Actively Recruiting
Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)
Led by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Updated on 2026-04-22
264
Participants Needed
133
Research Sites
320 weeks
Total Duration
On this page
Sponsors
M
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Lead Sponsor
E
EMD Serono Research & Development Institute, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults of 63 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.
- Positive for Acetylcholine receptor antibody (anti-AChR) or muscle-specific kinase antibody(anti-MuSK), or seronegative and positive for anti-low-density lipoprotein receptor-related protein 4 antibodies (anti-LRP4).
- Screening and Baseline MG-ADL score 63 6 with 63 50% of the total score due to non-ocular symptoms.
- Stable Screening and Baseline MG-ADL scores with a difference not more than 2 and no reported MG exacerbation during Screening.
- Stable daily dose of oral corticosteroids for at least 3 months prior to and during screening, not exceeding 20 mg/day prednisone/prednisolone or 16 mg/day methylprednisolone.
- Stable daily dose of acetylcholinesterase inhibitor (pyridostigmine 64 480 mg/day) for at least 3 months prior to and during screening.
- Body weight 63 40 kilograms.
- Other protocol defined inclusion criteria could apply
You will not qualify if you...
- Immunologic disorder other than MG or any other condition requiring chronic corticosteroid therapy (except well-controlled thyroid disease).
- Molecularly characterized or suspected congenital myasthenic syndrome, Lambert-Eaton myasthenic syndrome, inherited myopathy, muscular dystrophy, acquired myopathy or other neurologic/systemic diseases mimicking MG.
- Active, clinically significant viral, bacterial, or fungal infection, or recent major infection requiring hospitalization or parenteral treatment within 8 weeks prior/during Screening.
- History or current diagnosis of active tuberculosis.
- Active malignancy or history of cancer.
- Treatment with nonsteroidal immunosuppressants used in gMG 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 infantile febrile seizures).
- Negative for Varicella Zoster Virus antibodies at screening.
- History of myasthenic crisis in last 12 months prior to/during screening.
- History of recurrent infections (3 or more per year) within last 2 years.
- Discontinuation of non-steroidal immunosuppressants used in gMG within last 6 months prior to Screening.
- If treated with non-steroidal immunosuppressants, dose at Screening should not exceed specific limits.
- Participation in investigational drug studies within 6 months or 5 half-lives prior to randomization; prior cladribine exposure excludes participation.
- Other protocol defined exclusion criteria could apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 133 locations
1
Arizona Neuroscience Research, LLC
Phoenix, Arizona, United States, 85032
Actively Recruiting
2
Advanced Neurosciences Research LLC
Longmont, Colorado, United States, 80501
Actively Recruiting
3
The George Washington University Medical Faculty Associates Foggy Bottom South Pavilion
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
4
Neurology of Central Florida Research Center, LLC
Altamonte Springs, Florida, United States, 32714
Actively Recruiting
5
SFM Clinical Research, LLC
Boca Raton, Florida, United States, 33487
Actively Recruiting
6
University of Florida Health Science Center - 300120311
Jacksonville, Florida, United States, 32209
Actively Recruiting
7
Neurology Associates, P. A.
