OncoMatch/Clinical Trials/NCT06463587
Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)
Is NCT06463587 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Cladribine Low Dose and Cladribine High Dose for generalized myasthenia gravis.
Treatment: Cladribine Low Dose · Cladribine High Dose — 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.
Check if I qualifyExtracted eligibility criteria
Disease stage
Required: Stage MYASTHENIA GRAVIS FOUNDATION OF AMERICA CLASS II, III, IVA (Myasthenia Gravis Foundation of America)
meeting clinical criteria for Myasthenia Gravis Foundation of America Class II to IVa classification
Prior therapy
Cannot have received: nonsteroidal immunosuppressant (azathioprine, mycophenolate mofetil, methotrexate, cyclosporine, tacrolimus)
Exception: if discontinued within 4 weeks prior to randomization
Treatment with nonsteroidal immunosuppressants, used in gMG, such as azathioprine, mycophenolate mofetil, methotrexate, cyclosporine, tacrolimus within 4 weeks prior to randomization
Cannot have received: complement inhibitor (eculizumab, rozanolixizumab, efgartigimod, ravulizumab, zilucoplan)
Treatment with eculizumab, rozanolixizumab efgartigimod, ravulizumab, or zilucoplan within 8 weeks prior to randomization
Cannot have received: cladribine (cladribine)
participants with any prior exposure to cladribine may not enter the study regardless of timing of exposure
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Arizona Neuroscience Research, LLC · Phoenix, Arizona
- Advanced Neurosciences Research LLC · Longmont, Colorado
- 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
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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