Clinical trialNCT06463587RecruitingPhase 3Interventional

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

SponsorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyEnrollment264Generalized Myasthenia Gravis

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Medical Responsible
EMD Serono Research & Development Institute, Inc.
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

148 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Argentina

Expertia S.A- Mautalen Salud E Investigación
Ciudad Autonoma Buenos Aires, Argentina
Valeria Salutto
Recruiting
Instituto de Investigaciones Metabolicas (idim)
Ciudad Autonoma Buenos Aires, Argentina
Fatima Pagani Cassara
Recruiting
Instituto de Investigaciones Neurologicas Raul Carrea, Fleni - de Investigaciones Clinicas del Área de Cardiología Y Enfermedades Metabólicas Asociadas
Ciudad Autonoma Buenos Aires, Argentina
Alberto Daniel Rivero
Recruiting
Hospital Cordoba
Córdoba, Argentina
Susana del Liwacki
Recruiting
Fundacion Rosarina de Neurorehabilitacion
Rosario, Argentina
Carolina Mainella
Recruiting
Ineco Neurociencias Oroño
Rosario, Argentina
Dario Tavolini
Recruiting
Cer San Juan Centro Polivalente de Asistencia E Inv. Clinica
San Juan, Argentina
Juan Carlos Giugni
Recruiting
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, Argentina
Jorge Jose
Recruiting

Australia

Brain and Mind Research Institute
Camperdown, New South Wales, Australia
Stephen Reddel
Recruiting
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Antony Winkel
Recruiting
Princess Alexandra Hospital - Parent
South Brisbane, Queensland, Australia
Stefan Blum
Recruiting
John Hunter Hospital - Parent
City of Burnside, South Australia, Australia
Myintzu Min
Recruiting
Box Hill Hospital - Parent
Box Hill, Victoria, Australia
Katherine Buzzard
Recruiting
Gold Coast University Hospital - Parent
Southport, Australia
Arman Sabet
Recruiting

Belgium

Uz Leuven
Leuven, Belgium
Kristl Claeys
Recruiting
C. H. R. de la Citadelle - Account 1
Liège, Belgium
Stephanie Delstanche
Recruiting

Bulgaria

Medical Center Hera - Branch Montana
Montana, Bulgaria
Plamen Pelov
Recruiting
Umhat 'Dr. Georgi Stranski', Ead
Pleven, Bulgaria
Maya Danovska-Mladenova
Recruiting
Umhat "sv. Georgi", Ead
Plovdiv, Bulgaria
Georgi Slavov
Recruiting
Mhatnp "sv.Naum", Ead - Third Neurology Clinic
Sofia, Bulgaria
Ivan G Milanov
Recruiting
Umhatem 'N.I. Pirogov', Ead
Sofia, Bulgaria
Mariya Dimitrova
Recruiting

Canada

Burnaby Hospital - Fraser Health Multiple Sclerosis Clinic
Burnaby, British Columbia, Canada
Marketa Van den Elzen
Recruiting

China

the First Affiliated Hospital of Bengbu Medical College
Anhui Sheng, Anhui, China
Weidong Qian
Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Yuzhou Guan
Recruiting
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
Yuwei Da
Recruiting
the First Affiliated Hospital of Guangzhou University of Chinese Medicine - 300164595
Guangzhou, Guangdong, China
Qilong Jiang
Recruiting
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
Zucai Xu
Recruiting
Shijiazhuang People'S Hospital
Shijiazhuang, Hebei, China
Guoyan Qi
Recruiting
Henan Provincial People'S Hospital
Zhengzhou, Henan, China
Mingming Ma
Recruiting
Xiangya Hospital, Central South University
Changsha, Hu'nan, China
Huan Yang
Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China
Zhijun Li
Recruiting
China-Japan Union Hospital of Jilin University - 300173736
Changchun, Jilin, China
Songyan Liu
Recruiting
the First Hospital of Jilin University - the First Hospital of Jilin University
Changchun, Jilin, China
Hui Deng
Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Juan Feng
Recruiting
Huashan Hospital, Fudan University - Neurology
Shanghai, Shanghai Municipality, China
Sushan Luo
Recruiting
Xi 'An International Medical Center
Xi’an, Shanxi, China
Hong Lin
Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Hongyu Zhou
Recruiting

France

Chu Nice - Hôpital Pasteur - Cardiology
Nice, Alpes Maritimes, France
Saskia Bresch
Recruiting
Chu Strasbourg - Hopital Hautepierre - Service Anesthesie-Reanimation&medecine Peri-Opera
Strasbourg, Bas Rhin, France
Aleksandra Nadaj Pakleza
Recruiting
Chu de Grenoble - Hôpital Albert Michallon - Centre de Références Des Maladies Neuromusculaires
La Tronche, Isere, France
Emmeline Lagrange
Recruiting

108 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Cladribine High DoseCladribine Low Dose

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 25 Jun 2024
Primary completion: 23 Aug 2028
Completion: 12 Nov 2030
Last update posted: 12 Aug 2026
Registered enrollment: 264
Registry id: NCT06463587

Cross-registrations

EU-CTR / CTIS (EudraCT)2023-507746-83-00jRCT/UMIN (Japan)jRCT2031240175

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.