AzTrials
AzTrials

Generalized Myasthenia GravisPhase 3NCT06463587

Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)

A Phase 3 study testing Cladribine Low Dose and Cladribine High Dose in people with Generalized Myasthenia Gravis, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 154 sites in 25 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Generalized Myasthenia Gravis
What is being tested?
Cladribine Low Dose and Cladribine High Dose
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
264 participants
Where
154 sitesin 25 countries
Study dates
25 Jun 2024to 12 Nov 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 i.e. not positive for anti-AChR and anti-MuSK antibodies 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, 16 mg/day for methylprednisolone, 3 mg/day for dexamethasone, or 80 mg for hydrocortisone or equivalent doses for other corticosteroids.
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  • If treated with acetylcholinesterase inhibitor should be on a stable daily dose (pyridostigmine dose ≤ 480 mg/day or neostigmine ≤ 300 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

Who cannot join

  • 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
  • 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
  • Active, clinically significant viral, bacterial, or fungal infection, including brain MRI or chest X-ray findings consistent with signs of infection such as PML or TB, 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. Vaginal candidiasis, onychomycosis, and genital or oral herpes simplex virus considered by the Investigator to be sufficiently controlled would not be exclusionary
  • Has a history of or current diagnosis of active tuberculosis (TB) or is currently undergoing treatment for latent TB infection or has an untreated latent TB infection as determined by documented results within 3 months of the Screening Visit of a positive TB skin test .
  • Active malignancy, or history of cancer or signs of malignancy in any Screening assessment
  • Treatment with nonsteroidal immunosuppressants, used in gMG, such as azathioprine, mycophenolate mofetil, methotrexate, cyclosporine, cyclophosphamide, tacrolimus within 4 weeks prior to randomization
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  • Treatment with FcRn or complement inhibitors (such as eculizumab, rozanolixizumab efgartigimod, ravulizumab, zilucoplan or nipocalimab) within 8 weeks prior to randomization
  • History of thymectomy within 6 months prior to Screening.
  • History of generalized seizures (except for history of febrile seizures during the participant's childhood).
  • Negative or indeterminate for Varicella Zoster Virus antibodies at screening
  • History of myasthenic crisis in the last 12 months prior to and during screening
  • History of recurrent infections (that is 3 or more infections per year documented in available source data) within the last 2 years
  • Discontinuation of treatment with any non-steroidal immunosuppressants used in gMG, such as azathioprine, mycophenolate mofetil, methotrexate, cyclosporine, cyclophosphamide, tacrolimus within the last 6 months prior to Screening
  • If treated with non-steroidal immunosuppressants for gMG, the dose at Screening higher than 50 mg/day for azathioprine, 500 mg/day for mycophenolate mofetil, 1 mg/day for tacrolimus, 50 mg/day for cyclosporine, 25 mg/day for cyclophosphamide, or 7.5 mg/week for methotrexate
  • 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
  • Other protocol defined exclusion criteria could apply

Trial locations and contacts

154 sites in 25 countries. Contact the study team or a site near you to ask about taking part.

US Medical Information contact

888-275-7376

eMediUSA@emdserono.com

Communication Center contact

+49 6151 72 5200

service@emdgroup.com

154 sites in 25 countries

United States22 sites, 20 recruiting

  • Neurology of Central Florida Research Center, LLC

    Altamonte Springs, Florida, 32714

    neuroresearchcfl@gmail.com

    Alicia V Cabrera

    Recruiting

  • SFM Clinical Research, LLC

    Boca Raton, Florida, 33487

    marc.feinberg@sfmresearch.com

    Marc H Feinberg

    Recruiting

  • The University of Vermont Medical Center

    Burlington, Vermont, 05401

    rup.tandan@uvmhealth.org

    Rup Tandan

    Recruiting

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

    jpwilliams@premierhealth.com

    Jon P Williams

    Recruiting

  • UNC Hospitals - PARENT

    Chapel Hill, North Carolina, 27599

    howardj@neurology.unc.edu

    James F Howard

    Recruiting

  • Clinical Trials of South Carolina - Charleston

    Charleston, South Carolina, 29406

    dstickler@neurologycharleston.com

    David E Stickler

    Recruiting

  • Erlanger Health, Inc. - 1123255

    Chattanooga, Tennessee, 37403

    chelsea.shugars@erlanger.org

    Chelsea A Shugars

    Recruiting

  • University of Cincinnati

    Cincinnati, Ohio, 45219

    hani.kushlaf@uc.edu

    Hani Kushlaf

    Recruiting

  • Baylor Scott & White Research Institute - Baylor Scott & White Research Institute

    Dallas, Texas, 75246

    desirae.ransom@bswhealth.org

    Niloofar Yari

    Recruiting

  • ANESC Research

    El Paso, Texas, 79912

    aherekarresearch@anesc.net

    Aamr A Herekar

    Recruiting

  • Integrated Neurology Services - Dr. Simon Fishman's Office

    Falls Church, Virginia, 22043

    Active, not recruiting

  • University of Connecticut Health Center - Department of Medicine

    Farmington, Connecticut, 06030-5550

    alhernandez@uchc.edu

    Amanda Hernandez

    Recruiting

  • BCN Research

    Greenfield, Wisconsin, 53288

    milwaukee4145@gmail.com

    Bhupendra O Khatri

    Recruiting

  • University of Florida Health Science Center - 300120311

    Jacksonville, Florida, 32209

    michael.pulley@jax.ufl.edu

    Michael T Pulley

    Recruiting

  • University of Kansas Medical Center Research Institute, Inc. - 3901 Rainbow (MAIN)

    Kansas City, Kansas, 66160

    mpasnoor@kumc.edu

    Mamatha Pasnoor

    Recruiting

  • Advanced Neurosciences Research LLC

    Longmont, Colorado, 80501

    Active, not recruiting

  • Neurology Associates, P. A.

    Maitland, Florida, 32751

    adslansky@gmail.com

    Adam D Slansky

    Recruiting

  • Baylor Scott & White Neurology - McKinney

    McKinney, Texas, 75071

    francy.shu@bswhealth.org

    Francy Shu

    Recruiting

  • Arizona Neuroscience Research, LLC

    Phoenix, Arizona, 85032

    drzuniga@centerforneurologyandspine.com

    Leslie Zuniga

    Recruiting

  • University of South Florida - PARENT - PARENT

    Tampa, Florida, 33612

    tvu6@usf.edu

    Tuan H Vu

    Recruiting

  • The George Washington University Medical Faculty Associates Foggy Bottom South Pavilion

    Washington D.C., District of Columbia, 20037

    hkaminski@mfa.gwu.edu

    Henry J Kaminski

    Recruiting

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina, 27157-1078

    rgandhi@wakehealth.edu

    Rachana B Gandhi Mehta

    Recruiting

Other trials in United States

China15 sites, 15 recruiting

  • The First Affiliated Hospital of Bengbu Medical College

    Anhui Sheng, Anhui, 233000

    757720064@qq.com

    Weidong Qian

    Recruiting

  • Xuanwu Hospital Capital Medical University

    Beijing, Beijing Municipality, 100053

    dayuwei1000@163.com

    Yuwei Da

    Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    guanyz001@163.com

    Yuzhou Guan

    Recruiting

  • The First Hospital of Jilin University - The First Hospital of Jilin University

    Changchun, Jilin, 130021

    hui_deng_2013@163.com

    Hui Deng

    Recruiting

  • China-Japan Union Hospital of Jilin University - 300173736

    Changchun, Jilin, 130033

    yan1966@163.com

    Songyan Liu

    Recruiting

  • Xiangya Hospital, Central South University

    Changsha, Hu'nan, 410008

    yangh69@126.com

    Huan Yang

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    zhy16645@outlook.com

    Hongyu Zhou

    Recruiting

  • The First Affiliated Hospital of Guangzhou University of Chinese Medicine - 300164595

