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Completed
NCT04650854
A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis
Conditions: Generalized Myasthenia Gravis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 165
Sponsor: UCB Biopharma SRL
Location: Mg0007 50092 Orange California
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).
Eligibility Criteria
Inclusion Criteria:
* 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
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
Source: ClinicalTrials.gov (NCT04650854). StuddyBuddy aggregates publicly available trial information.