK/genetic/stool sample collections and partner/infant forms are included in the document list. Specific age-based assent procedures or detailed consent handling steps are not described in the supplied record.

Methods

  • Publicis Healthcare Communications Group Limited — Patient recruitment (organisation listed as third party with role: Patient recruitment)
  • Innovative Trials Limited — Patient recruitment (organisation listed as third party with role: Patient recruitment)
  • WCG Clinical Inc. — Patient recruitment (organisation listed as third party with role: Patient recruitment)
  • Medical Research Network Limited — Mobile Nursing (organisation listed as third party with role: Mobile Nursing)
  • Axon Communications Inc. — Patient recruitment; Investigator Communications / Portal
  • Greenphire LLC — Patient reimbursement
  • Eresearchtechnology Inc. (Clario) — eCOA (electronic clinical outcome assessments)
  • Iqvia Inc. — Monitoring
  • Various laboratory service providers (Azenta Germany GmbH; Labcorp; Labcorp Early Development Laboratories Inc.; Eurofins Viracor; Frontage Laboratories Inc.; Labcorp Central Laboratory Services LP) for sample handling/analysis

Geography

Total Number Of Sites
58
Total Number Of Participants
297

Poland

Earliest CTIS Part Ii Submission Date
12-08-2024
Latest Decision Or Authorization Date
02-09-2024
Processing Time Days
21
Number Of Sites
10
Number Of Participants
64

Sites

Site Name
Med Polonia Sp. z o.o.
Principal Investigator Name
Karolina Piasecka-Stryczyńska
Principal Investigator Email
badania.kliniczne@medpolonia.pl
Contact Person Name
Karolina Piasecka-Stryczyńska
Site Name
Centrum Neurologii Krzysztof Selmaj
Principal Investigator Name
Krzysztof Selmaj
Principal Investigator Email
centrum.neurologii.k.selmaj@gmail.com
Contact Person Name
Krzysztof Selmaj
Site Name
Care Clinic Sp. z o.o.
Department Name
Poradnia neurologiczna
Principal Investigator Name
Ewa Krzystanek
Principal Investigator Email
poczta@careclinic.katowice.pl
Contact Person Name
Ewa Krzystanek
Contact Person Email
poczta@careclinic.katowice.pl
Site Name
Wromedica I Bielicka A Strzalkowska s.c.
Principal Investigator Name
Bartłomiej Mielcarek
Principal Investigator Email
biuro@wromedica.pl
Contact Person Name
Bartłomiej Mielcarek
Contact Person Email
biuro@wromedica.pl
Site Name
Centrum Medyczne Neuroprotect
Principal Investigator Name
Maciej Czarnecki
Principal Investigator Email
recepcja@neuroprotect.pl
Contact Person Name
Maciej Czarnecki
Contact Person Email
recepcja@neuroprotect.pl
Site Name
Nmedis Sp. z o.o.
Principal Investigator Name
Iwona Rościszewska-Żukowska
Principal Investigator Email
badaniakliniczne@nmedis.pl
Contact Person Name
Iwona Rościszewska-Żukowska
Contact Person Email
badaniakliniczne@nmedis.pl
Site Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
Department Name
Oddział Neurologiczny
Principal Investigator Name
Monika Adamczyk-Sowa
Principal Investigator Email
neurozab@sum.edu.pl
Contact Person Name
Monika Adamczyk-Sowa
Contact Person Email
neurozab@sum.edu.pl
Site Name
Centrum Medyczne Medyk Sp. z o.o.
Department Name
Poradnia neurologiczna
Principal Investigator Name
Halina Bartosik-Psujek
Principal Investigator Email
medyk@medyk.rzeszow.pl
Contact Person Name
Halina Bartosik-Psujek
Contact Person Email
medyk@medyk.rzeszow.pl
Site Name
Neuro-Care Sp. z o.o. sp.k.
Department Name
Poradnia Neurologiczna
Principal Investigator Name
Gabriela Kłodowska
Principal Investigator Email
neuro-care@neuro-care.pl
Contact Person Name
Gabriela Kłodowska
Contact Person Email
neuro-care@neuro-care.pl
Site Name
Neurocentrum Bydgoszcz Sp. z o.o.
Principal Investigator Name
Robert Bonek
Principal Investigator Email
rejestracja@ncbydgoszcz.pl
Contact Person Name
Robert Bonek
Contact Person Email
rejestracja@ncbydgoszcz.pl

