Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
UCB Biopharma SRL
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Study participant must meet one of the following:
1. completed MG0003 \[NCT03971422\]
2. required rescue therapy during the Observation Period in MG0003 or
3. completed at least 6 visits in MG0004 \[NCT04124965\]
Body weight ≥35 kg at Baseline (Day 1)
Study participants may be male or female
You may not be if
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
Clareo Health | A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis
