A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis

• Status: Enrolling by invitation
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Biopharma SRL
• Treatments: Rozanolixizumab

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