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



Status:Active, not recruiting
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 85
Updated:3/28/2019
Start Date:October 11, 2017
End Date:April 2019

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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

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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
27
sites
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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85 S Prospect St
Burlington, Vermont 5405
(802) 656-3131
University of Vermont The University of Vermont combines faculty-student relationships most commonly found in a...
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Burlington, VT
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Chapel Hill, NC
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Detroit, MI
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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Tampa, FL
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Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Baltimore, MD
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Buffalo, New York 14215
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Burlington, Massachusetts 01805
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Carlsbad, California 92011
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Cordova, Tennessee 38018
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Dallas, Texas 75390
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East Lansing, Michigan 48824
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Edmonton, Alberta
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Jacksonville, Florida 32209
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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3237 South 16th Street
Milwaukee, Wisconsin 53215
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1700 SpringHill Avenue
Mobile, Alabama 36604
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Mobile, AL
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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535 E 70th St
New York, New York 10021
(212) 606-1000
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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New York, New York 10029
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200 South Manchester Avenue
Orange, California 92868
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Orange, CA
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Pittsburgh, Pennsylvania 15212
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Washington, District of Columbia 20052
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