Myasthenia Gravis Clinical Trials

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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm, 3-Period Study to Assess the Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)

Status: Recruiting
Location: See all (132) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this clinical study is to determine the efficacy and safety of a new oral cladribine formulation in participants with Generalized Myasthenia Gravis (gMG) in comparison to placebo. It will also investigate the sustained efficacy, the need for retreatment, and the long-term safety of oral cladribine in gMG. An additional component is included to characterize the Pharmacokinetics (PK) of the new cladribine formulation in gMG participants. This study is divided into 3 periods: the double-blind placebo control (DBPC) pivotal period, and 2 extensions, the blinded extension (BE) and the retreatment (RT) period.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults of ≥ 18 years of age at the time of signing the informed consent.

• 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)

• Has a Screening and Baseline MG-ADL score more than or equal to (\>=) 6 with \>= 50 percentage (%) 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

• 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

• If treated with acetylcholinesterase inhibitor should be on a stable daily dose (pyridostigmine dose ≤ 480 mg/day) for at least 3 months prior to and during screening

• Have a body weight \>= 40 kilograms

• Other protocol defined inclusion criteria could apply

Locations
United States
Arizona
Arizona Neuroscience Research, LLC
RECRUITING
Phoenix
Colorado
Advanced Neurosciences Research LLC
RECRUITING
Longmont
Washington, D.c.
The George Washington University Medical Faculty Associates Foggy Bottom South Pavilion
RECRUITING
Washington D.c.
Florida
Neurology of Central Florida Research Center, LLC
RECRUITING
Altamonte Springs
SFM Clinical Research, LLC
RECRUITING
Boca Raton
University of Florida Health Science Center - 300120311
RECRUITING
Jacksonville
Neurology Associates, P. A.
RECRUITING
Maitland
University of South Florida - PARENT - PARENT
RECRUITING
Tampa
Kansas
University of Kansas Medical Center Research Institute, Inc. - 3901 Rainbow (MAIN)
RECRUITING
Kansas City
North Carolina
UNC Hospitals - PARENT
RECRUITING
Chapel Hill
Atrium Health Wake Forest Baptist
RECRUITING
Winston-salem
Ohio
Miami Valley Hospital South
RECRUITING
Centerville
South Carolina
Clinical Trials of South Carolina - Charleston
RECRUITING
Charleston
Tennessee
Erlanger Health, Inc. - 1123255
RECRUITING
Chattanooga
Texas
Baylor Scott & White Research Institute - Baylor Scott & White Research Institute
RECRUITING
Dallas
ANESC Research
RECRUITING
El Paso
Baylor Scott & White Neurology - McKinney
RECRUITING
Mckinney
Virginia
Integrated Neurology Services - Dr. Simon Fishman's Office
RECRUITING
Falls Church
Vermont
The University of Vermont Medical Center
RECRUITING
Burlington
Other Locations
Argentina
Expertia S.A- Mautalen Salud e Investigación
RECRUITING
Ciudad Autonoma Buenos Aires
Instituto de Investigaciones Metabolicas (IDIM)
RECRUITING
Ciudad Autonoma Buenos Aires
Instituto de Investigaciones Neurologicas Raul Carrea, FLENI - de Investigaciones Clinicas del área de Cardiología y enfermedades metabólicas asociadas
RECRUITING
Ciudad Autonoma Buenos Aires
Hospital Cordoba
RECRUITING
Córdoba
Fundacion Rosarina de Neurorehabilitacion
RECRUITING
Rosario
INECO Neurociencias Oroño
RECRUITING
Rosario
CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
RECRUITING
San Juan
Centro de Investigaciones Medicas Tucuman
RECRUITING
San Miguel De Tucumán
Australia
Sunshine Coast University Hospital
RECRUITING
Birtinya
Box Hill Hospital - PARENT
RECRUITING
Box Hill
John Hunter Hospital - PARENT
RECRUITING
City Of Burnside
Gold Coast University Hospital - PARENT
RECRUITING
Southport
Belgium
UZ Leuven
RECRUITING
Leuven
C. H. R. de la Citadelle - Account 1
RECRUITING
Liège
Bulgaria
Medical Center Hera - branch Montana
RECRUITING
Montana
UMHAT 'Dr. Georgi Stranski', EAD
RECRUITING
Pleven
UMHAT Sv. Georgi, EAD
RECRUITING
Plovdiv
MHATNP Sv.Naum, EAD - Third Neurology Clinic
RECRUITING
Sofia
UMHATEM 'N.I. Pirogov', EAD
RECRUITING
Sofia
China
The First Affiliated Hospital of Bengbu Medical College
RECRUITING
Anhui Sheng
Peking Union Medical College Hospital
RECRUITING
Beijing
Xuanwu Hospital Capital Medical University
RECRUITING
Beijing
China-Japan Union Hospital of Jilin University - 300173736
RECRUITING
