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

Completed · Phase 3

Conditions studied: Generalized Myasthenia Gravis

In brief

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).

Key facts

Study ID

NCT04650854

Run by

UCB Biopharma SRL

People needed

165

Starts

2021-02-03

Expected to finish

2024-01-25

Last updated by the study team

2025-04-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Study participant must meet one of the following:
• completed MG0003 [NCT03971422]
• required rescue therapy during the Observation Period in MG0003 or
• 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 qualify 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

Where it is running

• Mg0007 50099 — San Francisco, California, United States
• Mg0007 50122 — Miami, Florida, United States
• Mg0007 50120 — Miami, Florida, United States
• Mg0007 50073 — Tampa, Florida, United States
• Mg0007 50075 — Augusta, Georgia, United States
• Mg0007 50323 — Honolulu, Hawaii, United States
• Mg0007 50114 — Indianapolis, Indiana, United States
• Mg0007 50121 — Lexington, Kentucky, United States
• Mg0007 50077 — New York, New York, United States
• Mg0007 50090 — Winston-Salem, North Carolina, United States
• Mg0007 50096 — Philadelphia, Pennsylvania, United States
• Mg0007 50113 — Houston, Texas, United States
• Mg0007 50071 — Edmonton, Canada
• Mg0007 50066 — Montreal, Canada
• Mg0007 50124 — Montreal, Canada
• Mg0007 50070 — Québec, Canada
• Mg0007 50069 — Toronto, Canada
• Mg0007 40125 — Ostrava - Poruba, Czechia
• Mg0007 40124 — Prague, Czechia
• Mg0007 40128 — Aalborg, Denmark
• Mg0007 40127 — Aarhus, Denmark
• Mg0007 40126 — Copenhagen, Denmark
• Mg0007 40129 — Bordeaux, France
• Mg0007 40360 — Limoges, France
• Mg0007 50092 — Orange, California, United States

Full record on ClinicalTrials.gov

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