Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

Summary

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

Keywords

Generalized Myasthenia Gravis Muscle Weakness Myasthenia Gravis Ravulizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  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).

You CAN'T join if...

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).

Locations

  • University of California - Irvine accepting new patients
    Orange California 92868 United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alexion Pharmaceuticals
ID
NCT03920293
Phase
Phase 3
Study Type
Interventional
Last Updated