Clinical trial • Phase III • Neurology

CLADRIBINE for Generalized Myasthenia Gravis

Phase III trial of CLADRIBINE for Generalized Myasthenia Gravis.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Generalized Myasthenia Gravis
Trial Stage
Phase III
Drug Modality
Small molecule|Vaccine

Key dates

Initial CTIS Submission Date
29-04-2024
First CTIS Authorization Date
09-10-2024

Trial design

Randomised, placebo (oral), administered as placebo matched to cladribine, orally as 2 separate treatment courses starting on day 1 and at the beginning of week 5. active comparator arms: cladribine high dose (oral) — administered as 2 separate treatment courses starting on day 1 and at the beginning of week 5; cladribine low dose (oral) — administered as 2 separate treatment courses starting on day 1 and at the beginning of week 5. (no numeric dose levels provided in part i documentation.)-controlled, adaptive Phase III trial in Czechia, Poland, Romania and others.

Randomised
Yes
Comparator
Placebo (oral), administered as placebo matched to Cladribine, orally as 2 separate treatment courses starting on Day 1 and at the beginning of Week 5. Active comparator arms: Cladribine High Dose (oral) — administered as 2 separate treatment courses starting on Day 1 and at the beginning of Week 5; Cladribine Low Dose (oral) — administered as 2 separate treatment courses starting on Day 1 and at the beginning of Week 5. (No numeric dose levels provided in Part I documentation.)
Adaptive
True — an independent statistical data analysis center is designated to perform an interim analysis and report results to an External Data Monitoring Committee; the study includes blinded extension and retreatment periods and retreatment rules contingent on clinical justification.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
196

Eligibility

Recruits 196 The study flag indicates vulnerable populations selected (isVulnerablePopulationSelected: true). Country-specific consideration: "Applicable for France only: Persons under court protection, persons not affiliated to a social security system, protected adults." Informed consent is handled via participant ICFs and eConsent (Medable) with language-specific ICFs and supporting materials; a Pregnant Partner ICF is provided. Assent for minors is not mentioned in the documentation..

Vulnerable Population
The study flag indicates vulnerable populations selected (isVulnerablePopulationSelected: true). Country-specific consideration: "Applicable for France only: Persons under court protection, persons not affiliated to a social security system, protected adults." Informed consent is handled via participant ICFs and eConsent (Medable) with language-specific ICFs and supporting materials; a Pregnant Partner ICF is provided. Assent for minors is not mentioned in the documentation.

Inclusion criteria

  • {"criterion_text":"- \"Diagnosis of Myasthenia Gravis with generalized muscle weakness, meeting clinical criteria for Myasthenia Gravis Foundation of America Class II to IVa classification. - In participants positive for Acetylcholine receptor antibody (anti-AChR) or muscle-specific kinase antibody (anti-MuSK) - In participants that are autoantibody seronegative and participants who are positive for anti-low-density lipoprotein receptor-related protein 4 antibodies (anti-LRP4) \"\n- Has a Screening and Baseline MG-ADL score more than or equal to (>=) 6 with at least 50 percent (%) of the total score due to non-ocular symptoms. Screening and Baseline MG-ADL scores must be stable. The difference between the screening and Baseline scores should not be more than 2 and there should be no reported MG exacerbation during the screening period.\n- If treated with oral corticosteroids: should be on a stable daily dose for at least 3 months prior to and during screening. In such case, the daily dose of oral steroids should not exceed 20 milligrams(mg)/day for prednisone/prednisolone or 16 mg/day for methylprednisolone.\n- If treated with acetylcholinesterase inhibitor should be on a stable daily dose for at least 3 months prior and during screening..\n- Have a body weight >= 40 kilograms.\n- Other protocol defined inclusion criteria could apply."}

