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Study identifier: NCT06463587 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Generalized Myasthenia Gravis  ·  Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

PhasePhase 3
Planned participants264
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

US Medical Information  ·  888-275-7376  ·  eMediUSA@emdserono.com

Communication Center  ·  +49 6151 72 5200  ·  service@emdgroup.com

Always discuss trial participation with your own doctor first.

Locations (145)

Arizona Neuroscience Research, LLCPhoenix, Arizona, United StatesRecruiting
Advanced Neurosciences Research LLCLongmont, Colorado, United StatesActive Not Recruiting
University of Connecticut Health Center - Department of MedicineFarmington, Connecticut, United StatesRecruiting
The George Washington University Medical Faculty Associates Foggy Bottom South PavilionWashington D.C., District of Columbia, United StatesRecruiting
Neurology of Central Florida Research Center, LLCAltamonte Springs, Florida, United StatesRecruiting
SFM Clinical Research, LLCBoca Raton, Florida, United StatesRecruiting
University of Florida Health Science Center - 300120311Jacksonville, Florida, United StatesRecruiting
Neurology Associates, P. A.Maitland, Florida, United StatesRecruiting
University of South Florida - PARENT - PARENTTampa, Florida, United StatesRecruiting
University of Kansas Medical Center Research Institute, Inc. - 3901 Rainbow (MAIN)Kansas City, Kansas, United StatesRecruiting
UNC Hospitals - PARENTChapel Hill, North Carolina, United StatesRecruiting
Atrium Health Wake Forest BaptistWinston-Salem, North Carolina, United StatesRecruiting

+ 133 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06463587