The purpose of the study is to evaluate the clinical efficacy of UCB7665 as a chronic-intermittent treatment in subjects with generalized myasthenia gravis (MG) who are classified as moderate to severe.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
43
UCB7665 will be administered in 2 different dosages (dose 1 and dose 2). UCB7665 (INN: Rozanolixizumab) is a humanized monoclonal antibody that is being developed for treatment of IgG autoantibody-mediated conditions such as myasthenia gravis (MG)
Placebo will be administered in period 1 of dosage regimen 2.
Mg0002 712
Los Angeles, California, United States
Mg0002 701
Orange, California, United States
Mg0002 713
Miami, Florida, United States
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score to Visit 9
The total QMG score was obtained by summing the responses to each individual item (13 items; Responses: None=0, Mild=1, Moderate=2, Severe=3). The score ranges from 0 to 39, with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Time frame: From Baseline to Visit 9 (up to Day 29)
Change From Baseline in Myasthenia Gravis-Composite Score to Visit 9
The total Myasthenia Gravis (MG)-composite score was obtained by summing the responses to each individual item (10 items; Grade: 0-9 depending on item). The score ranges from 0 to 50, with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Time frame: From Baseline to Visit 9 (up to Day 29)
Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MGADL) Score to Visit 9
The total MGDAL score was obtained by summing the responses to each individual item (8 items; Grades: 0, 1, 2, 3). The score ranges from 0 to 24, with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Time frame: From Baseline to Visit 9 (up to Day 29)
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Mg0002 708
Tampa, Florida, United States
Mg0002 707
Augusta, Georgia, United States
Mg0002 704
Columbus, Ohio, United States
Mg0002 102
Brussels, Belgium
Mg0002 103
Ghent, Belgium
Mg0002 101
Leuven, Belgium
Mg0002 203
London, Canada
...and 10 more locations