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Brief Title: Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis
Official Title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of RA101495 in Subjects With Generalized Myasthenia Gravis
Study ID: NCT03315130
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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, 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
Center for Neurological Disorders, Milwaukee, Wisconsin, United States
University of Alberta Hospital, Edmonton, Alberta, Canada
London Health Sciences Centre University Hospital, London, Ontario, Canada
Toronto General Hospital, Toronto, Ontario, Canada
Montreal Neurological Institute and Hospital, Montreal, Quebec, Canada
Name: UCB Cares
Affiliation: 001 844 599 2273 (UCB)
Role: STUDY_DIRECTOR