Changchun
The First Hospital of Jilin University - The First Hospital of Jilin University
RECRUITING
Changchun
Xiangya Hospital, Central South University
RECRUITING
Changsha
West China Hospital, Sichuan University
RECRUITING
Chengdu
The First Affiliated Hospital of Guangzhou University of Chinese Medicine - 300164595
RECRUITING
Guangzhou
Huashan Hospital, Fudan University - Neurology
RECRUITING
Shanghai
Shengjing Hospital of China Medical University
RECRUITING
Shenyang
Shijiazhuang People's Hospital
RECRUITING
Shijiazhuang
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
RECRUITING
Wuhan
Xi 'an International Medical Center
RECRUITING
Xi’an
Henan Provincial People's Hospital
RECRUITING
Zhengzhou
Affiliated Hospital of Zunyi Medical University
RECRUITING
Zunyi
France
Hopital Neurologique Pierre Wertheimer - Pathologies neuro-musculaires. Electromyographie
RECRUITING
Bron
CHU Clermont Ferrand - Hopital Gabriel Montpied - service de neurologie B
RECRUITING
Clermont-ferrand
Hôpital Henri Mondor - Service de Neurologie
RECRUITING
Créteil
CHU de Grenoble - Hôpital Albert Michallon - Centre de Références des Maladies Neuromusculaires
RECRUITING
La Tronche
CHU Nice - Hôpital Pasteur - Cardiology
RECRUITING
Nice
Fondation Ophtalmologique Adolphe de Rothschild - Service de neurologie
RECRUITING
Paris
Groupe Hospitalier Pitie-Salpetriere - Centre Référent Maladies Rares SLA - Neurologie
RECRUITING
Paris
CHU Strasbourg - Hopital Hautepierre - Service Anesthesie-Reanimation&Medecine Peri-Opera
RECRUITING
Strasbourg
Georgia
Aversi Clinic Ltd
RECRUITING
Tbilisi
Ltd. Pineo Medical Ecosystem
RECRUITING
Tbilisi
New Hospitals LLC
RECRUITING
Tbilisi
Germany
Charité Universitaetsmedizin Berlin - Campus Charité Mitte - Klinik fuer Neurologie
RECRUITING
Berlin
St. Joseph Hospital - St. Joseph Hospital Haan
RECRUITING
Bochum
Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I
RECRUITING
Dresden
Universitaetsmedizin Goettingen - Abteilung fuer Nephrologie und Rheumatologie
RECRUITING
Göttingen
Medizinische Hochschule Hannover - Klinik fur Neurologie mit Klinischer Neurophysiol
RECRUITING
Hanover
Universitaetsklinikum Leipzig AoeR - Klinik und Poliklinik fuer Neurologie
RECRUITING
Leipzig
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck - Neurologie
RECRUITING
Lübeck
Greece
University General Hospital of Larissa - Rheumatology Clinic
RECRUITING
Larissa
University Hospital of Patra
RECRUITING
Pátrai
AHEPA General Hospital of Thessaloniki
RECRUITING
Thessaloniki
Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont - Neurologiai Klinika
RECRUITING
Szeged
India
Bangalore Medical College and Victoria Hospital - 300148268
RECRUITING
Bangalore
St John's Medical College Hospital
RECRUITING
Bangalore
Nizam's Institute of Medical Sciences
RECRUITING
Hyderabad
Yashoda Super Speciality Hospital - 300158817
RECRUITING
Hyderabad
Mallikatta Neurocentre
RECRUITING
Mangalore
Chopda Medicare & Research Centre - 300188248
RECRUITING
Nashik
Deenanath Mangeshkar Hospital and Research Centre - Department of Neurology
RECRUITING
Pune
Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni
RECRUITING
Bergamo
IRCCS Istituto delle Scienze Neurologiche di Bologna - Unità Operativa Complessa Clinica Neurologica
RECRUITING
Bologna
IRCCS Ospedale Policlinico San Martino - Neuroradiologia
RECRUITING
Genova
Fondazione IRCCS Istituto Neurologico Carlo Besta
RECRUITING
Milan
Fondazione Istituto Neurologico Casimiro Mondino - Neurology
RECRUITING
Pavia
Azienda Ospedaliera Universitaria Policlinico Tor Vergata - U.O.C. Neurologia
RECRUITING
Roma
Policlinico Universitario Agostino Gemelli - UOC Neurologia
RECRUITING
Rome
Ospedale ca' Foncello - Neurology
RECRUITING
Treviso
Japan
Chiba University Hospital - Dept of Neurology
RECRUITING
Chiba
Fukuoka University Hospital - Dept of Neurology/Health Care
RECRUITING
Fukuoka
Hakodate Municipal Hospital - Dept of Neurology
RECRUITING
Hakodate-shi
General Hanamaki Hospital - Dept of Neurology
RECRUITING
Hanamaki-shi
Saitama Medical University Hospital - Dept of Neurology/Stroke Care Unit
RECRUITING
Iruma-gun
Kagawa University Hospital - Dept of Neurology
RECRUITING
Kita-gun
Southern Tohoku Medical Clinic - Dept of Neurology
RECRUITING
Koriyama-shi
Toho University Ohashi Medical Center - Dept of Neurology
RECRUITING
Meguro-ku
Nagasaki University Hospital - Dept of Neurology
RECRUITING
Nagasaki
IUHW Narita Hospital - Dept of Neurology
RECRUITING
Narita-shi
Tokyo Medical University Hospital - Dept of Neurology
RECRUITING
Shinjuku-ku
Osaka University Hospital - Dept of Neurology/Stroke Care Unit