Spain

Earliest CTIS Part Ii Submission Date
12-08-2024
Latest Decision Or Authorization Date
06-09-2024
Processing Time Days
25
Number Of Sites
9
Number Of Participants
51

Sites

Site Name
Hospital Universitario Puerta Del Mar
Department Name
Neurología
Principal Investigator Name
Raúl Espinosa Rosso
Principal Investigator Email
r.espinosarosso@hotmail.es
Contact Person Name
Raúl Espinosa Rosso
Contact Person Email
r.espinosarosso@hotmail.es
Site Name
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Department Name
Neurología
Principal Investigator Name
Luis Brieva Ruiz
Principal Investigator Email
brievaluis@hotmail.com
Contact Person Name
Luis Brieva Ruiz
Contact Person Email
brievaluis@hotmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Neurología
Principal Investigator Name
Xavier Montalbán Gairín
Principal Investigator Email
xavier.montalban@cem-cat.org
Contact Person Name
Xavier Montalbán Gairín
Contact Person Email
xavier.montalban@cem-cat.org
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Neurología
Principal Investigator Name
Rafael Arroyo González
Principal Investigator Email
rafaelarroyo09@gmail.com
Contact Person Name
Rafael Arroyo González
Contact Person Email
rafaelarroyo09@gmail.com
Site Name
Hospital Universitario Regional De Malaga
Department Name
Neurología
Principal Investigator Name
Ana Alonso Torres
Principal Investigator Email
a.alonso.eecc@gmail.com
Contact Person Name
Ana Alonso Torres
Contact Person Email
a.alonso.eecc@gmail.com
Site Name
Hospital Alvaro Cunqueiro
Department Name
Neurología
Principal Investigator Name
Inés González Suárez
Principal Investigator Email
Ines.Maria.Gonzalez.Suarez@sergas.es
Contact Person Name
Inés González Suárez
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Neurología
Principal Investigator Name
Ana López Real
Principal Investigator Email
Ana.maria.Lopez.Real@sergas.es
Contact Person Name
Ana López Real
Contact Person Email
Ana.maria.Lopez.Real@sergas.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Neurología
Principal Investigator Name
Lucienne Costa-Frossard
Principal Investigator Email
lufrossard@yahoo.es
Contact Person Name
Lucienne Costa-Frossard
Contact Person Email
lufrossard@yahoo.es
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Neurología
Principal Investigator Name
Sara Eichau Madueño
Principal Investigator Email
saraeichau@gmail.com
Contact Person Name
Sara Eichau Madueño
Contact Person Email
saraeichau@gmail.com

Portugal

Earliest CTIS Part Ii Submission Date
12-08-2024
Latest Decision Or Authorization Date
21-08-2024
Processing Time Days
9
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Serviço de Neurologia
Principal Investigator Name
João Cerqueira
Principal Investigator Email
2ca@ccabraga.org
Contact Person Name
João Cerqueira
Contact Person Email
2ca@ccabraga.org
Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Serviço de Neurologia
Principal Investigator Name
Ernestina Santos
Contact Person Name
Ernestina Santos
Site Name
Unidade Local De Saude De Sao Jose E.P.E.
Department Name
Serviço de Neurologia
Principal Investigator Name
João Sequeira
Principal Investigator Email
ensaiosclinicos@chlc.min-saude.pt
Contact Person Name
João Sequeira
Site Name
Unidade Local de Saude de Sao Joao E.P.E.
Department Name
Serviço de Neurologia
Principal Investigator Name
Ricardo Reis
Principal Investigator Email
centro.investigacao@chsj.min-saude.pt
Contact Person Name
Ricardo Reis
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Serviço de Neurologia
Principal Investigator Name
João Ferreira
Principal Investigator Email
jnuno.d.ferreira@gmail.com
Contact Person Name
João Ferreira
Contact Person Email
jnuno.d.ferreira@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
12-08-2024
Latest Decision Or Authorization Date
27-08-2024
Processing Time Days
15
Number Of Sites
7
Number Of Participants
15

Sites

Site Name
Ospedale San Raffaele S.r.l.
Department Name
Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla
Principal Investigator Name
Massimo Filippi
Principal Investigator Email
filippi.massimo@hsr.it
Contact Person Name
Massimo Filippi
Contact Person Email
filippi.massimo@hsr.it
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
U.O.S.D. Sclerosi Multipla
Principal Investigator Name
Girolama Alessandra Marfia
Principal Investigator Email
marfia@uniroma2.it
Contact Person Name
Girolama Alessandra Marfia
Contact Person Email
marfia@uniroma2.it
Site Name
Azienda Ospedaliera Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
U.O.C. I Neurologia, DAI Medicina Interna, Geriatria e Neurologia
Principal Investigator Name
Antonio Gallo
Principal Investigator Email
antonio.gallo@unicampania.it
Contact Person Name
Antonio Gallo
Contact Person Email
antonio.gallo@unicampania.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
S.S.D. Neurologia
Principal Investigator Name
Cinzia Cordioli
Principal Investigator Email
centrosmbs@gmail.com
Contact Person Name
Cinzia Cordioli
Contact Person Email
centrosmbs@gmail.com
Site Name
Istituto Neurologico Mediterraneo Neuromed S.p.A.
Department Name
Neurologia
Principal Investigator Name
Diego Centonze
Principal Investigator Email
centonze@uniroma2.it
Contact Person Name
Diego Centonze
Contact Person Email
centonze@uniroma2.it
Site Name
ARNAS Civico Di Cristina Benfratelli
Department Name
U.O.C. Neurologia con Stroke Unit
Principal Investigator Name
Salvatore Cottone
Principal Investigator Email
salvatore.cottone1@arnascivico.it
Contact Person Name
Salvatore Cottone
Site Name
Azienda Ospedaliero Universitaria Parma
Department Name
S.C. Neurologia
Principal Investigator Name
Erica Curti
Principal Investigator Email
ecurti@ao.pr.it
Contact Person Name
Erica Curti
Contact Person Email
ecurti@ao.pr.it

Hungary

Earliest CTIS Part Ii Submission Date
12-08-2024
Latest Decision Or Authorization Date
27-08-2024
Processing Time Days
15
Number Of Sites
5
Number Of Participants
11

Sites

Site Name
Clinexpert Kft.
Department Name
-
Principal Investigator Name
Istvan Kapas
Principal Investigator Email
istvan.kapas00@gmail.com
Contact Person Name
Istvan Kapas
Contact Person Email
istvan.kapas00@gmail.com
Site Name
S-Medicon Kft.
Department Name
Neurologia
Principal Investigator Name
Maria Satori
Principal Investigator Email
satori.maria@gmail.com
Contact Person Name
Maria Satori
Contact Person Email
satori.maria@gmail.com
Site Name
Kistarcsai Flor Ferenc Korhaz
Department Name
-
Principal Investigator Name
Zita Biro
Principal Investigator Email
birozitamaria@gmail.com
Contact Person Name
Zita Biro
Contact Person Email
birozitamaria@gmail.com
Site Name
Heves Varmegyei Markhot Ferenc Oktatokorhaz Es Rendelointezet
Department Name
Neurologiai es Stroke Osztaly
Principal Investigator Name
Attila Balazs
Principal Investigator Email
kriszdok2@freemail.hu
Contact Person Name
Attila Balazs
Contact Person Email
kriszdok2@freemail.hu
Site Name
Jahn Ferenc Del-Pesti Korhaz Es Rendelointezet
Department Name
Neurologiai Osztaly
Principal Investigator Name
Csilla Rozsa
Principal Investigator Email
rozsa.csilla@delpestikorhaz.hu
Contact Person Name
Csilla Rozsa
Contact Person Email
rozsa.csilla@delpestikorhaz.hu

Greece

Earliest CTIS Part Ii Submission Date
12-08-2024
Latest Decision Or Authorization Date
22-08-2024
Processing Time Days
10
Number Of Sites
3
Number Of Participants
16

Sites

Site Name
401 General Military Hospital Of Athens
Department Name
Neurology Clinic
Principal Investigator Name
Fakas Nikolaos
Principal Investigator Email
drfakas@yahoo.gr
Contact Person Name
Fakas Nikolaos
Contact Person Email
drfakas@yahoo.gr
Site Name
Eginitio Hospital
Department Name
A’ Neurology Clinic
Principal Investigator Name
Leonidas Stefanis
Principal Investigator Email
lstefanis@bioacademy.gr
Contact Person Name
Leonidas Stefanis
Contact Person Email
lstefanis@bioacademy.gr
Site Name
University General Hospital Of Thessaloniki Ahepa
Department Name
B’ Neurology Clinic
Principal Investigator Name
Nikolaos Grigoriadis
Principal Investigator Email
ngrigoriadis@auth.gr
Contact Person Name
Nikolaos Grigoriadis
Contact Person Email
ngrigoriadis@auth.gr

Germany

Earliest CTIS Part Ii Submission Date
12-08-2024
Latest Decision Or Authorization Date
22-08-2024
Processing Time Days
10
Number Of Sites
7
Number Of Participants
23

Sites

Site Name
Medical Center - University Of Freiburg
Department Name
Neurologie und Neurophysiologie
Principal Investigator Name
Sebastian Rauer
Principal Investigator Email
neurologie@uniklinik-freiburg.de
Contact Person Name
Sebastian Rauer
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
Klinik für Neurologie
Principal Investigator Name
Achim Berthele
Principal Investigator Email
Achim.Berthele@mri.tum.de
Contact Person Name
Achim Berthele
Contact Person Email
Achim.Berthele@mri.tum.de
Site Name
DKD HELIOS Klinik Wiesbaden GmbH
Department Name
Neurologie
Principal Investigator Name
Matthias Wahl
Principal Investigator Email
mathias.wahl@helios-gesundheit.de
Contact Person Name
Matthias Wahl
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Klinische Neurowissenschaften
Principal Investigator Name
Tjalf Ziemssen
Principal Investigator Email
tjalf.ziemssen@uniklinikum-dresden.de
Contact Person Name
Tjalf Ziemssen
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Neurologie
Principal Investigator Name
Carolin Otto
Principal Investigator Email
carolin.otto@charite.de
Contact Person Name
Carolin Otto
Contact Person Email
carolin.otto@charite.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Zentrum für Neurologie
Principal Investigator Name
Ulf Ziemann
Principal Investigator Email
ulf.ziemann@med.uni-tuebingen.de
Contact Person Name
Ulf Ziemann
Site Name
Studienzentrum Dr. Bischof GmbH
Department Name
Neurologie und Psychiatrie
Principal Investigator Name
Felix Bischof
Principal Investigator Email
info@bischof-secheres.de
Contact Person Name
Felix Bischof
Contact Person Email
info@bischof-secheres.de

France

Earliest CTIS Part Ii Submission Date
30-08-2024
Latest Decision Or Authorization Date
09-09-2024
Processing Time Days
10
Number Of Sites
6
Number Of Participants
77

Sites

Site Name
Hospital Pierre Wertheimer
Department Name
Neurologie
Principal Investigator Name
Sandra Vukusic
Principal Investigator Email
sandra.vukusic@chu-lyon.fr
Contact Person Name
Sandra Vukusic
Contact Person Email
sandra.vukusic@chu-lyon.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Neurologie
Principal Investigator Name
Jérôme De Seze
Principal Investigator Email
jerome.de.seze@chru-strasbourg.fr
Contact Person Name
Jérôme De Seze
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Service de neurologie
Principal Investigator Name
Christine Lebrun Frenay
Principal Investigator Email
lebrun-frenay.c@chu-nice.fr
Contact Person Name
Christine Lebrun Frenay
Contact Person Email
lebrun-frenay.c@chu-nice.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Neurologie
Principal Investigator Name
David Laplaud
Principal Investigator Email
david.laplaud@chu-nantes.fr
Contact Person Name
David Laplaud
Contact Person Email
david.laplaud@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Neurologie
Principal Investigator Name
Pierre Labauge
Principal Investigator Email
p-labauge@chu-montpellier.fr
Contact Person Name
Pierre Labauge
Contact Person Email
p-labauge@chu-montpellier.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Neurologie
Principal Investigator Name
Aurélie Ruet
Principal Investigator Email
aurelie.ruet@chu-bordeaux.fr
Contact Person Name
Aurélie Ruet
Contact Person Email
aurelie.ruet@chu-bordeaux.fr

Denmark

Earliest CTIS Part Ii Submission Date
12-08-2024
Latest Decision Or Authorization Date
22-08-2024
Processing Time Days
10
Number Of Sites
2
Number Of Participants
7

