Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis
Purpose
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. Subjects will be randomized in a 1:1 ratio to receive daily SC doses of 0.3 mg/kg zilucoplan or placebo for 12 weeks.
Condition
- Myasthenia Gravis, Generalized
Eligibility
- Eligible Ages
- Between 18 Years and 74 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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 Criteria
- 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 0.3 mg/kg zilucoplan (RA101495) |
|
|
|
Placebo Comparator Placebo |
|
More Details
- Status
- Completed
- Sponsor
- Ra Pharmaceuticals, Inc.