Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis

Completed · Phase 2 · Has a placebo group

Conditions studied: Generalized Myasthenia Gravis

In brief

The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with generalized Myasthenia Gravis (gMG). Subjects will be randomized in a 1:1:1 ratio to receive daily SC doses of 0.1 mg/kg RA101495, 0.3 mg/kg RA101495, or matching placebo for 12 weeks.

Key facts

Study ID

NCT03315130

Run by

Ra Pharmaceuticals

People needed

45

Starts

2017-10-11

Expected to finish

2020-11-19

Last updated by the study team

2022-07-27

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of gMG [Myasthenia Gravis Foundation of America (MGFA) Class II-IVa] at Screening
• Positive serology for acetylcholine receptor (AChR) autoantibodies
• QMG score ≥ 12 at Screening and Randomization
• No change in corticosteroid dose for at least 30 days prior to Randomization or anticipated to occur during the 12-week Treatment Period
• No change in immunosuppressive therapy, including dose, for at least 30 days prior to Randomization or anticipated to occur during the 12-week Treatment Period

You may not qualify if…

• Thymectomy within 6 months prior to Randomization or scheduled to occur during the 12 week Treatment Period
• History of meningococcal disease
• Current or recent systemic infection within 2 weeks prior to Randomization or infection requiring intravenous (IV) antibiotics within 4 weeks prior to Randomization

Where it is running

• Diagnostic and Medical Clinic - Mobile — Mobile, Alabama, United States
• The Research Center of Southern California — Carlsbad, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• University of California Irvine Health ALS and Neuromuscular Center — Orange, California, United States
• Yale University — New Haven, Connecticut, United States
• George Washington University — Washington D.C., District of Columbia, United States
• University of Florida — Jacksonville, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Maryland — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Lahey Hospital and Medical Center — Burlington, Massachusetts, United States
• Wayne State University — Detroit, Michigan, United States
• Michigan State University — East Lansing, Michigan, United States
• University of Buffalo — Buffalo, New York, United States
• Hospital for Special Surgery — New York, New York, United States
• Mount Sinai Hospital — New York, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Ohio State University — Columbus, Ohio, United States
• Allegheny Neurological Associates — Pittsburgh, Pennsylvania, United States
• Wesley Neurology Clinic — Cordova, Tennessee, United States
• University of Texas Southwestern — Dallas, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• University of Vermont — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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