A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm, 3-Period Study to Assess the Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)

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.

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Other
  Placebo

  Participants will receive placebo matched to cladribine in two courses separated by 4 weeks.

• Drug
  Cladribine Low Dose

  Participants will receive cladribine low dose in two courses separated by 4 weeks.

• Drug
  Cladribine High Dose

  Participants will receive cladribine high dose in two courses separated by 4 weeks.

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