RECRUITING
Suita-shi
Poland
Uniwersyteckie Centrum Kliniczne - Dept of Neurology
RECRUITING
Gdansk
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii Klinicznej
RECRUITING
Krakow
MTZ Clinical Research Powered By Pratia
RECRUITING
Warsaw
Wielospecjalistyczne Centrum Medyczne Ibismed - Dept of Neurology
RECRUITING
Zabrze
Republic of Korea
Kyungpook National University Chilgok Hospital
RECRUITING
Daegu
Chonnam National University Hospital
RECRUITING
Gwangju
Asan Medical Center
RECRUITING
Seoul
Keimyung University Dongsan Hospital
WITHDRAWN
Seoul
Korea University Anam Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul Metropolitan Government Seoul National University Boramae Medical Center
RECRUITING
Seoul
Romania
Institutul Clinic Fundeni - parent
RECRUITING
Bucharest
S.C Neurocity S.R.L
RECRUITING
Bucharest
Brainaxy Clinic S.R.L.
RECRUITING
Constanța
Spitalul Clinic Judetean de Urgenta Targu Mures - Sectia Clinica Neurologie I
RECRUITING
Târgu Mureş
Spain
Hospital Universitari Germans Trias i Pujol - Servicio de Neurologia
RECRUITING
Badalona
Hospital Universitari Vall d'Hebron - Neurology Dept
RECRUITING
Barcelona
Hospital Universitario Reina Sofia - Neurology Dept
RECRUITING
Córdoba
Hospital Universitario Central de Asturias - Servicio de Neurologia
RECRUITING
Oviedo
Hospital Universitari i Politecnic La Fe - Pediatry Department
RECRUITING
Valencia
Sweden
Sahlgrenska Sjukhuset
RECRUITING
Gã¶teborg
Centralsjukhuset Karlstad
RECRUITING
Karlstad
Danderyd Sjukhus - 300147691
RECRUITING
Stockholm
Switzerland
Inselspital - Universitaetsspital Bern - Neuropsychologische Rehabilitation, Neurologie
RECRUITING
Bern
Taiwan
Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
China Medical University Hospital
RECRUITING
Taichung
Shin Kong Wu Ho-Su Memorial Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
United Kingdom
Nottingham University Hospitals NHS Trust
RECRUITING
Nottingham
Royal Hallamshire Hospital - Dept of Neurology
RECRUITING
Sheffield
Contact Information
Primary
US Medical Information
eMediUSA@emdserono.com
888-275-7376
Backup
Communication Center
service@emdgroup.com
+49 6151 72 5200
Time Frame
Start Date: 2024-06-25
Estimated Completion Date: 2030-08-19
Participants
Target number of participants: 264
Treatments
Placebo_comparator: Placebo
DBPC Period: Participants will be administered with Placebo, orally as 2 separate treatment courses starting on Day 1 and at the beginning of Week 5.~BE Period: Participants initially randomized to placebo matched to cladribine in DBPC period will receive cladribine Low Dose or High Dose, orally as 2 separate treatment courses starting at the beginning of Week 25 and at the beginning of Week 29 and retreated if clinically justified with placebo matched to cladribine.~RT Period: Participants requiring retreatment with cladribine Low Dose or High Dose or retreated with cladribine supplemental dose if clinically justified.
Experimental: Cladribine Low Dose
DBPC Period: Participants will be administered with cladribine Low Dose, orally as 2 separate treatment courses starting on Day 1 and at the beginning of Week 5.~BE Period: Participants initially randomized to cladribine Low Dose in DBPC period will receive placebo matched to cladribine as 2 separate treatment courses starting at the beginning of Week 25 and at the beginning of Week 29 and retreated with cladribine supplemental dose if clinically justified.~RT Period: Participants requiring retreatment with cladribine Low Dose regimen and/or supplemental dose will receive the selected dose of cladribine if clinically justified.
Experimental: Cladribine High Dose
DBPC Period: Participants will be administered cladribine High Dose, orally as 2 separate treatment courses starting on Day 1 and at the beginning of Week 5.~BE Period: Participants initially randomized to cladribine High Dose in DBPC period will receive placebo matched to cladribine as 2 separate treatment courses starting at the beginning of Week 25 and at the beginning of Week 29 and retreated with cladribine supplemental dose if clinically justified.~RT Period: Participants requiring retreatment with cladribine High Dose regimen and/or supplemental dose will receive the selected dose of cladribine if clinically justified.
Related Therapeutic Areas
Sponsors
Collaborators: EMD Serono Research & Development Institute, Inc.
Leads: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

This content was sourced from clinicaltrials.gov

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