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Spots Global Cancer Trial Database for Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis

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Trial Identification

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

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: UCB Cares

Affiliation: 001 844 599 2273 (UCB)

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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