    Guangzhou, Guangdong, 510405

    jiangqilong5119@gzucm.edu.cn

    Qilong Jiang

    Recruiting

  • Huashan Hospital, Fudan University - Neurology

    Shanghai, Shanghai Municipality, 200040

    luosushan@fudan.edu.cn

    Sushan Luo

    Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

    sjnkfeng@163.com

    Juan Feng

    Recruiting

  • Shijiazhuang People's Hospital

    Shijiazhuang, Hebei, 050000

    zzjwlzxgcp@163.com

    Guoyan Qi

    Recruiting

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

    Wuhan, Hubei, 430030

    zjlhuazhong@163.com

    Zhijun Li

    Recruiting

  • Xi 'an International Medical Center

    Xi’an, Shanxi, 710038

    linh.312@163.com

    Hong Lin

    Recruiting

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450003

    macklon12@163.com

    Mingming Ma

    Recruiting

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou, 563099

    docxzc@126.com

    Zucai Xu

    Recruiting

Other trials in China

Japan12 sites, 12 recruiting

  • Chiba University Hospital - Dept of Neurology

    Chiba, Chiba, 260-8677

    auzawa@chiba-u.jp

    Akiyuki Uzawa

    Recruiting

  • Fukuoka University Hospital - Dept of Neurology/Health Care

    Fukuoka, Fukuoka, 814-0180

    ybaba@fukuoka-u.ac.jp

    Yasuhiko Baba

    Recruiting

  • Hakodate Municipal Hospital - Dept of Neurology

    Hakodate-shi, Hokkaido, 392006

    horiuchi-kazuhiro@hotmail.co.jp

    Kazuhiro Horiuchi

    Recruiting

  • General Hanamaki Hospital - Dept of Neurology

    Hanamaki-shi, Iwate, 025-0082

    kutsugisawa@gmail.com

    Kimiaki Utsugisawa

    Recruiting

  • Saitama Medical University Hospital - Dept of Neurology/Stroke Care Unit

    Iruma-gun, Saitama, 350-0495

    g_oyama@juntendo.ac.jp

    Genko Omaya

    Recruiting

  • Kagawa University Hospital - Dept of Neurology

    Kita-gun, Kagawa-ken, 7610793

    kawakita.rie.h4@kagawa-u.ac.jp

    Rie Kawakita

    Recruiting

  • Southern Tohoku Medical Clinic - Dept of Neurology

    Koriyama-shi, Fukushima, 963-8563

    kanekochikako_chiken@yahoo.co.jp

    Chikako Kaneko

    Recruiting

  • Toho University Ohashi Medical Center - Dept of Neurology

    Meguro-ku, Tokyo-To, 153-8515

    d500372@oha.toho-u.ac.jp

    Shingo Konno

    Recruiting

  • Nagasaki University Hospital - Dept of Neurology

    Nagasaki, Nagasaki, 852-8501

    shun1982.shun@gmail.com

    Shunsuke Yoshimura

    Recruiting

  • IUHW Narita Hospital - Dept of Neurology

    Narita-shi, Chiba, 286-8520

    murai@iuhw.ac.jp

    Hiroyuki Murai

    Recruiting

  • Tokyo Medical University Hospital - Dept of Neurology

    Shinjuku-ku, Tokyo-To, 160-0023

    msd_cli@yahoo.co.jp

    Masayuki Masuda

    Recruiting

  • Osaka University Hospital - Dept of Neurology/Stroke Care Unit

    Suita-shi

    takahashi.masanori.sahs.med@osaka-u.ac.jp

    Masanori Takahashi

    Recruiting

Other trials in Japan

Germany9 sites, 9 recruiting

  • Charité Universitaetsmedizin Berlin - Campus Charité Mitte - Klinik fuer Neurologie

    Berlin, 10117

    sarah.hoffmann@charite.de

    Sarah Hoffmann

    Recruiting

  • St. Joseph Hospital - St. Joseph Hospital Haan

    Bochum, North Rhine-Westphalia, 44791

    christiane.schneider-gold@rub.de

    Christiane Schneider-Gold

    Recruiting

  • Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I

    Dresden, Saxony, 01307

    jochen.schaefer@ukdd.de

    Jochen Schaefer

    Recruiting

  • Universitaetsklinikum Duesseldorf AoeR - Klinik fuer Neurologie

    Düsseldorf, North Rhine-Westphalia, 40225

    michael.gliem@uni-duesseldorf.de

    Michael Gliem

    Recruiting

  • Universitaetsmedizin Goettingen - Abteilung fuer Nephrologie und Rheumatologie

    Göttingen, Lower Saxony, 37075

    j.zschuentzsch@med.uni-goettingen.de

    Jana Zschuentzsch

    Recruiting

  • Medizinische Hochschule Hannover - Klinik fur Neurologie mit Klinischer Neurophysiol

    Hanover, Lower Saxony, 30625

    skripuletz.thomas@mh-hannover.de

    Thomas Skripuletz

    Recruiting

  • Universitaetsklinikum Leipzig AoeR - Klinik und Poliklinik fuer Neurologie

    Leipzig, Saxony, 04103

    florian.thenbergh@medizin.uni-leipzig.de

    Florian Then Bergh

    Recruiting

  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck - Neurologie

    Lübeck, Schleswig-Holstein, 23562

    julian.grosskreutz@uni-luebeck.de

    Julian Grosskreutz

    Recruiting

  • Universitaetsklinikum Ulm - Klinik fuer Neurologie

    Ulm, Baden-Wurttemberg, 89081

    angela.rosenbohm@uni-ulm.de

    Angela Rosenbohm

    Recruiting

Other trials in Germany

Argentina8 sites, 8 recruiting

  • Expertia S.A- Mautalen Salud e Investigación

    Ciudad Autonoma Buenos Aires, 1427

    vsalutto@gmail.com

    Valeria Salutto

    Recruiting

  • Instituto de Investigaciones Neurologicas Raul Carrea, FLENI - de Investigaciones Clinicas del área de Cardiología y enfermedades metabólicas asociadas

    Ciudad Autonoma Buenos Aires, 1428

    arivero@fleni.org.ar

    Alberto Daniel Rivero

    Recruiting

  • Instituto de Investigaciones Metabolicas (IDIM)

    Ciudad Autonoma Buenos Aires, C1012AAR

    fatipagani@gmail.com

    Fatima Pagani Cassara

    Recruiting

  • Hospital Cordoba

    Córdoba

    su_neuro@hotmail.com

    Susana del Liwacki

    Recruiting

  • Fundacion Rosarina de Neurorehabilitacion

    Rosario

    carolinamainella@yahoo.com.ar

    Carolina Mainella

    Recruiting

  • INECO Neurociencias Oroño

    Rosario

    dtavolini@inecoorono.org

    Dario Tavolini

    Recruiting

  • CER San Juan Centro Polivalente de Asistencia e Inv. Clinica

    San Juan, 5400

    jcgiugni@gmail.com

    Juan Carlos Giugni

    Recruiting

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán

    gustavojose1973@yahoo.com.ar

    Jorge Jose

    Recruiting

Other trials in Argentina

France8 sites, 8 recruiting

  • Hopital Neurologique Pierre Wertheimer - Pathologies neuro-musculaires. Electromyographie

    Bron, Rhone, 69677

    francoise.bouhour@chu-lyon.fr

    Francoise Bouhour

    Recruiting

  • CHU Clermont Ferrand - Hopital Gabriel Montpied - service de neurologie B

    Clermont-Ferrand, Puy De Dome, 63003

    ftaithe@chu-clermontferrand.fr

    Frederic Taithe

    Recruiting

  • Hôpital Henri Mondor - Service de Neurologie

    Créteil, Val De Marne, 94010

    edoardo.malfatti@aphp.fr

    Edoardo Malfatti

    Recruiting

  • CHU de Grenoble - Hôpital Albert Michallon - Centre de Références des Maladies Neuromusculaires

