Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad) (NCT06463587)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Arizona Neuroscience Research, LLC — Phoenix, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (148 Sites)
Showing the first 25 of 148 sites.
- Arizona Neuroscience Research, LLC — Phoenix, Arizona
- Advanced Neurosciences Research LLC — Longmont, Colorado
- University of Connecticut Health Center - Department of Medicine — Farmington, Connecticut
- The George Washington University Medical Faculty Associates Foggy Bottom South Pavilion — Washington D.C., District of Columbia
- Neurology of Central Florida Research Center, LLC — Altamonte Springs, Florida
- SFM Clinical Research, LLC — Boca Raton, Florida
- University of Florida Health Science Center - 300120311 — Jacksonville, Florida
- Neurology Associates, P. A. — Maitland, Florida
- University of South Florida - PARENT - PARENT — Tampa, Florida
- University of Kansas Medical Center Research Institute, Inc. - 3901 Rainbow (MAIN) — Kansas City, Kansas
- UNC Hospitals - PARENT — Chapel Hill, North Carolina
- Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina
- Miami Valley Hospital South — Centerville, Ohio
- University of Cincinnati — Cincinnati, Ohio
- Clinical Trials of South Carolina - Charleston — Charleston, South Carolina
- Erlanger Health, Inc. - 1123255 — Chattanooga, Tennessee
- Baylor Scott & White Research Institute - Baylor Scott & White Research Institute — Dallas, Texas
- ANESC Research — El Paso, Texas
- Baylor Scott & White Neurology - McKinney — McKinney, Texas
- The University of Vermont Medical Center — Burlington, Vermont
- Integrated Neurology Services - Dr. Simon Fishman's Office — Falls Church, Virginia
- Expertia S.A- Mautalen Salud e Investigación — Ciudad Autonoma Buenos Aires,
- Instituto de Investigaciones Neurologicas Raul Carrea, FLENI - de Investigaciones Clinicas del área de Cardiología y enfermedades metabólicas asociadas — Ciudad Autonoma Buenos Aires,
- Instituto de Investigaciones Metabolicas (IDIM) — Ciudad Autonoma Buenos Aires,
- Hospital Cordoba — Córdoba,
📞 Contact the Study Coordinator
Phone: (888) 275-7376
Email: eMediUSA@emdserono.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis — Scottsdale, Arizona
- Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis — Orange, California
- Evaluation of PK, PD, Efficacy, Safety, and Immunogenicity of IV Ravulizumab in Pediatric Participants With Generalized Myasthenia Gravis — Los Angeles, California
- Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis — Phoenix, Arizona
- A Phase III Study to Investigate Efficacy, Safety and Tolerability of Iptacopan Compared With Placebo in Participants Aged 18 to 85 Years With gMG. — Scottsdale, Arizona
Explore by condition: All Generalized Myasthenia Gravis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.