MG0008
MG0008
An open-label Extension study to evaluate rozanolixizumab in pediatric study participants with generalized myasthenia gravis
Brief summary
The purpose of the study is to assess the long term safety and tolerability of additional 6-week treatment cycles with rozanolixizumab in pediatric participants with generalized Myasthenia Gravis (gMG) aged ≥2 at the time of the Screening Visit of MG0006.
Medical Condition
Generalized Myasthenia Gravis
Min. Age
2
Years
Max. Age
-
Who Can Join?
All
Status
Enrolling by invitation
Inclusion criteria
Study participant must meet one of the following: - Study participant completed MG0006 according to the protocol - Study participant completed the MG0006 Treatment Period and has a worsening of generalized myasthenia gravis (gMG) symptoms in the Observation Period of MG0006
Exclusion criteria
- Study participant met any mandatory withdrawal or mandatory permanent investigational medicinal product (IMP) discontinuation criteria in MG0006 or permanently discontinued IMP - Study participant has a known hypersensitivity to any components of the IMP or other neonatal Fc receptor (FcRn) drugs - Study participant has any laboratory abnormality that, in the opinion of the Investigator, is clinically significant, has not resolved at Baseline, and could jeopardize or compromise the study participant’s ability to participate in this study
Study Medication Description
Study Medication:
RYSTIGGO
Other Descriptive Name:
rozanolixizumab
Placebo
No
Comparator:
No
Refer to a friend
Study Dates
October 2024
Actual Start Date of Enrollment
December 2027
Planned Study Completion Date