Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis
Trial ID or NCT#
NCT03920293
Status
NOT RECRUITING
Purpose
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).
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- 1. Diagnosed with Myasthenia Gravis at least 6 months (180 days) prior to the date of the Screening Visit as confirmed by specific criteria. 2. Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at screening. 3. MG-ADL profile must be ≥ 6 at screening and randomization (Day 1). 4. 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).
Exclusion Criteria:
- Medical Conditions 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).
Investigator(s)
Neelam Goyal, MD
Neuromuscular neurologist,
Neurophysiologist
Clinical Associate Professor, Neurology & Neurological Sciences
View on ClinicalTrials.gov
