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 |
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.
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
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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University of Vermont The University of Vermont combines faculty-student relationships most commonly found in a...
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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University of Utah Research is a major component in the life of the U benefiting...
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University of South Florida The University of South Florida is a high-impact, global research university...
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University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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200 South Manchester Avenue
Orange, California 92868
Orange, California 92868
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