Generalized Myasthenia Gravis
Conditions
Interventions
Drug: rozanolixizumab
rozanolixizumab solution for injection
Sponsors
Ikeda kaori
Eligibility
Sex/Gender
All
Inclusion criteria
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 (TP) and has a worsening of gMG symptoms in the Observation Period (OP) of MG0006
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Occurrence of serious Treatment-Emergent Adverse Events (TEAEs) up to the End of Study (EOS) Visit - Occurrence of TEAEs leading to permanent withdrawal of IMP up to the EOS Visit - Occurrence of Adverse Event(s) of Special Monitoring (AESM) up to the EOS Visit | — |
Secondary
| Measure | Time frame |
|---|---|
| - Percent change in total Immunoglobulin G (IgG) from Baseline to the end of Week 6 of each TP - Absolute change in total IgG from Baseline to the end of Week 6 of each TP - Change from Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score at the end of Week 6 of each TP - Change from Baseline in Quantitative Myasthenia Gravis (QMG) total score at the end of Week 6 of each TP | — |
Countries
Italy, Japan, Poland, Taiwan
Contacts
Public ContactGlobal Clinical Science & Operation
UCB Japan Co., Ltd.
Outcome results
None listed