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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 March 2022
• Main ID: NCT03920293
• Date of registration: 16/04/2019
• Prospective Registration: No
• Primary sponsor: Alexion Pharmaceuticals
• Public title: Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis
• Scientific 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
• Date of first enrolment: March 26, 2019
• Target sample size: 175
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03920293
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

Austria, Canada, Czechia, Denmark, France, Germany, Israel, Italy, Japan, Korea, Republic of, Netherlands, Portugal, Spain, Switzerland, United States

Key inclusion & exclusion 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:

- 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).



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Generalized Myasthenia Gravis

Intervention(s)

Drug: Placebo

Biological: Ravulizumab

Primary Outcome(s)

Change From Baseline In Myasthenia Gravis-Activities Of Daily Living (MG-ADL) Total Score At Week 26 [Time Frame: Baseline, Week 26]

Secondary Outcome(s)

Change From Baseline In The Quantitative Myasthenia Gravis (QMG) Total Score At Week 26 [Time Frame: Baseline, Week 26]

Change From Baseline In The Myasthenia Gravis Activities of Daily Living (MG-ADL) Total Score of at least 3 points At Week 26 [Time Frame: Baseline, Week 26]

Change From Baseline In the Revised 15 Component Myasthenia Gravis Quality of Life (MG-QOL15r) At Week 26 [Time Frame: Baseline, Week 26]

Change From Baseline In the The Quantitative Myasthenia Gravis (QMG) total score by at least 5 points At Week 26 [Time Frame: Baseline, Week 26]

Secondary ID(s)

2018-003243-39

ALXN1210-MG-306

Source(s) of Monetary Support

Please refer to primary and secondary sponsors