Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis
The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab for the treatment of participants with generalized myasthenia gravis (gMG).
- Generalized Myasthenia Gravis
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Diagnosed with Myasthenia Gravis at least 6 months (180 days) prior to the date of the Screening Visit as confirmed by specific criteria.
- Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at screening.
- MG-ADL profile must be ≥ 6 at screening and randomization (Day 1).
- Vaccinated against meningococcal infections within 3 years prior to, or at the time of, initiating study drug to reduce the risk of meningococcal infection (N meningitidis).
1. Any active or untreated thymoma. History of thymic carcinoma or thymic malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥ 5 years before screening.
2. History of thymectomy within the 12 months prior to screening.
3. History of N meningitidis infection.
4. Use of the following within the time period specified below:
- IV immunoglobulin within 4 weeks of randomization
- Use of plasma exchange within 4 weeks of randomization
- Use of rituximab within 6 months of screening
5. Participants who have received previous treatment with complement inhibitors (for example, eculizumab).
- Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Triple (Participant, Care Provider, Investigator)
- Masking Description
- All investigative site personnel, sponsor staff, sponsor designees, staff directly associated with the conduct of the study, and all participants will be blinded to treatment assignments.
|Participants will receive ravulizumab for the duration of the study.||
|Participants will receive placebo during the 26-week randomized-controlled period of the study, after which they will enter the open-label extension period of the study and receive ravulizumab.||
- Alexion Pharmaceuticals
Study ContactAlexion Pharmaceuticals Inc.