The purpose of the study is to evaluate the safety and tolerability of switching from intravenous (IV) complement component 5 (C5) inhibitors to subcutaneous (SC) Zilucoplan in study participants with generalized myasthenia gravis (gMG)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Subcutaneous injection
Mg0017 50564
Scottsdale, Arizona, United States
Mg0017 50559
Los Angeles, California, United States
Mg0017 50593
Rancho Mirage, California, United States
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Over the Main Treatment Period
An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. A TEAE was defined as an AE starting on or after the time of first administration of investigational medicinal product (IMP) and up to and including 40 days after the final dose (or last contact depending on which occurs first).
Time frame: From Baseline (Day 1) to Safety Follow-Up Visit (40 days post last dose) of Main Treatment Period (up to approximately 19 weeks)
Percentage of Participants With TEAEs Leading to Withdrawal of Study Medication Over the Main Treatment Period
An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. A TEAE was defined as an AE starting on or after the time of first administration of IMP and up to and including 40 days after the final dose (or last contact depending on which occurs first).
Time frame: From Baseline (Day 1) to Safety Follow-Up Visit (40 days post last dose) of Main Treatment Period (up to approximately 19 weeks)
Change From Baseline to Week 12 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score
The MG-ADL is a brief 8-item interviewer-administered patient-reported outcome (PRO) designed to evaluate MG symptom severity. The MG-ADL targets symptoms and disability across ocular, bulbar, respiratory, and axial symptoms. Each item is assessed on a 4-point scale, where a score of 0 represents normal function and a score of 3 represents severely decreased ability to perform that function. The total MG-ADL score ranges from 0 to 24, with a higher score indicating more severe impairment. A positive change in score indicates worsening and negative change indicates improvement.
Time frame: From Baseline to Week 12
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Mg0017 50099
San Francisco, California, United States
Mg0017 50557
O'Fallon, Illinois, United States
Mg0017 50556
Chapel Hill, North Carolina, United States
Mg0017 50086
Charlotte, North Carolina, United States
Mg0017 50076
Columbus, Ohio, United States
Mg0017 50555
Austin, Texas, United States
Mg0017 50304
Dallas, Texas, United States
...and 2 more locations
Change From Baseline to Week 12 in the Quantitative Myasthenia Gravis (QMG) Score
The QMG is a standardized and validated quantitative strength scoring system that included 13 items in the following categories: ocular and facial involvement, swallowing, speech, limb strength, and forced vital capacity. Scoring for each item ranges from no weakness (0) to severe weakness (3), with an overall score range from 0 to 39. Higher scores represent more severe impairment. A positive change in score indicates worsening and negative change indicates improvement.
Time frame: From Baseline to Week 12
Percentage of Participants With Serious TEAEs Over the Main Treatment Period
Treatment-emergent serious adverse events (serious TEAEs) were any untoward medical incidence in a participant during administered study treatment, whether or not these events were related to study treatment and additionally were emergent untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Required in patient hospitalisation or prolongation of existing hospitalisation * Results in persistent disability/incapacity * Was a congenital anomaly or birth defect * Important medical events
Time frame: From Baseline (Day 1) to Safety Follow-Up Visit (40 days post last dose) of Main Treatment Period (up to approximately 19 weeks)
Percentage of Participants With Study Withdrawal Over the Main Treatment Period
Percentage of participants with study withdrawal based to pre-defined reasons in the protocol were reported.
Time frame: From Baseline (Day 1) to Safety Follow-Up Visit (40 days post last dose) of Main Treatment Period (up to approximately 19 weeks)