Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)
Condition(s) studied
Investigational drug(s) / intervention(s)
Placebo: Participants will receive placebo matched to cladribine in two courses separated by 4 weeks.
Cladribine Low Dose: Participants will receive cladribine low dose in two courses separated by 4 weeks.
Cladribine High Dose: Participants will receive cladribine high dose in two courses separated by 4 weeks.
Study 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.
Eligibility
Primary outcome measure(s)
- 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 — Baseline, Week 24
Trial sites (153)
| Facility | City | Region | Status |
|---|---|---|---|
| Arizona Neuroscience Research, LLC | Phoenix | Arizona | Recruiting |
| Advanced Neurosciences Research LLC | Longmont | Colorado | Active Not Recruiting |
| University of Connecticut Health Center - Department of Medicine | Farmington | Connecticut | Recruiting |
| The George Washington University Medical Faculty Associates Foggy Bottom South Pavilion | Washington D.C. | District of Columbia | Recruiting |
| Neurology of Central Florida Research Center, LLC | Altamonte Springs | Florida | Recruiting |
| SFM Clinical Research, LLC | Boca Raton | Florida | Recruiting |
| University of Florida Health Science Center - 300120311 | Jacksonville | Florida | Recruiting |
| Neurology Associates, P. A. | Maitland | Florida | Recruiting |
| University of South Florida - PARENT - PARENT | Tampa | Florida | Recruiting |
| University of Kansas Medical Center Research Institute, Inc. - 3901 Rainbow (MAIN) | Kansas City | Kansas | Recruiting |
| UNC Hospitals - PARENT | Chapel Hill | North Carolina | Recruiting |
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | Recruiting |
| Miami Valley Hospital South | Centerville | Ohio | Recruiting |
| University of Cincinnati | Cincinnati | Ohio | Recruiting |
| Clinical Trials of South Carolina - Charleston | Charleston | South Carolina | Recruiting |
| Erlanger Health, Inc. - 1123255 | Chattanooga | Tennessee | Recruiting |
| Baylor Scott & White Research Institute - Baylor Scott & White Research Institute | Dallas | Texas | Recruiting |
| ANESC Research | El Paso | Texas | Recruiting |
| Baylor Scott & White Neurology - McKinney | McKinney | Texas | Recruiting |
| The University of Vermont Medical Center | Burlington | Vermont | Recruiting |
| Integrated Neurology Services - Dr. Simon Fishman's Office | Falls Church | Virginia | Active Not Recruiting |
| Expertia S.A- Mautalen Salud e Investigación | Ciudad Autonoma Buenos Aires | Argentina | Recruiting |
| Instituto de Investigaciones Neurologicas Raul Carrea, FLENI - de Investigaciones Clinicas del área de Cardiología y enfermedades metabólicas asociadas | Ciudad Autonoma Buenos Aires | Argentina | Recruiting |
| Instituto de Investigaciones Metabolicas (IDIM) | Ciudad Autonoma Buenos Aires | Argentina | Recruiting |
| Hospital Cordoba | Córdoba | Argentina | Recruiting |
| Fundacion Rosarina de Neurorehabilitacion | Rosario | Argentina | Recruiting |
| INECO Neurociencias Oroño | Rosario | Argentina | Recruiting |
| CER San Juan Centro Polivalente de Asistencia e Inv. Clinica | San Juan | Argentina | Recruiting |
| Centro de Investigaciones Medicas Tucuman | San Miguel de Tucumán | Argentina | Recruiting |
| Brain and Mind Research Institute | Camperdown | New South Wales | Recruiting |
| Sunshine Coast University Hospital | Birtinya | Queensland | Recruiting |
| Princess Alexandra Hospital - PARENT | South Brisbane | Queensland | Recruiting |
| John Hunter Hospital - PARENT | City of Burnside | South Australia | Recruiting |
| Box Hill Hospital - PARENT | Box Hill | Victoria | Recruiting |
| Gold Coast University Hospital - PARENT | Southport | Australia | Recruiting |
| UZ Leuven | Leuven | Belgium | Recruiting |
| C. H. R. de la Citadelle - Account 1 | Liège | Belgium | Recruiting |
| Medical Center Hera - branch Montana | Montana | Bulgaria | Recruiting |
| UMHAT 'Dr. Georgi Stranski', EAD | Pleven | Bulgaria | Recruiting |
| UMHAT "Sv. Georgi", EAD | Plovdiv | Bulgaria | Recruiting |
+ 113 more sites — see the full list on the official registry below.
More Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany trials in Australia
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06463587 on ClinicalTrials.gov ↗ ← All trials in Australia