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
200 South Manchester Avenue
Orange, California 92868
Orange, California 92868
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