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Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis
Not Recruiting
Trial ID: NCT03920293
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
Stanford Investigator(s)
Neelam Goyal, MD
Clinical Associate Professor, Neurology & Neurological Sciences
Eligibility
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).
Intervention(s):
biological: Ravulizumab
drug: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305