Exclusion criteria

  • {"criterion_text":"- Immunologic disorder other than MG or any other condition requiring chronic oral, intravenous, intramuscular, or intraarticular corticosteroid therapy. Well-controlled thyroid disease, as per the Treating Investigator or the participants regular treating physician recorded in the source documents, is not exclusionary.\n- Active malignancy, or history of cancer.\n- Treatment with nonsteroidal immunosuppressants, used in gMG, such as azathioprine, mycophenolate mofetil, methotrexate, cyclosporine, tacrolimus within 4 weeks prior to randomization.\n- History of generalized seizures (except for history of febrile seizures during the participant’s childhood)\n- History of recurrent infections (that is 3 or more infections per year) within the last 2 years\n- Discontinuation of treatment with any non-steroidal immunosuppressants used in gMG, such as azathioprine, mycophenolate mofetil, methotrexate, cyclosporine, tacrolimus within the last 6 months prior to Screening\n- If treated with non-steroidal immunosuppressants for gMG, the dose at Screening should not exceed 50 mg/day for azathioprine, 500 mg/day for mycophenolate mofetil, 1 mg/day for tacrolimus, 50 mg/day for cyclosporine, or 7.5 mg/week for methotrexate\n- Participation in clinical study of any investigational drug within 6 months, or 5 half-lives of the investigational drug used in the previous clinical study prior to randomization, whichever is longer. However, participants with any prior exposure to cladribine may not enter the study regardless of timing of exposure\n- Treatment with eculizumab, rozanolixizumab efgartigimod, ravulizumab, or zilucoplan within 8 weeks prior to randomization\n- History of thymectomy within 6 months prior to Screening.\n- History of myasthenic crisis in the last 12 months prior to and during screening\n- Applicable for France only: Persons under court protection, persons not affiliated to a social security system, protected adults.\n- Negative for Varicella Zoster Virus antibodies at screening.\n- Other protocol defined exclusion criteria could apply.\n- Molecularly characterized or suspected congenital myasthenic syndrome, Lambert-Eaton myasthenic syndrome, inherited myopathy, muscular dystrophy, acquired myopathy or any other neurologic or systematic disease that mimics MG muscular weakness.\n- Active, clinically significant viral, bacterial, or fungal infection, including brain MRI findings consistent with signs of infection such as PML, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 8 weeks prior or during Screening, or completion of oral anti-infectives within 8 weeks prior or during Screening, or a history of recurrent infections. Vaginal candidiasis, onychomycosis, and genital or oral herpes simplex virus considered by the Investigator to be sufficiently controlled would not be exclusionary.\n- Has a history of or current diagnosis of active tuberculosis (TB)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change from Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Scale Score at Week 24 During the Double-Blind Placebo Controlled (DBPC) Period.","definition_or_measurement_approach":"Change from baseline in MG-ADL score measured at Week 24 during the double-blind placebo-controlled period."}

Secondary endpoints

  • {"endpoint_text":"- Change from Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score at Week 24 during the Double-Blind Placebo Controlled (DBPC) Period.","definition_or_measurement_approach":"Change from baseline in QMG score measured at Week 24 during the DBPC period."}
  • {"endpoint_text":"- Percentage of MG-ADL Responders at Week 24 during the Double-Blind Placebo Controlled (DBPC) Period.","definition_or_measurement_approach":"Proportion of participants meeting pre-specified responder criteria on the MG-ADL at Week 24 during the DBPC period."}
  • {"endpoint_text":"- Change from Baseline in Myasthenia Gravis Composite (MGC) Scale Score at Week 24 during the Double-Blind Placebo Controlled (DBPC) Period.","definition_or_measurement_approach":"Change from baseline in MGC score measured at Week 24 during the DBPC period."}
  • {"endpoint_text":"- Percentage of Quantitative Myasthenia Gravis (QMG) Scale Responders at Week 24 during the Double-Blind Placebo Controlled (DBPC) Period.","definition_or_measurement_approach":"Proportion of participants meeting pre-specified responder criteria on the QMG at Week 24 during the DBPC period."}
  • {"endpoint_text":"- Change from Baseline in the Revised Myasthenia Gravis Quality of Life – 15 Scale (MG-Qol15r) Score at Week 24 during the Double-Blind Placebo Controlled (DBPC) Period.","definition_or_measurement_approach":"Change from baseline in MG-QoL15r score measured at Week 24 during the DBPC period."}
  • {"endpoint_text":"- Time From Initial Cladribine Full Dose Treatment to First Retreatment of Rescue Treatment up to end of Study.","definition_or_measurement_approach":"Time-to-event: time from initial full-dose cladribine to first retreatment or rescue treatment up to study end."}
  • {"endpoint_text":"- Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs).","definition_or_measurement_approach":"Count and categorisation of AEs and AESIs per standard safety reporting."}
  • {"endpoint_text":"- Number of participants with Adverse Events (AEs) by Severity as per National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.","definition_or_measurement_approach":"AE severity graded by NCI CTCAE v5.0 and reported as counts by grade."}
  • {"endpoint_text":"- Number of Participants with Abnormal Laboratory Variables including Absolute Lymphocyte Count and Vital Signs.","definition_or_measurement_approach":"Number of participants with abnormalities in laboratory parameters (including absolute lymphocyte count) and vital signs per predefined criteria."}
  • {"endpoint_text":"- Pharmacokinetic (PK) Plasma Concentrations of Cladribine.","definition_or_measurement_approach":"Measurement of cladribine plasma concentrations (PK) in specified sampling (rich PK sampling group) and analysis of PK parameters."}

Recruitment

Registry Or Advocacy Recruitment
True, organisations named with explicit 'Patient recruitment and advisory' duties include: Unisphere Travel Ltd. Inc.; Inato.
Digital Remote Recruitment
True — methods include web banner digital advertising, digital PAG banner ads, patient informational website content, eConsent (Medable eConsent, eIDAS compatibility resources), televisit instructions, patient app (eCOA/ePRO), and digital recruitment hub content (country-specific).
Planned Sample Size
196
Recruitment Window Months
68
Consent Approach
Informed consent is conducted via subject information sheets and informed consent forms (ICFs) with eConsent supported (Medable) and eIDAS compatibility resources. Multiple language ICFs and supporting materials are provided (examples include English, Polish, Czech, French, Spanish, Italian, German, Bulgarian, Romanian, Hungarian, Swedish, Dutch, Greek). A specific Pregnant Partner ICF is available. Televisit and eConsent instructional materials and Medable support numbers are provided. Assent for minors is not mentioned.

Methods

  • Dr-to-Patient Letter (physician referral letters) — country-specific versions (e.g., EN, PL, RO, GR, IT, DE, FR, NL etc.).
  • Patient flyer and patient poster — country-specific versions (examples present for PL, RO, GR, IT, DE, FR, ES, BG, HU, SE, CZ).
  • Web banners / Digital advertising (including Digital PAG Banner Ads and web banner assets) — country-specific versions.
  • Patient informational website content / Patient informational website — country-specific content provided.
  • Referral Hub content (e.g., 'Referral Hub content_IT') for clinician referrals.
  • Patient Study Guide / Take-home information leaflets; Patient Emergency Card.
  • Video materials (on-screen text and voice-over scripts) for recruitment outreach.
  • Patient app and eCOA/ePRO communications (Medable, eConsent resources) including instructions on eConsent and televisit materials.
  • Recruitment partners / patient recruitment vendors (documents reference patient recruitment and advisory responsibilities).

Geography

Total Number Of Sites
60
Total Number Of Participants
69

Czechia

Earliest CTIS Part Ii Submission Date
01-02-2025
Latest Decision Or Authorization Date
26-02-2025
Processing Time Days
25
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Neurology
Contact Person Name
Michaela Tyblova
Contact Person Email
michaela.tyblova@vfn.cz

Poland

Earliest CTIS Part Ii Submission Date
16-10-2024
Latest Decision Or Authorization Date
18-11-2024
Processing Time Days
33
Number Of Sites
5
Number Of Participants
5

Sites

Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Neurologii Dorosłych
Contact Person Name
Małgorzata Bilińska
Contact Person Email
malbili@gumed.edu.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Zespół Poradni Specjalistycznych - Botaniczna 3 Poradnia Neurologiczna
Contact Person Name
Agnieszka Słowik
Contact Person Email
neurologiabk@su.krakow.pl
Site Name
Mtz Clinical Research Powered By Pratia
Contact Person Name
Małgorzata Zajda
Contact Person Email
mzajda@pratia.pl
Site Name
Krakowska Akademia Neurologii Sp. z o.o.
Department Name
Centrum Neurologii Klinicznej
Contact Person Name
Andrzej Szczudlik
Site Name
Wielospecjalistyczne Centrum Medyczne IBISMED S.C
Contact Person Name
Monika Adamczyk-Sowa
Contact Person Email
cm@ibismed.pl

Romania

Earliest CTIS Part Ii Submission Date
30-01-2025
Latest Decision Or Authorization Date
03-03-2025
Processing Time Days
32
Number Of Sites
5
Number Of Participants
5

