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NCT06463587 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)
A Phase 3 study of Generalized Myasthenia Gravis, sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 264
- Enrollment target
- 20
- Study locations
NCT06463587 is a Phase 3 study of Generalized Myasthenia Gravis that is actively recruiting participants, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany. The registered enrollment target is 264 participants, above the 121-participant average among 26 other Generalized Myasthenia Gravis trials with a reported enrollment target (118% higher). The trial reports 20 study locations across 13 states.
The verdict
NCT06463587, a Phase 3 study of Generalized Myasthenia Gravis, is actively recruiting participants, sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 264 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Cladribine Low Dose
- DRUG Cladribine High Dose
Study Locations (20)
Florida
- Neurology of Central Florida Research Center, LLC - Altamonte Springs
- SFM Clinical Research, LLC - Boca Raton
- University of Florida Health Science Center - 300120311 - Jacksonville
- Neurology Associates, P. A. - Maitland
- University of South Florida - PARENT - PARENT - Tampa
Texas
- Baylor Scott & White Research Institute - Baylor Scott & White Research Institute - Dallas
- ANESC Research - El Paso
- Baylor Scott & White Neurology - McKinney - McKinney
North Carolina
- UNC Hospitals - PARENT - Chapel Hill
- Atrium Health Wake Forest Baptist - Winston-Salem
Arizona
- Arizona Neuroscience Research, LLC - Phoenix
Colorado
- Advanced Neurosciences Research LLC - Longmont
District of Columbia
- The George Washington University Medical Faculty Associates Foggy Bottom South Pavilion - Washington D.C.
Kansas
- University of Kansas Medical Center Research Institute, Inc. - 3901 Rainbow (MAIN) - Kansas City
Ohio
- Miami Valley Hospital South - Centerville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 264 participants |
| Start Date | 2024-06-25 |
| Est. Completion | 2030-08-19 |
| Phase | Phase 3 |
Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany4 total trials
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06463587
The ClinicalTrials.gov registry entry for NCT06463587 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 264 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 121-participant average among 26 other Generalized Myasthenia Gravis trials with a reported enrollment target (118% higher). The listed sponsor is Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Generalized Myasthenia Gravis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06463587 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Florida, Texas, North Carolina.
Frequently Asked Questions
What is clinical trial NCT06463587 about?
NCT06463587 is a clinical study titled "Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)". 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 or...
What is the current status of trial NCT06463587?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 264 participants. The study started on 2024-06-25. Estimated completion is 2030-08-19.
What conditions does trial NCT06463587 study?
This clinical trial studies the following conditions: Generalized Myasthenia Gravis.
What interventions are being tested in trial NCT06463587?
The interventions under investigation include: Placebo (OTHER), Cladribine Low Dose (DRUG), Cladribine High Dose (DRUG).
Who is sponsoring clinical trial NCT06463587?
This trial is sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06463587 being conducted?
This trial has 20 study locations across Arizona, Colorado, District of Columbia, Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.