MG0007
MG0007
An Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis
Brief summary
The purpose of this study is to assess the safety, tolerability and efficacy of additional 6-week treatment cycles with rozanolixizumab in study participants with generalized myasthenia gravis (gMG).Medical Condition
Generalized Myasthenia Gravis
Min. Age
18
Years
Max. Age
-
Who Can Join?
All
Status
Active, not recruiting
Inclusion criteria
- Study participant must meet one of the following:
a) completed MG0003 [NCT03971422]
b) required rescue therapy during the Observation Period in MG0003
or
c) completed at least 6 visits in MG0004 [NCT04124965]
- Body weight ≥35 kg at Baseline (Day 1)
- Study participants may be male or female
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/history of nontuberculous mycobacterial infection (NTMBI)
- Study participant met any mandatory withdrawal or mandatory study drug discontinuation criteria in MG0003, or MG0004, or permanently discontinued study drug in either study
- Study participant intends to have a live vaccination during the course of the study or within 8 weeks following the final 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
Study Medication Description
Study Medication:
rozanolixizumab
Other Descriptive Name:
rozanolixizumab
Placebo
No
Comparator:
No
Refer to a friend
Study Dates
February 2021
Actual Start Date of Enrollment
October 2023
Planned Study Completion Date
General Information
Study ID:
MG0007
EudraCT Number:
2020-003230-20
CT.gov Number:
NCT04650854
Phase:
Phase 3