Generalized Myasthenia Gravis
Conditions
Interventions
Rozanolixizumab self-administration via Syringe Driver or Manual Push.
Sponsors
Kaori Ikeda
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Study participant must have a documented diagnosis of generalized Myasthenia Gravis (gMG) - Study participant is willing to perform and capable of performing home self-administration - Study participant is considered for additional rozanolixizumab treatment with the posology proposed in this study - Body weight >=35 kg - Study participants may be male or female
Exclusion criteria
Exclusion criteria: - Study participant has a known hypersensitivity to any components of the study medication or other anti-neonatal Fc receptor (FcRn) medications - Study participant with a known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent tuberculosis infection (LTBI), or current or history of nontuberculous mycobacterial infection (NTMBI) - Study participant has a clinically relevant active infection or a history of serious infection (resulting in hospitalization or requiring IV antibiotic treatment) within 6 weeks before the Baseline Visit - The study participant previously participated in any rozanolixizumab MG study and met any mandatory withdrawal or mandatory study drug discontinuation criteria - Study participant has received a live vaccination within 4 weeks before starting treatment, or a Bacillus Calmette Guerin (BCG) vaccine within 1 year before starting treatment; or intends to have a live vaccination during the course of the study or within 8 weeks following the last dose of rozanolixizumab - Study participant with severe (defined as Grade 3 on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale) weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Successful self-administration of rozanolixizumab (with correct use of syringe driver and manual push, respectively) during the Selfadministration Period at Visit 13 - Successful self-administration of rozanolixizumab (with correct use of syringe driver and manual push, respecively) during the Selfadministration Period at Visit 19 | — |
Secondary
| Measure | Time frame |
|---|---|
| - Occurrence of Treatment-Emergent Adverse Events (TEAEs) after syringe driver or manual push self-administration from Visit 2 up to the End of Study Visit - Occurrence of local site reactions up to 24 hours after each administration during the Training Period and Self-administration Periods - Occurrence of medication errors associated with adverse reactions during the 2 Self-administration Periods of the study | — |
Countries
Canada, Georgia, Germany, Italy, Japan, Poland, Serbia, Spain, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Science & Operation
UCB Japan Co., Ltd.
Outcome results
None listed