Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)
Public ClinicalTrials.gov record NCT06463587. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06463587
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Industry
- Enrollment
- 264 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 24, 2024
- Primary completion
- Aug 22, 2028
- Completion
- Nov 11, 2030
- Last update posted
- Aug 11, 2026
2024 – 2030
United States locations
- U.S. sites
- 21
- U.S. states
- 13
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Neuroscience Research, LLC | Phoenix | Arizona | 85032 | Recruiting |
| Advanced Neurosciences Research LLC | Longmont | Colorado | 80501 | Active, not recruiting |
| University of Connecticut Health Center - Department of Medicine | Farmington | Connecticut | 06030-5550 | Recruiting |
| The George Washington University Medical Faculty Associates Foggy Bottom South Pavilion | Washington D.C. | District of Columbia | 20037 | Recruiting |
| Neurology of Central Florida Research Center, LLC | Altamonte Springs | Florida | 32714 | Recruiting |
| SFM Clinical Research, LLC | Boca Raton | Florida | 33487 | Recruiting |
| University of Florida Health Science Center - 300120311 | Jacksonville | Florida | 32209 | Recruiting |
| Neurology Associates, P. A. | Maitland | Florida | 32751 | Recruiting |
| University of South Florida - PARENT - PARENT | Tampa | Florida | 33612 | Recruiting |
| University of Kansas Medical Center Research Institute, Inc. - 3901 Rainbow (MAIN) | Kansas City | Kansas | 66160 | Recruiting |
| UNC Hospitals - PARENT | Chapel Hill | North Carolina | 27599 | Recruiting |
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27157-1078 | Recruiting |
| Miami Valley Hospital South | Centerville | Ohio | 45459 | Recruiting |
| University of Cincinnati | Cincinnati | Ohio | 45219 | Recruiting |
| Clinical Trials of South Carolina - Charleston | Charleston | South Carolina | 29406 | Recruiting |
| Erlanger Health, Inc. - 1123255 | Chattanooga | Tennessee | 37403 | Recruiting |
| Baylor Scott & White Research Institute - Baylor Scott & White Research Institute | Dallas | Texas | 75246 | Recruiting |
| ANESC Research | El Paso | Texas | 79912 | Recruiting |
| Baylor Scott & White Neurology - McKinney | McKinney | Texas | 75071 | Recruiting |
| The University of Vermont Medical Center | Burlington | Vermont | 05401 | Recruiting |
| Integrated Neurology Services - Dr. Simon Fishman's Office | Falls Church | Virginia | 22043 | Active, not recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 127 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06463587, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 11, 2026 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06463587 live on ClinicalTrials.gov.