Trial Search Results

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

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).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Alexion Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Biological: Ravulizumab
  • Drug: Placebo

Phase:

Phase 3

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).

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting