A study to evaluate rozanolixizumab in study participants with generalized myasthenia gravis
- Conditions
- Generalized Myasthenia Gravis
- Registration Number
- JPRN-jRCT2021200038
- Lead Sponsor
- SUGIHARA Kazuhiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 18
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
- 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 & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Percentage of participants with treatment-emergent adverse events (TEAEs)<br>2. Percentage of participants with (TEAEs) leading to permanent withdrawal of investigational medicinal product (IMP)
- Secondary Outcome Measures
Name Time Method