Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis
Study Identifier:
ALXN1210-MG-306
ClinicalTrials.gov Identifier:
EudraCT Identifier:
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete
Available Documents
Study Details
Medical Condition
- Generalized Myasthenia Gravis
Study Drug
- Biological: Ravulizumab
- Drug: Placebo
Date
Mar 2019 - May 2021
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- Diagnosed with Myasthenia Gravis at least 6 months (180 days) prior to the date of the Screening Visit as confirmed by specific criteria.
- Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at screening.
- MG-ADL profile must be ≥ 6 at screening and randomization (Day 1).
- 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
- 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.
- History of thymectomy within the 12 months prior to screening.
- History of N meningitidis infection.
- 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
- Participants who have received previous treatment with complement inhibitors (for example, eculizumab).
Sex
Female & Male
Age
N/A
Study Details
Medical Condition
- Generalized Myasthenia Gravis
Study Drug
- Biological: Ravulizumab
- Drug: Placebo
Date
Mar 2019 - May 2021
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- Diagnosed with Myasthenia Gravis at least 6 months (180 days) prior to the date of the Screening Visit as confirmed by specific criteria.
- Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at screening.
- MG-ADL profile must be ≥ 6 at screening and randomization (Day 1).
- 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
- 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.
- History of thymectomy within the 12 months prior to screening.
- History of N meningitidis infection.
- 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
- Participants who have received previous treatment with complement inhibitors (for example, eculizumab).
Protocol 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).
Trial Locations
Location
Status
Location
Research Site
Phoenix, Arizona, United States, 85013
Status
N/A
Location
Research Site
Phoenix, Arizona, United States, 85018
Status
N/A
Location
Research Site
Phoenix, Arizona, United States, 85028
Status
N/A
Location
Research Site
Irvine, California, United States, 92617
Status
N/A
Location
Research Site
Loma Linda, California, United States, 92354
Status
N/A
Location
Research Site
Palo Alto, California, United States, 94304
Status
N/A
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