Sites

Site Name
Brainaxy Clinic S.R.L.
Department Name
Neurology
Contact Person Name
Any Axelerad
Contact Person Email
docuaxi@yahoo.com
Site Name
Institutul Clinic Fundeni
Department Name
Neurology
Contact Person Name
Crisanda Vilciu
Contact Person Email
crisandavalciu@yahoo.com
Site Name
Spitalul Clinic Judetean De Urgenta Targu Mures
Department Name
Neurology
Contact Person Name
Rodica Ioana Balasa
Contact Person Email
rodica.balasa@umfst.ro
Site Name
Neurocity Cercetare S.R.L.
Department Name
Neurology
Contact Person Name
Dan-Andrei Mitrea
Contact Person Email
dan.mitrea@neuroaxis.ro
Site Name
Aria Clinic S.R.L.
Department Name
Neurology
Contact Person Name
Cosmin Mutu
Contact Person Email
cosminmutu@yahoo.com

Greece

Earliest CTIS Part Ii Submission Date
11-10-2024
Latest Decision Or Authorization Date
25-02-2025
Processing Time Days
137
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
University General Hospital Of Thessaloniki Ahepa
Department Name
1st Department of Neurology
Contact Person Name
Vasileios Kimiskidis
Contact Person Email
kimiskid@auth.gr
Site Name
General University Hospital Of Larissa
Department Name
Neurology Clinic
Contact Person Name
Efthymios Dardiotis
Contact Person Email
edar@med.uth.gr
Site Name
General University Hospital Of Patras
Department Name
Neurology Clinic
Contact Person Name
Elisabeth Chroni
Contact Person Email
echroni@upatras.gr

Bulgaria

Earliest CTIS Part Ii Submission Date
30-01-2025
Latest Decision Or Authorization Date
27-03-2025
Processing Time Days
56
Number Of Sites
5
Number Of Participants
6

Sites

Site Name
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
Department Name
Clinic of neurology diseases
Contact Person Name
Mariya Dimitrova
Contact Person Email
dr.m.i.dimitrova@gmail.com
Site Name
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Department Name
Clinic of Neurology diseases
Contact Person Name
Georgi Slavov
Contact Person Email
georgi.slavov.15130@gmail.com
Site Name
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
Department Name
Clinic of neurodegenerative and peripheral nerve diseases
Contact Person Name
Ivan Milanov
Contact Person Email
prof.ivan.milanov@gmail.com
Site Name
Medical Center Hera EOOD
Department Name
Medical center Hera – branch Montana
Contact Person Name
Plamen Pelov
Contact Person Email
drpelov@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Department Name
Neurology Clinic
Contact Person Name
Maya Danovska-Mladenova
Contact Person Email
mdanovska@yahoo.com

Belgium

Earliest CTIS Part Ii Submission Date
28-01-2025
Latest Decision Or Authorization Date
07-02-2025
Processing Time Days
10
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
UZ Leuven
Department Name
Neurology
Contact Person Name
Kristl Claeys
Contact Person Email
kristl.Claeys@uzleuven.be
Site Name
Centre Hospitalier Regional De La Citadelle
Department Name
Neurology
Contact Person Name
Stéphanie Delstanche

Spain

Earliest CTIS Part Ii Submission Date
16-10-2024
Latest Decision Or Authorization Date
09-12-2024
Processing Time Days
54
Number Of Sites
6
Number Of Participants
10

Sites

Site Name
Hospital Germans Trias I Pujol
Department Name
Neurology
Contact Person Name
Sebastian Figueroa Bonaparte
Site Name
Hospital Universitario Regional De Malaga
Department Name
Neurology
Contact Person Name
Guillermina García
Contact Person Email
guille.garcia.eecc@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Neurology
Contact Person Name
Raul Juntas Morales
Contact Person Email
raul.juntas@vallhebron.cat
Site Name
Hospital Universitario Reina Sofia
Department Name
Neurology
Contact Person Name
Eduardo Agüera Morales
Contact Person Email
doctoredu@gmail.com
Site Name
Hospital Universitario Central De Asturias
Department Name
Neurology
Contact Person Name
German Moris de la Tassa
Contact Person Email
gmorist@gmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Neurology
Contact Person Name
Teresa Sevilla Mantecon
Contact Person Email
m.teresa.sevilla@uv.es

Italy

Earliest CTIS Part Ii Submission Date
23-04-2024
Latest Decision Or Authorization Date
16-01-2025
Processing Time Days
268
Number Of Sites
8
Number Of Participants
14

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Neurology
Contact Person Name
Raffaele Iorio
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
Neurology
Contact Person Name
Roberto Massa
Contact Person Email
massa@uniroma2.it
Site Name
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
Department Name
Neuroncology and Neuroinflammation
Contact Person Name
Matteo Gastaldi
Contact Person Email
matteo.gastaldi@mondino.it
Site Name
IRCCS Foundation Istituto Neurologico Carlo Besta
Department Name
Neuroimmunology and Muscle Pathology
Contact Person Name
Carlo Antozzi
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Neurology
Contact Person Name
Martina Garnero
Contact Person Email
martina.garnero@hsanmartino.it
Site Name
Instituto Di Ricovero E Cura A Carattere Scientifico
Department Name
Neurology
Contact Person Name
Maria Pia Giannoccaro
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
Neurology
Contact Person Name
Manlio Sgarzi
Contact Person Email
msgarzi@asst-pg23.it
Site Name
Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana
Department Name
Cerebro-cardio-vascular Department
Contact Person Name
Domenico Marco Bonifati

Sweden

Earliest CTIS Part Ii Submission Date
21-11-2024
Latest Decision Or Authorization Date
23-01-2025
Processing Time Days
63
Number Of Sites
3
Number Of Participants
2

Sites

Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Neurologi, MS centrum
Contact Person Name
Daniel Jons
Contact Person Email
daniel.jons@vgregion.se
Site Name
Region Vaermland
Department Name
Neurologi och Rehabiliteringskliniken
Contact Person Name
Oskar Wickberg
Site Name
Danderyds Sjukhus AB
Department Name
Neurologmottagning
Contact Person Name
Niclas Lange

Germany

Earliest CTIS Part Ii Submission Date
18-10-2024
Latest Decision Or Authorization Date
13-11-2024
Processing Time Days
26
Number Of Sites
10
Number Of Participants
7

Sites

Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Department of Neurology
Contact Person Name
Tobias Ruck
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Department of Neurology
Contact Person Name
Sarah Hoffmann
Contact Person Email
sarah.hoffmann@charite.de
Site Name
Technische Universitaet Dresden
Department Name
Department of Neurology
Contact Person Name
Jochen Schaefer
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Department of Neurology
Contact Person Name
Angela Rosenbohm
Contact Person Email
angela.rosenbohm@uni-ulm.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Department of Neurology
Contact Person Name
Julian Grosskreutz
Site Name
Medizinische Hochschule Hannover
Department Name
Neurology Clinic
Contact Person Name
Thomas Skripuletz
Site Name
Universitaet Leipzig
Department Name
Clinic and Policlinic for Neurology
Contact Person Name
Florian Then Bergh
Site Name
Klinikum Oberberg GmbH
Department Name
Department of Neurology
Contact Person Name
Franz Blaes
Site Name
St. Josef-Hospital
Department Name
Department of Neurology
Contact Person Name
Christiane Schneider-Gold
Site Name
Universitaetsmedizin Goettingen
Department Name
Department of Neurology
Contact Person Name
Jana Zschuentzsch

Hungary

Earliest CTIS Part Ii Submission Date
17-12-2024
Latest Decision Or Authorization Date
27-02-2025
Processing Time Days
72
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
University Of Szeged
Department Name
Neurológiai Klinika
Contact Person Name
Péter Klivényi
Contact Person Email
klivenyi.peter@med.u-szeged.hu
Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Neurológiai Osztály
Contact Person Name
Attila Csányi
Contact Person Email
csanyia@petz.gyor.hu

France

Earliest CTIS Part Ii Submission Date
30-10-2024
Latest Decision Or Authorization Date
07-11-2024
Processing Time Days
8
Number Of Sites
10
Number Of Participants
10

Sites

Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Neurologie
Contact Person Name
Aleksandra NADAJ-PAKLEZA
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Neurologie
Contact Person Name
Céline TARD
Contact Person Email
celine.tard@chu-lille.fr
Site Name
Assistance Publique Hopitaux De Paris (Creteil)
Department Name
Neurologie
Contact Person Name
Edoardo MALFATTI
Contact Person Email
Edoardo.malfatti@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Neurologie
Contact Person Name
Saskia BRESCH
Contact Person Email
bresch.s@chu-nice.fr
Site Name
Hospices Civils De Lyon
Department Name
Neurologie
Contact Person Name
Françoise BOUHOUR
Contact Person Email
francoise.bouhour@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Neurologie
Contact Person Name
Emmeline LAGRANGE
Contact Person Email
ELagrange@chu-grenoble.fr
Site Name
Assistance Publique Hopitaux De Paris (Creteil - another site)
Department Name
Neurologie
Contact Person Name
Antony BEHIN
Contact Person Email
anthony.behin@aphp.fr
Site Name
CHU Gabriel-Montpied (Clermont Ferrand)
Department Name
Neurologie
Contact Person Name
Frederic TAITHE
Contact Person Email
ftaithe@chu-clermontferrand.fr
Site Name
Fondation A De Rothschild (Paris)
Department Name
Neurologie
Contact Person Name
Antoine GUEGUEN
Contact Person Email
agueguen@for.paris
Site Name
Centre Hospitalier Universitaire De Nice (additional entry)
Department Name
Neurologie

Sponsor

Primary sponsor

Full Name
Merck Healthcare KGaA
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
IQVIA Limited
Responsibilities
Multiple study operations functions (codes include 1,2,5,6,8,10,11,12,15); Interactive Response Technologies (Cenduit).
Name
ICON Clinical Research Limited
Responsibilities
eCOA - Licencing, linguistic validation & translation.
Name
IQVIA RDS Hellas Single Member S.A.
Responsibilities
Site-level trial support / local operational duties (codes 1,12,8).
Name
Medable Inc.
Responsibilities
eCOA/eConsent platform support and related services (codes 6 and 7).
Name
Medidata Solutions Inc.
Responsibilities
eClinical platform support (codes 6 and 7).

Third parties

  • {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"Sample storage; code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Thermo Fisher Scientific Inc.","duties_or_roles":"code 14","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Nuvisan GmbH","duties_or_roles":"Sample storage; code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Sample Storage; code 6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"ePRO/eCOA (MG-ADL and QMG) Rater Training","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"code 4; code 6","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Unisphere Travel Ltd. Inc.","duties_or_roles":"Patient recruitment and advisory","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Quest Diagnostics Nichols Institute Inc.","duties_or_roles":"Sample storage; code 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Multiple responsibilities including Interactive Response Technologies (Cenduit), and codes 1,2,5,6,8,10,11,12,15","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Inato","duties_or_roles":"Patient recruitment and advisory","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"International Drug Development Institute","duties_or_roles":"Independent statistical data analysis center to perform the interim analysis and report the results to External DMC.","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"codes 6 and 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Sample storage; code 4; code 6","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"France","full_name":"Mapi Research Trust","duties_or_roles":"eCOA - Licencing, linguistic validation & translation.","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"codes 1,12,8","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Belgium","full_name":"CluePoints","duties_or_roles":"Risk-Based Quality Management / Central Monitoring","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Stichting EuroQol Research Foundation","duties_or_roles":"ePRO Licensing (EQ-5D-5L)","organisation_type":"Patient organisation/association"}
  • {"country":"Switzerland","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"code 14","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"eCOA - Licencing, linguistic validation & translation.","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH (additional entry)","duties_or_roles":"Sample Storage; code 6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medable Inc.","duties_or_roles":"codes 6 and 7","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Switzerland","full_name":"Fisher Clinical Services GmbH (Basel)","duties_or_roles":"code 14","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Provide rental ancillary supplies","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
cladribine
Active Substance
CLADRIBINE
Modality
Small molecule
Routes Of Administration
ORAL
Route
Oral
Authorisation Status
Authorised (prodAuthStatus=1; EU MP number PRD11027046)
Dose Levels
High dose and Low dose regimens described (no numeric doses provided in Part I summary).
Frequency
Administered as 2 separate treatment courses starting on Day 1 and at the beginning of Week 5 (per DBPC period); retreatment/regimens in extension/retreatment periods as clinically justified.
Investigational Product Name
Cladribine Placebo
Modality
Other (placebo)
Frequency
Oral placebo as 2 separate treatment courses starting on Day 1 and at the beginning of Week 5 (matched to active dosing schedule).
Investigational Product Name
Shingrix powder and suspension for suspension for injection Herpes zoster vaccine (recombinant, adjuvanted)
Active Substance
RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E
Modality
Vaccine
Routes Of Administration
INTRAMUSCULAR INJECTION
Route
Intramuscular
Authorisation Status
Authorised (marketingAuthNumber EU/1/18/1272/001; prodAuthStatus=2)
Starting Dose
0.5 ml (maxTotalDoseAmount 0.5 ml indicated in product record)
Dose Levels
Single vaccination dosing as per MA/SmPC (used as auxiliary vaccine per MA).
Frequency
Per marketing authorisation; max total dose amount 0.5 ml
Maximum Dose
0.5 ml

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