NCT06463587

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

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 264 (estimated)
• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Generalized Myasthenia Gravis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-25
• Primary completion: 2028-05-19
• Completion: 2030-08-19
• First posted: 2024-06-18
• Last updated: 2026-03-19

Locations

132 sites across 22 countries: United States, Argentina, Australia, Belgium, Bulgaria, China, France, Georgia, Germany, Greece, Hungary, India, Italy, Japan, Poland, Romania, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study