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

Alexion Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Generalized Myasthenia Gravis

Treatments: Drug: Placebo; Biological: Ravulizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03920293

ALXN1210-MG-306

2018-003243-39 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 175 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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175 participants in 2 patient groups, including a placebo group

Ravulizumab

Experimental group

Description:

Participants will receive ravulizumab for the duration of the study.

Treatment:

Biological: Ravulizumab

Placebo

Placebo Comparator group

Description:

Participants will receive placebo during the 26-week randomized-controlled period of the study, after which they will enter the open-label extension period of the study and receive ravulizumab.

Treatment:

Drug: Placebo