Phase 3
Completed N=175
Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis
Source: ClinicalTrials.gov NCT03920293 ↗Enrolled (actual)
175
Serious AEs
26.8%
Results posted
May 2022
Primary outcomePrimary: Change From Baseline In Myasthenia Gravis-Activities Of Daily Living (MG-ADL) Total Score At Week 26 — -3.1; -1.4 units on a scale — p==0.0009
◆ Published Evidence
Highly cited
218citations · ~55 / year
Terminal Complement Inhibitor Ravulizumab in Generalized Myasthenia Gravis.
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).
Linked Publications (4)
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Terminal Complement Inhibitor Ravulizumab in Generalized Myasthenia Gravis.
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Long-term efficacy and safety of ravulizumab in adults with anti-acetylcholine receptor antibody-positive generalized myasthenia gravis: results from the phase 3 CHAMPION MG open-label extension.
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Ravulizumab pharmacokinetics and pharmacodynamics in patients with generalized myasthenia gravis.
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Ravulizumab for the treatment of myasthenia gravis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline In Myasthenia Gravis-Activities Of Daily Living (MG-ADL) Total Score At Week 26 |
-3.1; -1.4 | =0.0009 sig |
| SECONDARY Change From Baseline In The Quantitative Myasthenia Gravis (QMG) Total Score At Week 26 |
-2.8; -0.8 | — |
| SECONDARY Percentage of Participants With a Quantitative Myasthenia Gravis (QMG) Total Score Reduction of at Least 5 Points At Week 26 |
30.0; 11.3 | — |
| SECONDARY Change From Baseline In the Revised 15 Component Myasthenia Gravis Quality of Life (MG-QOL15r) At Week 26 |
-3.3; -1.6 | — |
| SECONDARY Change From Baseline in Neurological Quality of Life (Neuro-QoL) Fatigue Score at Week 26 |
-7.0; -4.8 | — |
| SECONDARY Percentage of Participants With a Myasthenia Gravis Activities of Daily Living (MG-ADL) Total Score Reduction of at Least 3 Points At Week 26 |
56.7; 34.1 | — |
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT03920293) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.