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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
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507746-83-00
Acronym
MS700568_0183
Enrollment
69
Registered
2024-10-09
Start date
2024-11-27
Completion date
Unknown
Last updated
2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Myasthenia Gravis

Brief summary

Change from Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Scale Score at Week 24 During the Double-Blind Placebo Controlled (DBPC) Period.

Detailed description

Change from Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score at Week 24 during the Double-Blind Placebo Controlled (DBPC) Period., Percentage of MG-ADL Responders at Week 24 during the Double-Blind Placebo Controlled (DBPC) Period., Change from Baseline in Myasthenia Gravis Composite (MGC) Scale Score at Week 24 during the Double-Blind Placebo Controlled (DBPC) Period., Percentage of Quantitative Myasthenia Gravis (QMG) Scale Responders at Week 24 during the Double-Blind Placebo Controlled (DBPC) Period., Change from Baseline in the Revised Myasthenia Gravis Quality of Life – 15 Scale (MG-Qol15r) Score at Week 24 during the Double-Blind Placebo Controlled (DBPC) Period., Time From Initial Cladribine Full Dose Treatment to First Retreatment of Rescue Treatment up to end of Study., Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)., Number of participants with Adverse Events (AEs) by Severity as per National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0., Number of Participants with Abnormal Laboratory Variables including Absolute Lymphocyte Count and Vital Signs., Pharmacokinetic (PK) Plasma Concentrations of Cladribine.

Interventions

Sponsors

Merck Healthcare KGaA
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Scale Score at Week 24 During the Double-Blind Placebo Controlled (DBPC) Period.

Secondary

MeasureTime frame
Change from Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score at Week 24 during the Double-Blind Placebo Controlled (DBPC) Period., Percentage of MG-ADL Responders at Week 24 during the Double-Blind Placebo Controlled (DBPC) Period., Change from Baseline in Myasthenia Gravis Composite (MGC) Scale Score at Week 24 during the Double-Blind Placebo Controlled (DBPC) Period., Percentage of Quantitative Myasthenia Gravis (QMG) Scale Responders at Week 24 during the Double-Blind Placebo Controlled (DBPC) Period., Change from Baseline in the Revised Myasthenia Gravis Quality of Life – 15 Scale (MG-Qol15r) Score at Week 24 during the Double-Blind Placebo Controlled (DBPC) Period., Time From Initial Cladribine Full Dose Treatment to First Retreatment of Rescue Treatment up to end of Study., Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)., Number of participants with Adverse Events (AEs) by Severity as per National Cancer Institute Commo

Countries

Belgium, Bulgaria, Czechia, France, Germany, Greece, Hungary, Italy, Poland, Romania, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026