Clinical Trial

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

Recruiting Phase 3
View on ClinicalTrials.gov →
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. 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.
Protocol Amendment History 5 changes
notable Trial sites expanded: 145 -> 148 locations 2026-08-13
notable Trial sites expanded: 138 -> 144 locations 2026-06-26
notable Trial sites expanded: 133 -> 138 locations 2026-05-23
notable Primary completion pushed: 2028-05-19 -> 2028-08-23 2026-05-23
minor Completion pushed: 2030-08-19 -> 2030-11-12 2026-05-23
Trial Details
NCT Number NCT06463587
Lead Sponsor Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Collaborators: EMD Serono Research & Development Institute, Inc.
Conditions Generalized Myasthenia Gravis
Enrollment 264 participants
Start Date 2024-06-25
Primary Completion 2028-08-23 (estimated)
Study Completion 2030-11-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-12