Trials / Completed
CompletedNCT04115293
Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis
A Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 174 (actual)
- Sponsor
- Ra Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 74 Years
- Healthy volunteers
- Not accepted
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. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | zilucoplan (RA101495) | Daily subcutaneous (SC) injection |
| DRUG | Placebo | Daily subcutaneous (SC) injection |
Timeline
- Start date
- 2019-09-17
- Primary completion
- 2021-12-30
- Completion
- 2021-12-30
- First posted
- 2019-10-04
- Last updated
- 2025-07-16
- Results posted
- 2023-01-17
Locations
77 sites across 10 countries: United States, Canada, France, Germany, Italy, Japan, Norway, Poland, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04115293. Inclusion in this directory is not an endorsement.