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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany • ClinicalTrials.gov ID: NCT06463587

Registry updated: 2026-09-16
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Description

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.

Interventions

  • Placebo (Other)
    Participants will receive placebo matched to cladribine in two courses separated by 4 weeks.
  • Cladribine Low Dose (Drug)
    Participants will receive cladribine low dose in two courses separated by 4 weeks.
  • Cladribine High Dose (Drug)
    Participants will receive cladribine high dose in two courses separated by 4 weeks.

Eligibility criteria

Inclusion Criteria: * 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. * 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 Exclusion Criteria: * 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 * 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

Conditions

Generalized Myasthenia Gravis

Locations

  • Arizona Neuroscience Research, LLC — Phoenix, Arizona, United States
  • Advanced Neurosciences Research LLC — Longmont, Colorado, United States
  • University of Connecticut Health Center - Department of Medicine — Farmington, Connecticut, United States
  • The George Washington University Medical Faculty Associates Foggy Bottom South Pavilion — Washington D.C., District of Columbia, United States
  • Neurology of Central Florida Research Center, LLC — Altamonte Springs, Florida, United States
  • SFM Clinical Research, LLC — Boca Raton, Florida, United States
  • University of Florida Health Science Center - 300120311 — Jacksonville, Florida, United States
  • Neurology Associates, P. A. — Maitland, Florida, United States
  • University of South Florida - PARENT - PARENT — Tampa, Florida, United States
  • University of Kansas Medical Center Research Institute, Inc. - 3901 Rainbow (MAIN) — Kansas City, Kansas, United States
  • UNC Hospitals - PARENT — Chapel Hill, North Carolina, United States
  • Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States
  • Miami Valley Hospital South — Centerville, Ohio, United States
  • University of Cincinnati — Cincinnati, Ohio, United States
  • Clinical Trials of South Carolina - Charleston — Charleston, South Carolina, United States
  • Erlanger Health, Inc. - 1123255 — Chattanooga, Tennessee, United States
  • Baylor Scott & White Research Institute - Baylor Scott & White Research Institute — Dallas, Texas, United States
  • ANESC Research — El Paso, Texas, United States
  • Baylor Scott & White Neurology - McKinney — McKinney, Texas, United States
  • The University of Vermont Medical Center — Burlington, Vermont, United States
  • Integrated Neurology Services - Dr. Simon Fishman's Office — Falls Church, Virginia, United States
  • Expertia S.A- Mautalen Salud e Investigación — Ciudad Autonoma Buenos Aires, Argentina
  • Instituto de Investigaciones Neurologicas Raul Carrea, FLENI - de Investigaciones Clinicas del área de Cardiología y enfermedades metabólicas asociadas — Ciudad Autonoma Buenos Aires, Argentina
  • Instituto de Investigaciones Metabolicas (IDIM) — Ciudad Autonoma Buenos Aires, Argentina
  • Hospital Cordoba — Córdoba, Argentina
  • Fundacion Rosarina de Neurorehabilitacion — Rosario, Argentina
  • INECO Neurociencias Oroño — Rosario, Argentina
  • CER San Juan Centro Polivalente de Asistencia e Inv. Clinica — San Juan, Argentina
  • Centro de Investigaciones Medicas Tucuman — San Miguel de Tucumán, Argentina
  • Brain and Mind Research Institute — Camperdown, New South Wales, Australia
  • Sunshine Coast University Hospital — Birtinya, Queensland, Australia
  • Princess Alexandra Hospital - PARENT — South Brisbane, Queensland, Australia
  • John Hunter Hospital - PARENT — City of Burnside, South Australia, Australia
  • Box Hill Hospital - PARENT — Box Hill, Victoria, Australia
  • Gold Coast University Hospital - PARENT — Southport, Australia
  • UZ Leuven — Leuven, Belgium
  • C. H. R. de la Citadelle - Account 1 — Liège, Belgium
  • Medical Center Hera - branch Montana — Montana, Bulgaria
  • UMHAT 'Dr. Georgi Stranski', EAD — Pleven, Bulgaria
  • UMHAT "Sv. Georgi", EAD — Plovdiv, Bulgaria
  • MHATNP "Sv.Naum", EAD - Third Neurology Clinic — Sofia, Bulgaria
  • UMHATEM 'N.I. Pirogov', EAD — Sofia, Bulgaria
  • Burnaby Hospital - Fraser Health Multiple Sclerosis Clinic — Burnaby, British Columbia, Canada
  • The First Affiliated Hospital of Bengbu Medical College — Anhui Sheng, Anhui, China
  • Xuanwu Hospital Capital Medical University — Beijing, Beijing Municipality, China
  • Peking Union Medical College Hospital — Beijing, Beijing Municipality, China
  • The First Affiliated Hospital of Guangzhou University of Chinese Medicine - 300164595 — Guangzhou, Guangdong, China
  • Affiliated Hospital of Zunyi Medical University — Zunyi, Guizhou, China
  • Shijiazhuang People's Hospital — Shijiazhuang, Hebei, China
  • Henan Provincial People's Hospital — Zhengzhou, Henan, China
  • Xiangya Hospital, Central South University — Changsha, Hu'nan, China
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology — Wuhan, Hubei, China
  • The First Hospital of Jilin University - The First Hospital of Jilin University — Changchun, Jilin, China
  • China-Japan Union Hospital of Jilin University - 300173736 — Changchun, Jilin, China
  • Shengjing Hospital of China Medical University — Shenyang, Liaoning, China
  • Huashan Hospital, Fudan University - Neurology — Shanghai, Shanghai Municipality, China
  • Xi 'an International Medical Center — Xi’an, Shanxi, China
  • West China Hospital, Sichuan University — Chengdu, Sichuan, China
  • CHU Nice - Hôpital Pasteur - Cardiology — Nice, Alpes Maritimes, France
  • CHU Strasbourg - Hopital Hautepierre - Service Anesthesie-Reanimation&Medecine Peri-Opera — Strasbourg, Bas Rhin, France
  • CHU de Grenoble - Hôpital Albert Michallon - Centre de Références des Maladies Neuromusculaires — La Tronche, Isere, France
  • Fondation Ophtalmologique Adolphe de Rothschild - Service de neurologie — Paris, Paris, France
  • CHU Clermont Ferrand - Hopital Gabriel Montpied - service de neurologie B — Clermont-Ferrand, Puy De Dome, France
  • Hopital Neurologique Pierre Wertheimer - Pathologies neuro-musculaires. Electromyographie — Bron, Rhone, France
  • Hôpital Henri Mondor - Service de Neurologie — Créteil, Val De Marne, France
  • Groupe Hospitalier Pitie-Salpetriere - Centre Référent Maladies Rares SLA - Neurologie — Paris, France
  • Ltd. Pineo Medical Ecosystem — Tbilisi, Georgia
  • New Hospitals LLC — Tbilisi, Georgia
  • Aversi Clinic Ltd — Tbilisi, Georgia
  • Universitaetsklinikum Ulm - Klinik fuer Neurologie — Ulm, Baden-Wurttemberg, Germany
  • Universitaetsmedizin Goettingen - Abteilung fuer Nephrologie und Rheumatologie — Göttingen, Lower Saxony, Germany
  • Medizinische Hochschule Hannover - Klinik fur Neurologie mit Klinischer Neurophysiol — Hanover, Lower Saxony, Germany
  • St. Joseph Hospital - St. Joseph Hospital Haan — Bochum, North Rhine-Westphalia, Germany
  • Universitaetsklinikum Duesseldorf AoeR - Klinik fuer Neurologie — Düsseldorf, North Rhine-Westphalia, Germany
  • Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I — Dresden, Saxony, Germany
  • Universitaetsklinikum Leipzig AoeR - Klinik und Poliklinik fuer Neurologie — Leipzig, Saxony, Germany
  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck - Neurologie — Lübeck, Schleswig-Holstein, Germany
  • Charité Universitaetsmedizin Berlin - Campus Charité Mitte - Klinik fuer Neurologie — Berlin, Germany
  • University General Hospital of Larissa - Rheumatology Clinic — Larissa, Greece
  • University Hospital of Patra — Pátrai, Greece
  • AHEPA General Hospital of Thessaloniki — Thessaloniki, Greece
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont - Neurologiai Klinika — Szeged, Hungary
  • Nizam's Institute of Medical Sciences — Hyderabad, Andhra Pradesh, India
  • Yashoda Super Speciality Hospital - 300158817 — Hyderabad, Andhra Pradesh, India
  • Bangalore Medical College and Victoria Hospital - 300148268 — Bangalore, Karnataka, India
  • St John's Medical College Hospital — Bangalore, Karnataka, India
  • Mallikatta Neurocentre — Mangalore, Karnataka, India
  • Chopda Medicare & Research Centre - 300188248 — Nashik, Maharashtra, India
  • Deenanath Mangeshkar Hospital and Research Centre - Department of Neurology — Pune, Maharashtra, India
  • Azienda Socio Sanitaria Territoriale Papa Giovanni — Bergamo, Italy
  • IRCCS Istituto delle Scienze Neurologiche di Bologna - Unità Operativa Complessa Clinica Neurologica — Bologna, Italy
  • IRCCS Ospedale Policlinico San Martino - Neuroradiologia — Genova, Italy
  • Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan, Italy
  • Fondazione Istituto Neurologico Casimiro Mondino - Neurology — Pavia, Italy
  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata - U.O.C. Neurologia — Rome, Italy
  • Policlinico Universitario Agostino Gemelli - UOC Neurologia — Rome, Italy
  • Ospedale ca' Foncello - Neurology — Treviso, Italy
  • Chiba University Hospital - Dept of Neurology — Chiba, Chiba, Japan
  • IUHW Narita Hospital - Dept of Neurology — Narita-shi, Chiba, Japan
  • Fukuoka University Hospital - Dept of Neurology/Health Care — Fukuoka, Fukuoka, Japan
  • Southern Tohoku Medical Clinic - Dept of Neurology — Koriyama-shi, Fukushima, Japan
  • Hakodate Municipal Hospital - Dept of Neurology — Hakodate-shi, Hokkaido, Japan
  • General Hanamaki Hospital - Dept of Neurology — Hanamaki-shi, Iwate, Japan
  • Kagawa University Hospital - Dept of Neurology — Kita-gun, Kagawa-ken, Japan
  • Nagasaki University Hospital - Dept of Neurology — Nagasaki, Nagasaki, Japan
  • Saitama Medical University Hospital - Dept of Neurology/Stroke Care Unit — Iruma-gun, Saitama, Japan
  • Toho University Ohashi Medical Center - Dept of Neurology — Meguro-ku, Tokyo-To, Japan
  • Tokyo Medical University Hospital - Dept of Neurology — Shinjuku-ku, Tokyo-To, Japan
  • Osaka University Hospital - Dept of Neurology/Stroke Care Unit — Suita-shi, Japan
  • Uniwersyteckie Centrum Kliniczne - Dept of Neurology — Gdansk, Poland
  • SP ZOZ Szpital Uniwersytecki w Krakowie - Zespó — Krakow, Poland
  • Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii Klinicznej — Krakow, Poland
  • MTZ Clinical Research Powered By Pratia — Warsaw, Poland
  • Wielospecjalistyczne Centrum Medyczne Ibismed - Dept of Neurology — Zabrze, Poland
  • Institutul Clinic Fundeni - parent — Bucharest, Romania
  • S.C Neurocity S.R.L — Bucharest, Romania
  • Brainaxy Clinic S.R.L. — Constanța, Romania
  • Spitalul Clinic Judetean de Urgenta Targu Mures - Sectia Clinica Neurologie I — Târgu Mureş, Romania
  • University Clinical Center of Serbia - Clinic of Neurology — Belgrade, Serbia
  • University Clinical Center Kragujevac - Department of Neurology — Kragujevac, Serbia
  • University Clinical Center Nis - Parent — Niš, Serbia
  • Clinical Center of Vojvodina - Department of Neurology — Novi Sad, Serbia
  • Kyungpook National University Chilgok Hospital — Daegu, South Korea
  • Chonnam National University Hospital — Gwangju, South Korea
  • Severance Hospital, Yonsei University Health System - Division of Infectious Diseases — Seoul, South Korea
  • Samsung Medical Center — Seoul, South Korea
  • Korea University Anam Hospital — Seoul, South Korea
  • Asan Medical Center — Seoul, South Korea
  • Seoul Metropolitan Government Seoul National University Boramae Medical Center — Seoul, South Korea
  • Keimyung University Dongsan Hospital — Seoul, South Korea
  • Hospital Universitari Germans Trias i Pujol - Servicio de Neurologia — Badalona, Barcelona, Spain
  • Hospital Universitario Reina Sofia - Neurology Dept — Córdoba, Córdoba, Spain
  • Hospital Universitario Central de Asturias - Servicio de Neurologia — Oviedo, Principality of Asturias, Spain
  • Hospital Universitari Vall d'Hebron - Neurology Dept — Barcelona, Spain
  • Hospital Universitari i Politecnic La Fe - Pediatry Department — Valencia, Spain
  • Sahlgrenska Sjukhuset — Göteborg, Sweden
  • Centralsjukhuset Karlstad — Karlstad, Sweden
  • Danderyd Sjukhus - 300147691 — Stockholm, Sweden
  • Inselspital - Universitaetsspital Bern - Neuropsychologische Rehabilitation, Neurologie — Bern, Switzerland
  • Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City, Taiwan
  • China Medical University Hospital — Taichung, Taiwan
  • Shin Kong Wu Ho-Su Memorial Hospital — Taipei, Taiwan
  • Taipei Veterans General Hospital — Taipei, Taiwan
  • Hacettepe University Medical Faculty - Neurology Department — Ankara, Turkey (Türkiye)
  • Ondokuz Mayis Univ. Med. Fac. - Neurology — Atakum/SAMSUN, Turkey (Türkiye)
  • Istanbul University Istanbul Medical Faculty - Neurology — Istanbul, Turkey (Türkiye)
  • Dokuz Eylul University Faculty of Medicine - Neurology Department — Izmir, Turkey (Türkiye)
  • Kocaeli University Medical Faculty - Neurology Department — Kocaeli, Turkey (Türkiye)
  • Mersin University Medical Faculty - Neurology Department — Mersin, Turkey (Türkiye)
  • Karadeniz Tecnical Uni. Med. Fac. - Neurology Departmen — Trabzon, Turkey (Türkiye)
  • Queen Square Centre for Neuromuscular Diseases — London, Greater London, United Kingdom
  • Nottingham University Hospitals NHS Trust — Nottingham, Nottinghamshire, United Kingdom
  • Royal Hallamshire Hospital - Dept of Neurology — Sheffield, South Yorkshire, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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