Status:
COMPLETED
Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis
Lead Sponsor:
Ra Pharmaceuticals
Conditions:
Generalized Myasthenia Gravis
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2020
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03315130
Start Date
October 11 2017
End Date
November 19 2020
Last Update
July 27 2022
Active Locations (30)
Enter a location and click search to find clinical trials sorted by distance.
1
Diagnostic and Medical Clinic - Mobile
Mobile, Alabama, United States, 36604
2
The Research Center of Southern California
Carlsbad, California, United States, 92011
3
UCLA Medical Center
Los Angeles, California, United States, 90095
4
University of California Irvine Health ALS and Neuromuscular Center
Orange, California, United States, 92868