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

NCT04650854

CompletedPhase 3

Sponsor: UCB Biopharma SRL

Conditions: Generalized Myasthenia Gravis

Interventions: Rozanolixizumab

Countries: United States, Canada, Czechia, Denmark, France, Georgia, Germany, Italy

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (69)
  • Orange, California, United States
  • San Francisco, California, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Tampa, Florida, United States
  • Augusta, Georgia, United States
  • Honolulu, Hawaii, United States
  • Indianapolis, Indiana, United States
  • Lexington, Kentucky, United States
  • New York, New York, United States
  • Winston-Salem, North Carolina, United States
  • Philadelphia, Pennsylvania, United States
  • Houston, Texas, United States
  • Edmonton, Canada
  • Montreal, Canada
  • Montreal, Canada
  • Québec, Canada
  • Toronto, Canada
  • Ostrava - Poruba, Czechia
  • Prague, Czechia
  • Aalborg, Denmark
  • Aarhus, Denmark
  • Copenhagen, Denmark
  • Bordeaux, France
  • Limoges, France
  • Nice, France
  • Paris, France
  • Strasbourg, France
  • Tbilisi, Georgia
  • Tbilisi, Georgia
  • + 39 more on CT.gov