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.
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 Italy