Sites

Site Name
Rigshospitalet
Department Name
Neurologisk Klinik
Principal Investigator Name
Jette Frederiksen Battistini
Principal Investigator Email
jette.lautrup.battistini@regionh.dk
Contact Person Name
Jette Frederiksen Battistini
Site Name
Aarhus Universitetshospital
Department Name
Neurologisk Afdeling F, Skleroseklinikken
Principal Investigator Name
Kristina Bacher Svendsen
Principal Investigator Email
krissven@rm.dk
Contact Person Name
Kristina Bacher Svendsen
Contact Person Email
krissven@rm.dk

Austria

Earliest CTIS Part Ii Submission Date
12-08-2024
Latest Decision Or Authorization Date
26-08-2024
Processing Time Days
14
Number Of Sites
2
Number Of Participants
16

Sites

Site Name
Medical University Of Vienna
Department Name
Department of Neurology
Principal Investigator Name
Fritz Leutmezer
Principal Investigator Email
neurostudien@meduniwien.ac.at
Contact Person Name
Fritz Leutmezer
Contact Person Email
neurostudien@meduniwien.ac.at
Site Name
Kepler Universitaetsklinikum GmbH
Department Name
University Clinic for Neurology
Principal Investigator Name
Hamid Assar
Principal Investigator Email
hamid.assar@kepleruniklinikum.at
Contact Person Name
Hamid Assar

Bulgaria

Earliest CTIS Part Ii Submission Date
12-08-2024
Latest Decision Or Authorization Date
13-09-2024
Processing Time Days
32
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Department Name
Neurology clinic
Principal Investigator Name
Maya Danovska-Mladenova
Principal Investigator Email
mdanovska@yahoo.com
Contact Person Name
Maya Danovska-Mladenova
Contact Person Email
mdanovska@yahoo.com
Site Name
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
Department Name
Department of Movement Disorders, Multiple Sclerosis
Principal Investigator Name
Ivan Milanov
Principal Investigator Email
ubalnp@yahoo.com
Contact Person Name
Ivan Milanov
Contact Person Email
ubalnp@yahoo.com

Sponsor

Primary sponsor

Full Name
F. Hoffmann-La Roche AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
Iqvia Inc.
Responsibilities
Monitoring
Name
Labcorp
Responsibilities
Laboratory services / sample analysis (role indicated; specific responsibilities not detailed)
Name
Labcorp Early Development Laboratories Inc.
Responsibilities
Laboratory services (role code present; specific responsibilities not detailed)
Name
Frontage Laboratories Inc.
Responsibilities
Laboratory services (role code present; specific responsibilities not detailed)
Name
Eurofins Viracor Biopharma Services Inc.
Responsibilities
Laboratory services (role code present; specific responsibilities not detailed)
Name
Almac Clinical Services LLC
Responsibilities
Clinical services (role code present; specific responsibilities not detailed)

Third parties

  • {"country":"United Kingdom","full_name":"Publicis Healthcare Communications Group Limited","duties_or_roles":"Patient recruitment","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Medical Research Network Limited","duties_or_roles":"Mobile Nursing","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Axon Communications Inc.","duties_or_roles":"Patient recruitment, Investigator Communications / Portal","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"University Of California San Francisco","duties_or_roles":"","organisation_type":"Educational Institution"}
  • {"country":"Switzerland","full_name":"Eviden (ATOS)","duties_or_roles":"Non-IMP Materials Provider","organisation_type":"Health care"}
  • {"country":"United Kingdom","full_name":"Innovative Trials Limited","duties_or_roles":"Patient recruitment","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"Monitoring","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Canada","full_name":"Neurorx Research Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Neurostatus-UHB AG","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Patient recruitment","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":"Frontage Laboratories Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q2q Communications Limited","duties_or_roles":"Meeting organizer","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
Fenebrutinib
Active Substance
Fenebrutinib
Modality
Small molecule
Authorisation Status
prodAuthStatus: 1 (as recorded in productDictionaryInfo)
Investigational Product Name
Ocrelizumab
Active Substance
Ocrelizumab
Modality
Monoclonal antibody
Authorisation Status
Marketing authorisation present (marketingAuthNumber: EU/1/17/1231/002 and EU/1/17/1231/001; prodAuthStatus: 2 as recorded)
Investigational Product Name
Placebo (fenebrutinib comparator)
Modality
Other
Investigational Product Name
Placebo (ocrelizumab comparator)
Modality
Other

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