Maitland, Florida, United States, 32751
Actively Recruiting
8
University of South Florida - PARENT - PARENT
Tampa, Florida, United States, 33612
Actively Recruiting
9
University of Kansas Medical Center Research Institute, Inc. - 3901 Rainbow (MAIN)
Kansas City, Kansas, United States, 66160
Actively Recruiting
10
UNC Hospitals - PARENT
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
11
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States, 27157-1078
Actively Recruiting
12
Miami Valley Hospital South
Centerville, Ohio, United States, 45459
Actively Recruiting
13
Clinical Trials of South Carolina - Charleston
Charleston, South Carolina, United States, 29406
Actively Recruiting
14
Erlanger Health, Inc. - 1123255
Chattanooga, Tennessee, United States, 37403
Actively Recruiting
15
Baylor Scott & White Research Institute - Baylor Scott & White Research Institute
Dallas, Texas, United States, 75246
Actively Recruiting
16
ANESC Research
El Paso, Texas, United States, 79912
Actively Recruiting
17
Baylor Scott & White Neurology - McKinney
McKinney, Texas, United States, 75071
Actively Recruiting
18
The University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Actively Recruiting
19
Integrated Neurology Services - Dr. Simon Fishman's Office
Falls Church, Virginia, United States, 22043
Actively Recruiting
20
Expertia S.A- Mautalen Salud e Investigación
Ciudad Autonoma Buenos Aires, Argentina, 1427
Actively Recruiting
21
Instituto de Investigaciones Neurologicas Raul Carrea, FLENI - de Investigaciones Clinicas del área de Cardiología y enfermedades metabólicas asociadas
Ciudad Autonoma Buenos Aires, Argentina, 1428
Actively Recruiting
22
Instituto de Investigaciones Metabolicas (IDIM)
Ciudad Autonoma Buenos Aires, Argentina, C1012AAR
Actively Recruiting
23
Hospital Cordoba
Córdoba, Argentina
Actively Recruiting
24
Fundacion Rosarina de Neurorehabilitacion
Rosario, Argentina
Actively Recruiting
25
INECO Neurociencias Oroño
Rosario, Argentina
Actively Recruiting
26
CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
San Juan, Argentina, 5400
Actively Recruiting
27
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, Argentina
Actively Recruiting
28
Sunshine Coast University Hospital
Birtinya, Queensland, Australia, 4575
Actively Recruiting
29
John Hunter Hospital - PARENT
City of Burnside, South Australia, Australia, SA 5072
Actively Recruiting
30
Box Hill Hospital - PARENT
Box Hill, Victoria, Australia, 3128
Actively Recruiting
31
Gold Coast University Hospital - PARENT
Southport, Australia
Actively Recruiting
32
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
33
C. H. R. de la Citadelle - Account 1
Liège, Belgium, 4000
Actively Recruiting
34
Medical Center Hera - branch Montana
Montana, Bulgaria, 3400
Actively Recruiting
35
UMHAT 'Dr. Georgi Stranski', EAD
Pleven, Bulgaria, 5800
Actively Recruiting
36
UMHAT "Sv. Georgi", EAD
Plovdiv, Bulgaria, 4000
Actively Recruiting
37
MHATNP "Sv.Naum", EAD - Third Neurology Clinic
Sofia, Bulgaria, 1113
Actively Recruiting
38
UMHATEM 'N.I. Pirogov', EAD
Sofia, Bulgaria, 1606
Actively Recruiting
39
The First Affiliated Hospital of Bengbu Medical College
Anhui Sheng, Anhui, China, 233000
Actively Recruiting
40
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China, 100053
Actively Recruiting
41
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
42
The First Affiliated Hospital of Guangzhou University of Chinese Medicine - 300164595
Guangzhou, Guangdong, China, 510405
Actively Recruiting
43
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China, 563099
Actively Recruiting
44
Shijiazhuang People's Hospital
Shijiazhuang, Hebei, China, 050000
Actively Recruiting
45
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
46
Xiangya Hospital, Central South University
Changsha, Hu'nan, China, 410008
Actively Recruiting
47
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
48
The First Hospital of Jilin University - The First Hospital of Jilin University
Changchun, Jilin, China, 130021
Actively Recruiting
49
China-Japan Union Hospital of Jilin University - 300173736
Changchun, Jilin, China, 130033
Actively Recruiting
50
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110004
Actively Recruiting
51
Huashan Hospital, Fudan University - Neurology
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
52
Xi 'an International Medical Center
Xi’an, Shanxi, China, 710038
Actively Recruiting
53
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
54
CHU Nice - Hôpital Pasteur - Cardiology
Nice, Alpes Maritimes, France, 06002
Actively Recruiting
55
CHU Strasbourg - Hopital Hautepierre - Service Anesthesie-Reanimation&Medecine Peri-Opera
Strasbourg, Bas Rhin, France, 67098
Actively Recruiting
56
CHU de Grenoble - Hôpital Albert Michallon - Centre de Références des Maladies Neuromusculaires
La Tronche, Isere, France, 38700
Actively Recruiting
57
Fondation Ophtalmologique Adolphe de Rothschild - Service de neurologie
Paris, Paris, France, 75940
Actively Recruiting
58
CHU Clermont Ferrand - Hopital Gabriel Montpied - service de neurologie B
Clermont-Ferrand, Puy De Dome, France, 63003
Actively Recruiting
59
Hopital Neurologique Pierre Wertheimer - Pathologies neuro-musculaires. Electromyographie
Bron, Rhone, France, 69677
Actively Recruiting
60
Hôpital Henri Mondor - Service de Neurologie
Créteil, Val De Marne, France, 94010
Actively Recruiting
61
Groupe Hospitalier Pitie-Salpetriere - Centre Référent Maladies Rares SLA - Neurologie
Paris, France, 75013
Actively Recruiting
62
Ltd. Pineo Medical Ecosystem
Tbilisi, Georgia, 0114
Actively Recruiting
63
New Hospitals LLC
Tbilisi, Georgia, 0114
Actively Recruiting
64
Aversi Clinic Ltd
Tbilisi, Georgia, 0160
Actively Recruiting
65
Universitaetsmedizin Goettingen - Abteilung fuer Nephrologie und Rheumatologie
Göttingen, Lower Saxony, Germany, 37075
Actively Recruiting
66
Medizinische Hochschule Hannover - Klinik fur Neurologie mit Klinischer Neurophysiol
Hanover, Lower Saxony, Germany, 30625
Actively Recruiting
67
St. Joseph Hospital - St. Joseph Hospital Haan
Bochum, North Rhine-Westphalia, Germany, 44791
Actively Recruiting
68
Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I
Dresden, Saxony, Germany, 01307
Actively Recruiting
69
Universitaetsklinikum Leipzig AoeR - Klinik und Poliklinik fuer Neurologie
Leipzig, Saxony, Germany, 04103
Actively Recruiting
70
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck - Neurologie
Lübeck, Schleswig-Holstein, Germany, 23562
Actively Recruiting
71
Charité Universitaetsmedizin Berlin - Campus Charité Mitte - Klinik fuer Neurologie
Berlin, Germany, 10117
Actively Recruiting
72
University General Hospital of Larissa - Rheumatology Clinic
Larissa, Greece, 41500
Actively Recruiting
73
University Hospital of Patra
Pátrai, Greece, 26504
Actively Recruiting
74
AHEPA General Hospital of Thessaloniki
Thessaloniki, Greece, 54636
Actively Recruiting
75
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont - Neurologiai Klinika
Szeged, Hungary, 6725
Actively Recruiting
76
Nizam's Institute of Medical Sciences
Hyderabad, Andhra Pradesh, India, 500082
Actively Recruiting
77
Yashoda Super Speciality Hospital - 300158817
Hyderabad, Andhra Pradesh, India, 500082
Actively Recruiting
78
Bangalore Medical College and Victoria Hospital - 300148268
Bangalore, Karnataka, India, 560002
Actively Recruiting
79
St John's Medical College Hospital
Bangalore, Karnataka, India, 560034
Actively Recruiting
80
Mallikatta Neurocentre
Mangalore, Karnataka, India, 575001
Actively Recruiting
81
Chopda Medicare & Research Centre - 300188248
Nashik, Maharashtra, India, 422005
Actively Recruiting
82
Deenanath Mangeshkar Hospital and Research Centre - Department of Neurology
Pune, Maharashtra, India, 411030
Actively Recruiting
83
Policlinico Universitario Agostino Gemelli - UOC Neurologia
Rome, Roma, Italy, 00168
Actively Recruiting
84
Azienda Socio Sanitaria Territoriale Papa Giovanni
Bergamo, Italy, 24127
Actively Recruiting
85
IRCCS Istituto delle Scienze Neurologiche di Bologna - Unità Operativa Complessa Clinica Neurologica
Bologna, Italy, 40139
Actively Recruiting
86
IRCCS Ospedale Policlinico San Martino - Neuroradiologia
Genova, Italy, 16132
Actively Recruiting
87
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy, 20133
Actively Recruiting
88
Fondazione Istituto Neurologico Casimiro Mondino - Neurology
Pavia, Italy, 27100
Actively Recruiting
89
Azienda Ospedaliera Universitaria Policlinico Tor Vergata - U.O.C. Neurologia
Roma, Italy, 00133
Actively Recruiting
90
Ospedale ca' Foncello - Neurology
Treviso, Italy, 31100
Actively Recruiting
91
Chiba University Hospital - Dept of Neurology