    La Tronche, Isere, 38700

    elagrange@chu-grenoble.fr

    Emmeline Lagrange

    Recruiting

  • CHU Nice - Hôpital Pasteur - Cardiology

    Nice, Alpes Maritimes, 06002

    bresch.s@chu-nice.fr

    Saskia Bresch

    Recruiting

  • Fondation Ophtalmologique Adolphe de Rothschild - Service de neurologie

    Paris, Paris, 75940

    agueguen@for.paris

    Antoine Gueguen

    Recruiting

  • Groupe Hospitalier Pitie-Salpetriere - Centre Référent Maladies Rares SLA - Neurologie

    Paris, 75013

    anthony.behin@aphp.fr

    Anthony Behin

    Recruiting

  • CHU Strasbourg - Hopital Hautepierre - Service Anesthesie-Reanimation&Medecine Peri-Opera

    Strasbourg, Bas Rhin, 67098

    aleksandra.nadaj-pakleza@chru-strasbourg.fr

    Aleksandra Nadaj Pakleza

    Recruiting

Other trials in France

Italy8 sites, 8 recruiting

  • Azienda Socio Sanitaria Territoriale Papa Giovanni

    Bergamo, 24127

    msgarzi@asst-pg23.it

    Manlio Sgarzi

    Recruiting

  • IRCCS Istituto delle Scienze Neurologiche di Bologna - Unità Operativa Complessa Clinica Neurologica

    Bologna, 40139

    mariapia.giannoccar2@unibo.it

    Maria Pia Giannoccaro

    Recruiting

  • IRCCS Ospedale Policlinico San Martino - Neuroradiologia

    Genova, 16132

    martina.garnero@hotmail.it

    Martina Garnero

    Recruiting

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, 20133

    carlo.antozzi@istituto-besta.it

    Carlo G Antozzi

    Recruiting

  • Fondazione Istituto Neurologico Casimiro Mondino - Neurology

    Pavia, 27100

    matteo.gastaldi@mondino.it

    Matteo Gastaldi

    Recruiting

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata - U.O.C. Neurologia

    Rome, 00133

    massa@uniroma2.it

    Roberto Carlo Emilio Massa

    Recruiting

  • Policlinico Universitario Agostino Gemelli - UOC Neurologia

    Rome, 00168

    raffaele.iorio@policlinicogemelli.it

    Raffaele Iorio

    Recruiting

  • Ospedale ca' Foncello - Neurology

    Treviso, 31100

    domenicomarco.bonifati@aulss2.veneto.it

    Domenico Marco Bonifati

    Recruiting

Other trials in Italy

South Korea8 sites, 7 recruiting

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

    jinforeva@gmail.com

    Jin-Sung Park

    Recruiting

  • Chonnam National University Hospital

    Gwangju, 61469

    nts0022@hanmail.net

    Tai Seung Nam

    Recruiting

  • Severance Hospital, Yonsei University Health System - Division of Infectious Diseases

    Seoul, 03722

    hayshin@yuhs.ac

    Ha Young Shin

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    bjkim@skku.edu

    Byoung Joon Kim

    Recruiting

  • Korea University Anam Hospital

    Seoul, 136-705

    nukbj@korea.ac.kr

    Byung-Jo Kim

    Recruiting

  • Asan Medical Center

    Seoul, 138-736

    limy@amc.seoul.kr

    Young-Min Lim

    Recruiting

  • Seoul Metropolitan Government Seoul National University Boramae Medical Center

    Seoul, 156707

    nrhong@gmail.com

    Yoon-Ho Hong

    Recruiting

  • Keimyung University Dongsan Hospital

    Seoul

    Withdrawn

Other trials in South Korea

India7 sites, 7 recruiting

  • Bangalore Medical College and Victoria Hospital - 300148268

    Bangalore, Karnataka, 560002

    dmpraveens@gmail.com

    Praveen Kumar

    Recruiting

  • St John's Medical College Hospital

    Bangalore, Karnataka, 560034

    grk_sarma@yahoo.com

    Gosala R Sarma

    Recruiting

  • Nizam's Institute of Medical Sciences

    Hyderabad, Andhra Pradesh, 500082

    mailforsiree@gmail.com

    Sireesha Yareeda

    Recruiting

  • Yashoda Super Speciality Hospital - 300158817

    Hyderabad, Andhra Pradesh, 500082

    jaydiprc@gmail.com

    Jaydip Ray Chaudhari

    Recruiting

  • Mallikatta Neurocentre

    Mangalore, Karnataka, 575001

    dr.shankaramnc@gmail.com

    Shankara Nellikunja

    Recruiting

  • Chopda Medicare & Research Centre - 300188248

    Nashik, Maharashtra, 422005

    amit_yeole37@rediffmail.com

    Amit Yeole

    Recruiting

  • Deenanath Mangeshkar Hospital and Research Centre - Department of Neurology

    Pune, Maharashtra, 411030

    rahulneuro@gmail.com

    Rahul Kulkarni

    Recruiting

Other trials in India

Turkey (Türkiye)7 sites, 7 recruiting

  • Hacettepe University Medical Faculty - Neurology Department

    Ankara, 06100

    sevimozdamar@yahoo.com

    Sevim Erdem Ozdamar

    Recruiting

  • Ondokuz Mayis Univ. Med. Fac. - Neurology

    Atakum/SAMSUN, 55270

    mterzi@omu.edu.tr

    Murat Terzi

    Recruiting

  • Istanbul University Istanbul Medical Faculty - Neurology

    Istanbul, 34390

    durmushacer@yahoo.com

    Hacer Durmus

    Recruiting

  • Dokuz Eylul University Faculty of Medicine - Neurology Department

    Izmir, 35340

    isengun@deu.edu.tr

    Ihsan Sengun

    Recruiting

  • Kocaeli University Medical Faculty - Neurology Department

    Kocaeli, 41380

    husnuefendi@gmail.com

    Husnu Efendi

    Recruiting

  • Mersin University Medical Faculty - Neurology Department

    Mersin, 33079

    ssevimstudy@gmail.com

    Mustafa Serhan Sevim

    Recruiting

  • Karadeniz Tecnical Uni. Med. Fac. - Neurology Departmen

    Trabzon, 61080

    cavitb@yahoo.com

    Cavit Boz

    Recruiting

Other trials in Turkey (Türkiye)

Australia6 sites, 6 recruiting

  • Sunshine Coast University Hospital

    Birtinya, Queensland, 4575

    antony.winkel@health.qld.gov.au

    Antony Winkel

    Recruiting

  • Box Hill Hospital - PARENT

    Box Hill, Victoria, 3128

    katherine.buzzard@easternhealth.org.au

    Katherine Buzzard

    Recruiting

  • Brain and Mind Research Institute

    Camperdown, New South Wales, 2050

    swreddel@sydneyneurology.com.au

    Stephen Reddel

    Recruiting

  • John Hunter Hospital - PARENT

    City of Burnside, South Australia, SA 5072

    minzuee@yahoo.com.sg

    Myintzu Min

    Recruiting

  • Princess Alexandra Hospital - PARENT

    South Brisbane, Queensland, 4101

    stefan.blum@health.qld.gov.au

    Stefan Blum

    Recruiting

  • Gold Coast University Hospital - PARENT

    Southport

    arman.sabet@health.qld.gov.au

    Arman Sabet

    Recruiting

Other trials in Australia

Bulgaria5 sites, 5 recruiting

  • Medical Center Hera - branch Montana

    Montana, 3400

    drpelov@abv.bg

    Plamen Pelov

    Recruiting

  • UMHAT 'Dr. Georgi Stranski', EAD

    Pleven, 5800

    mdanovska@yahoo.com

    Maya Danovska-Mladenova

    Recruiting

  • UMHAT "Sv. Georgi", EAD

    Plovdiv, 4000

    dr.georgi.slavov@gmail.com

    Georgi Slavov

    Recruiting

  • MHATNP "Sv.Naum", EAD - Third Neurology Clinic

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About this study

Official title: 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)

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. Furthermore, in trial interviews will be conducted as a sub-study to MyClad with a sub-set of participants to gain an in depth understanding of the participant cladribine treatment and study experience.

