Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis
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ClinicalTrials.gov Identifier: NCT03920293 |
Recruitment Status :
Completed
First Posted : April 18, 2019
Results First Posted : May 26, 2022
Last Update Posted : August 29, 2023
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Sponsor:
Alexion Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Alexion Pharmaceuticals, Inc.
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Tracking Information | |||||
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First Submitted Date ICMJE | April 16, 2019 | ||||
First Posted Date ICMJE | April 18, 2019 | ||||
Results First Submitted Date ICMJE | May 3, 2022 | ||||
Results First Posted Date ICMJE | May 26, 2022 | ||||
Last Update Posted Date | August 29, 2023 | ||||
Actual Study Start Date ICMJE | March 26, 2019 | ||||
Actual Primary Completion Date | May 11, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Change From Baseline In Myasthenia Gravis-Activities Of Daily Living (MG-ADL) Total Score At Week 26 [ Time Frame: Baseline, Week 26 ] The MG-ADL is an 8-point questionnaire that focused on relevant symptoms and functional performance of activities of daily living in participants with MG. The 8 items of the MGADL questionnaire were derived from symptom-based components of the original 13-item QMG scale to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. In this functional status instrument, each response was graded 0 (normal) to 3 (most severe). The range of total MG-ADL score was 0 to 24. A decrease in score indicated improvement. Estimates were based on Mixed Effect Repeated Measures (MMRM) that included treatment group, stratification factor region, and MG-ADL total score at baseline, study visit, and study visit by treatment group interaction.
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Original Primary Outcome Measures ICMJE |
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.
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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.
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis | ||||
Official Title ICMJE | 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 | ||||
Brief 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). | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | 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
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Condition ICMJE | Generalized Myasthenia Gravis | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
175 | ||||
Original Estimated Enrollment ICMJE |
160 | ||||
Actual Study Completion Date ICMJE | May 25, 2023 | ||||
Actual Primary Completion Date | May 11, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Medical Conditions
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Austria, Canada, Czechia, Denmark, France, Germany, Israel, Italy, Japan, Korea, Republic of, Netherlands, Portugal, Spain, Switzerland, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03920293 | ||||
Other Study ID Numbers ICMJE | ALXN1210-MG-306 2018-003243-39 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Alexion Pharmaceuticals, Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Alexion Pharmaceuticals, Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Alexion Pharmaceuticals, Inc. | ||||
Verification Date | August 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |