Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis (RAISE)
Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis (RAISE)
ClinicalTrials.gov ID: NCT04115293
Sponsor: Ra Pharmaceuticals, Inc.
Information provided by: Ra Pharmaceuticals, Inc. (Responsible Party)
Last Update Posted: 2023-05-03
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. 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.
OFFICIAL TITLE
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
INTERVENTION / TREATMENT
Drug: zilucoplan (RA101495)
Drug: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) | 2019-09-17 |
| Primary Completion (Actual) | 2021-12-30 |
| Study Completion (Actual) | 2021-12-30 |
| Enrollment (Actual) | 174 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers | RA101495-02.301 |