Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)
NCT ID: NCT06463587
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
264 participants
INTERVENTIONAL
2024-06-25
2030-08-19
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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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.
Placebo
Participants will receive placebo matched to cladribine in two courses separated by 4 weeks.
Cladribine Low Dose
Participants will receive cladribine low dose in two courses separated by 4 weeks.
Cladribine High Dose
Participants will receive cladribine high dose in two courses separated by 4 weeks.
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.
Cladribine Low Dose
Participants will receive cladribine low dose in two courses separated by 4 weeks.
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.
Cladribine High Dose
Participants will receive cladribine high dose in two courses separated by 4 weeks.
Interventions
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Placebo
Participants will receive placebo matched to cladribine in two courses separated by 4 weeks.
Cladribine Low Dose
Participants will receive cladribine low dose in two courses separated by 4 weeks.
Cladribine High Dose
Participants will receive cladribine high dose in two courses separated by 4 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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 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. 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)
* Active malignancy, or history of cancer
* Treatment with nonsteroidal immunosuppressants, used in gMG, such as azathioprine, mycophenolate mofetil, methotrexate, cyclosporine, tacrolimus within 4 weeks prior to randomization
* Treatment with eculizumab, rozanolixizumab efgartigimod, ravulizumab, or zilucoplan within 8 weeks prior to randomization
* History of thymectomy within 6 months prior to Screening.
* History of generalized seizures (except for history of infantile febrile seizures)
* Negative 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) within the last 2 years
* 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
* 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
* 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
18 Years
ALL
No
Sponsors
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EMD Serono Research & Development Institute, Inc.
INDUSTRY
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
EMD Serono Research & Development Institute, Inc.
Locations
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Arizona Neuroscience Research, LLC
Phoenix, Arizona, 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
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 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
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
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Box Hill Hospital - PARENT
Box Hill, Victoria, Australia
Gold Coast University Hospital - PARENT
Southport, , Australia
Medical Center Hera - branch Montana
Montana, , Bulgaria
The First Affiliated Hospital of Bengbu Medical College
Anhui Sheng, Anhui, China
Xuanwu Hospital Capital Medical University
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
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 de Grenoble - Hôpital Albert Michallon - Centre de Références des Maladies Neuromusculaires
La Tronche, Isere, France
Hopital Neurologique Pierre Wertheimer - Pathologies neuro-musculaires. Electromyographie
Bron, Rhone, 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
Bangalore Medical College and Victoria Hospital - 300148268
Bangalore, Karnataka, India
Mallikatta Neurocentre
Mangalore, Karnataka, India
IUHW Narita Hospital - Dept of Neurology
Narita-shi, Chiba, 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
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
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii Klinicznej
Krakow, , Poland
Wielospecjalistyczne Centrum Medyczne Ibismed - Dept of Neurology
Zabrze, , Poland
S.C Neurocity S.R.L
Bucharest, , Romania
Spitalul Clinic Judetean de Urgenta Targu Mures - Sectia Clinica Neurologie I
Târgu Mureş, , Romania
Kyungpook National University Chilgok Hospital
Daegu, , South Korea
Chonnam National University Hospital
Gwangju, , 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 Vall d'Hebron - Neurology Dept
Barcelona, , Spain
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
Royal Hallamshire Hospital - Dept of Neurology
Sheffield, South Yorkshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Trial Awareness and Transparency website
US Medical Information website, Medical Resources
Related Info
Other Identifiers
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2023-507746-83-00
Identifier Type: OTHER
Identifier Source: secondary_id
MS700568_0183
Identifier Type: -
Identifier Source: org_study_id