Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis

Completed · Phase 3 · Has a placebo group

Conditions studied: Generalized Myasthenia Gravis

In brief

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).

Key facts

Study ID

NCT03920293

Run by

Alexion Pharmaceuticals, Inc.

People needed

175

Starts

2019-03-12

Expected to finish

2023-05-25

Last updated by the study team

2024-05-28

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• Medical Conditions
• 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.
• History of thymectomy within the 12 months prior to screening.
• History of N meningitidis infection.
• 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
• Participants who have received previous treatment with complement inhibitors (for example, eculizumab).

Where it is running

• Research Site — Phoenix, Arizona, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Irvine, California, United States
• Research Site — Loma Linda, California, United States
• Research Site — Palo Alto, California, United States
• Research Site — San Francisco, California, United States
• Research Site — Sylmar, California, United States
• Research Site — Aurora, Colorado, United States
• Research Site — Colorado Springs, Colorado, United States
• Research Site — Fort Collins, Colorado, United States
• Research Site — Fairfield, Connecticut, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Rolling Meadows, Illinois, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Kansas City, Kansas, United States
• Research Site — Lexington, Kentucky, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Burlington, Massachusetts, United States
• Research Site — Ann Arbor, Michigan, United States
• Research Site — East Lansing, Michigan, United States
• Research Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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