Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03920293 |
Recruitment Status :
Active, not recruiting
First Posted : April 18, 2019
Last Update Posted : March 15, 2022
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Condition or disease | Intervention/treatment | Phase |
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Generalized Myasthenia Gravis | Biological: Ravulizumab Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 175 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Masking Description: | All investigative site personnel, sponsor staff, sponsor designees, staff directly associated with the conduct of the study, and all participants will be blinded to treatment assignments. |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | March 26, 2019 |
Actual Primary Completion Date : | May 11, 2021 |
Estimated Study Completion Date : | December 31, 2023 |

Arm | Intervention/treatment |
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Experimental: Ravulizumab
Participants will receive ravulizumab for the duration of the study.
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Biological: Ravulizumab
Concentrated sterile, preservative-free aqueous solution (10 milligrams [mg]/milliliter [mL]) in single-use, 30-mL vial for intravenous (IV) infusion. Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight.
Other Names:
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Placebo Comparator: Placebo
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.
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Drug: Placebo
Matching, sterile, preservative-free aqueous solution in single-use, 30-mL vial for IV infusion. Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight. |
- Change From Baseline In Myasthenia Gravis-Activities Of Daily Living (MG-ADL) Total Score At Week 26 [ Time Frame: Baseline, Week 26 ]To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the MG-ADL profile.
- Change From Baseline In The Quantitative Myasthenia Gravis (QMG) Total Score At Week 26 [ Time Frame: Baseline, Week 26 ]To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the QMG total score.
- Change From Baseline In the Revised 15 Component Myasthenia Gravis Quality of Life (MG-QOL15r) At Week 26 [ Time Frame: Baseline, Week 26 ]To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the MG-QOL15r score
- 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 ]To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the MG-ADL total score
- 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 ]To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the QMG total score

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920293

Responsible Party: | Alexion Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT03920293 |
Other Study ID Numbers: |
ALXN1210-MG-306 2018-003243-39 ( EudraCT Number ) |
First Posted: | April 18, 2019 Key Record Dates |
Last Update Posted: | March 15, 2022 |
Last Verified: | March 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Myasthenia Gravis Muscle Weakness Muscular Diseases Musculoskeletal Diseases Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Pathologic Processes Paraneoplastic Syndromes, Nervous System Nervous System Neoplasms Neoplasms by Site Neoplasms |
Paraneoplastic Syndromes Autoimmune Diseases of the Nervous System Neurodegenerative Diseases Neuromuscular Junction Diseases Neuromuscular Diseases Autoimmune Diseases Immune System Diseases Ravulizumab Complement Inactivating Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |