Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04650854). StuddyBuddy aggregates publicly available trial information.