For Healthcare Professionals

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

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About the study

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).
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

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:
  5. IV immunoglobulin within 4 weeks of randomization
  6. Use of plasma exchange within 4 weeks of randomization
  7. Use of rituximab within 6 months of screening
  8. Participants who have received previous treatment with complement inhibitors (for example, eculizumab).
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 855-752-2356Email iconEmail Study Center

Study’s details


Contition

Generalized Myasthenia Gravis

Age

18+

Phase

Phase 3

Participants needed

175

Est. Completion Date

Dec 2023

Treatment type

Interventional


Sponsor

Alexion Pharmaceuticals

ClinicalTrials.gov identifier

NCT03920293

Study number

ALXN1210-MG-306

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