Chiba, Chiba, Japan, 260-8677
Actively Recruiting
92
IUHW Narita Hospital - Dept of Neurology
Narita-shi, Chiba, Japan, 286-8520
Actively Recruiting
93
Fukuoka University Hospital - Dept of Neurology/Health Care
Fukuoka, Fukuoka, Japan, 814-0180
Actively Recruiting
94
Southern Tohoku Medical Clinic - Dept of Neurology
Koriyama-shi, Fukushima, Japan, 963-8563
Actively Recruiting
95
Hakodate Municipal Hospital - Dept of Neurology
Hakodate-shi, Hokkaido, Japan, 392006
Actively Recruiting
96
General Hanamaki Hospital - Dept of Neurology
Hanamaki-shi, Iwate, Japan, 025-0082
Actively Recruiting
97
Kagawa University Hospital - Dept of Neurology
Kita-gun, Kagawa-ken, Japan, 7610793
Actively Recruiting
98
Nagasaki University Hospital - Dept of Neurology
Nagasaki, Nagasaki, Japan, 852-8501
Actively Recruiting
99
Saitama Medical University Hospital - Dept of Neurology/Stroke Care Unit
Iruma-gun, Saitama, Japan, 350-0495
Actively Recruiting
100
Toho University Ohashi Medical Center - Dept of Neurology
Meguro-ku, Tokyo-To, Japan, 153-8515
Actively Recruiting
101
Tokyo Medical University Hospital - Dept of Neurology
Shinjuku-ku, Tokyo-To, Japan, 160-0023
Actively Recruiting
102
Osaka University Hospital - Dept of Neurology/Stroke Care Unit
Suita-shi, Japan
Actively Recruiting
103
Uniwersyteckie Centrum Kliniczne - Dept of Neurology
Gdansk, Poland, 80-214
Actively Recruiting
104
SP ZOZ Szpital Uniwersytecki w Krakowie - Zespó
Krakow, Poland, 30-688
Actively Recruiting
105
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii Klinicznej
Krakow, Poland, 31-505
Actively Recruiting
106
MTZ Clinical Research Powered By Pratia
Warsaw, Poland, 02-091
Actively Recruiting
107
Wielospecjalistyczne Centrum Medyczne Ibismed - Dept of Neurology
Zabrze, Poland
Actively Recruiting
108
Institutul Clinic Fundeni - parent
Bucharest, Romania, 022328
Actively Recruiting
109
S.C Neurocity S.R.L
Bucharest, Romania, 040215
Actively Recruiting
110
Brainaxy Clinic S.R.L.
Constanța, Romania, 900591
Actively Recruiting
111
Spitalul Clinic Judetean de Urgenta Targu Mures - Sectia Clinica Neurologie I
Târgu Mureş, Romania, 540136
Actively Recruiting
112
Kyungpook National University Chilgok Hospital
Daegu, South Korea, 41404
Actively Recruiting
113
Chonnam National University Hospital
Gwangju, South Korea, 61469
Actively Recruiting
114
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
115
Korea University Anam Hospital
Seoul, South Korea, 136-705
Actively Recruiting
116
Asan Medical Center
Seoul, South Korea, 138-736
Actively Recruiting
117
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, South Korea, 156707
Actively Recruiting
118
Keimyung University Dongsan Hospital
Seoul, South Korea
Withdrawn
119
Hospital Universitari Germans Trias i Pujol - Servicio de Neurologia
Badalona, Barcelona, Spain, 08916
Actively Recruiting
120
Hospital Universitario Reina Sofia - Neurology Dept
Córdoba, Córdoba, Spain, 14004
Actively Recruiting
121
Hospital Universitario Central de Asturias - Servicio de Neurologia
Oviedo, Principality of Asturias, Spain, 33011
Actively Recruiting
122
Hospital Universitari Vall d'Hebron - Neurology Dept
Barcelona, Spain, 08035
Actively Recruiting
123
Hospital Universitari i Politecnic La Fe - Pediatry Department
Valencia, Spain, 46026
Actively Recruiting
124
Sahlgrenska Sjukhuset
Göteborg, Sweden, 41345
Actively Recruiting
125
Centralsjukhuset Karlstad
Karlstad, Sweden, 65230
Actively Recruiting
126
Danderyd Sjukhus - 300147691
Stockholm, Sweden, 18288
Actively Recruiting
127
Inselspital - Universitaetsspital Bern - Neuropsychologische Rehabilitation, Neurologie
Bern, Switzerland, 3010
Actively Recruiting
128
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 83301
Actively Recruiting
129
China Medical University Hospital
Taichung, Taiwan, 404327
Actively Recruiting
130
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan, 111
Actively Recruiting
131
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
132
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Actively Recruiting
133
Royal Hallamshire Hospital - Dept of Neurology
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Actively Recruiting
Research Team
U
US Medical Information
CONTACT
C
Communication Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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