Status:
COMPLETED
Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis
Lead Sponsor:
Ra Pharmaceuticals, Inc.
Conditions:
Myasthenia Gravis, Generalized
Eligibility:
All Genders
18-74 years
Phase:
PHASE3
Brief Summary
The RAISE study is a multicenter, randomized, double-blind, placebo controlled study to confirm the efficacy, safety, and tolerability of zilucoplan in subjects with generalized Myasthenia Gravis. Sub...
Eligibility Criteria
Inclusion
- Diagnosis of gMG \[Myasthenia Gravis Foundation of America (MGFA) Class II-IV\] at Screening
- Positive serology for acetylcholine receptor (AChR) autoantibodies
- MG-ADL Score of ≥ 6 at Screening and Baseline
- QMG score ≥ 12 at Screening and Baseline
- No change in corticosteroid dose for at least 30 days prior to Baseline or anticipated to occur during the 12-week Treatment Period
- No change in immunosuppressive therapy, including dose, for at least 30 days prior to Baseline or anticipated to occur during the 12-week Treatment Period
Exclusion
- Thymectomy within 12 months prior to Baseline or scheduled to occur during the 12 week Treatment Period
- History of meningococcal disease
- Current or recent systemic infection within 2 weeks prior to Baseline or injection requiring intravenous (IV) antibiotics within 4 weeks prior to Baseline
Key Trial Info
Start Date :
September 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2021
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT04115293
Start Date
September 17 2019
End Date
December 30 2021
Last Update
July 16 2025
Active Locations (77)
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1
Site 41: Diagnostic and Medical Clinic
Mobile, Alabama, United States, 36604
2
Site 116: Neuromuscular Clinic and Research Center
Phoenix, Arizona, United States, 85028
3
Site 4: University of Southern California
Los Angeles, California, United States, 90033
4
Site 31: University of California Irvine
Orange, California, United States, 92868