Being tested
Placebo, Cladribine Low Dose, Cladribine High Dose
Keywords
Anti-AChR antibody positive, anti-MuSK antibody positive, anti-LRP4 antibody positive, seronegative gMG
Medical subject headings
Myasthenia Gravis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboOther

    Participants will receive placebo matched to cladribine in two courses separated by 4 weeks.

  • Cladribine Low DoseDrug

    Participants will receive cladribine low dose in two courses separated by 4 weeks.

  • Cladribine High DoseDrug

    Participants will receive cladribine high dose in two courses separated by 4 weeks.

Study groups in NCT06463587
Study groupRoleWhat they receive
PlaceboPlacebo comparatorDBPC 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: If clinically justified, participants requiring retreatment with cladribine Low Dose or High Dose or cladribine supplemental dose will receive the selected dose of cladribine or matching placebo regimen.
Receives: Other: Placebo; Drug: Cladribine Low Dose; Drug: Cladribine High Dose
Cladribine Low DoseExperimentalDBPC 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: If clinically justified, participants requiring retreatment with cladribine Low Dose regimen and/or supplemental dose will receive the selected dose of cladribine or matching placebo regimen.
Receives: Drug: Cladribine Low Dose
Cladribine High DoseExperimentalDBPC 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: If clinically justified, participants requiring retreatment with cladribine High Dose regimen and/or supplemental dose will receive the selected dose of cladribine or matching placebo regimen.
Receives: Drug: Cladribine High Dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline, Week 24

Secondary outcomes (11)

  1. Change from Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score at Week 24 During the Double-Blind Placebo Controlled (DBPC) Period

    Measured: Baseline, Week 24

  2. Percentage of MG-ADL Responders at Week 24 During the Double-Blind Placebo Controlled (DBPC) Period

    MG-ADL responder is defined by achieving >= 3 points decrease in MG-ADL score.

    Measured: At Week 24

  3. Change from Baseline in Myasthenia Gravis Composite (MGC) Scale Score at Week 24 During the Double-Blind Placebo Controlled (DBPC) Period

    Measured: Baseline, Week 24

  4. Percentage of Quantitative Myasthenia Gravis (QMG) Scale Responders at Week 24 During the Double-Blind Placebo Controlled (DBPC) Period

    QMG responder is defined by achieving >= 4 points decrease in QMG score.

    Measured: At Week 24

  5. Time From Initial Cladribine Full Dose Treatment to First Retreatment or Rescue Treatment up to end of Study

    Measured: Up to End of Study (Week 144)

  6. Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)

    Measured: Up to End of Study (Week 144)

  7. Number of participants with Adverse Events (AEs) by Severity as per National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0

    Measured: Up to End of Study (Week 144)

  8. Number of Participants with Abnormal Laboratory Variables including Absolute Lymphocyte Count and Vital Signs

    Measured: Up to End of Study (Week 144)

  9. Pharmacokinetic (PK) Plasma Concentration of Cladribine

    Measured: Pre-dose, 0.25, 1, 2, 3, 4, 6, 8 and 24 hours post-dose

  10. 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

    Measured: Baseline, Week 24

  11. Number of Participants with Abnormal ECG parameters

    Measured: Up to End of Study (Week 144)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2024
  2. Study start25 Jun 2024
  3. Primary completion23 Aug 2028 (estimated)
  4. Study completion12 Nov 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
264 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06463587
Sponsor's protocol ID
MS700568_0183
Other IDs
2023-507746-83-00, CTR20243857, jRCT2031240175, SNCTP000006603, 2023
Status last verified
Oct 2026
First submitted
11 Jun 2024
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD supporting publicly available results will be evaluated for sharing.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cladribine Low Dose and Cladribine High Dose in people with Generalized Myasthenia Gravis, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 154 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 154 sites in United States, China, Japan, Germany, Argentina and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact US Medical Information (888-275-7376, eMediUSA@emdserono.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06463587.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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