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

PHASE3RecruitingINTERVENTIONAL
Enrollment

264

Participants

Timeline

Start Date

June 25, 2024

Primary Completion Date

May 19, 2028

Study Completion Date

August 19, 2030

Conditions
Generalized Myasthenia Gravis
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.

Trial Locations (35)

111

RECRUITING

Shin Kong Wu Ho-Su Memorial Hospital, Taipei

1427

RECRUITING

Expertia S.A- Mautalen Salud e Investigación, Ciudad Autonoma Buenos Aires

1428

RECRUITING

Instituto de Investigaciones Neurologicas Raul Carrea, FLENI - de Investigaciones Clinicas del área de Cardiología y enfermedades metabólicas asociadas, Ciudad Autonoma Buenos Aires

5400

RECRUITING

CER San Juan Centro Polivalente de Asistencia e Inv. Clinica, San Juan

11217

RECRUITING

Taipei Veterans General Hospital, Taipei

29406

RECRUITING

Clinical Trials of South Carolina - Charleston, Charleston

32714

RECRUITING

Neurology of Central Florida Research Center, LLC, Altamonte Springs

33487

RECRUITING

SFM Clinical Research, LLC, Boca Raton

41404

RECRUITING

Kyungpook National University Chilgok Hospital, Daegu

83301

RECRUITING

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

156707

RECRUITING

Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul

392006

RECRUITING

Hakodate Municipal Hospital - Dept of Neurology, Hakodate-shi

404327

RECRUITING

China Medical University Hospital, Taichung

7610793

RECRUITING

Kagawa University Hospital - Dept of Neurology, Kita-gun

27157-1078

RECRUITING

Atrium Health Wake Forest Baptist, Winston-Salem

05401

RECRUITING

The University of Vermont Medical Center, Burlington

C1012AAR

RECRUITING

Instituto de Investigaciones Metabolicas (IDIM), Ciudad Autonoma Buenos Aires

Unknown

RECRUITING

Hospital Cordoba, Córdoba

RECRUITING

Fundacion Rosarina de Neurorehabilitacion, Rosario

RECRUITING

INECO Neurociencias Oroño, Rosario

RECRUITING

Centro de Investigaciones Medicas Tucuman, San Miguel de Tucumán

RECRUITING

Gold Coast University Hospital - PARENT, Southport

RECRUITING

Osaka University Hospital - Dept of Neurology/Stroke Care Unit, Suita-shi

RECRUITING

Wielospecjalistyczne Centrum Medyczne Ibismed - Dept of Neurology, Zabrze

0114

RECRUITING

Ltd. Pineo Medical Ecosystem, Tbilisi

RECRUITING

New Hospitals LLC, Tbilisi

0160

RECRUITING

Aversi Clinic Ltd, Tbilisi

286-8520

RECRUITING

IUHW Narita Hospital - Dept of Neurology, Narita-shi

025-0082

RECRUITING

General Hanamaki Hospital - Dept of Neurology, Hanamaki-shi

160-0023

RECRUITING

Tokyo Medical University Hospital - Dept of Neurology, Shinjuku-ku

02841

RECRUITING

Keimyung University Dongsan Hospital, Seoul

06351

RECRUITING

Samsung Medical Center, Seoul

136-705

RECRUITING

Korea University Anam Hospital, Seoul

138-736

RECRUITING

Asan Medical Center, Seoul

S10 2JF

RECRUITING

Royal Hallamshire Hospital - Dept of Neurology, Sheffield

All Listed Sponsors
collaborator

EMD Serono Research & Development Institute, Inc.

INDUSTRY

lead

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT06463587 - Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad) | Biotech Hunter | Biotech Hunter