NCT04650854CompletedPhase 3
A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis
An Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 165 (actual)
- First submitted
- 5 Nov 2020
- Start date
- 3 Feb 2021
- Primary completion date
- 25 Jan 2024
- Lead sponsor
- UCB Biopharma SRL
- Diseases
- Myasthenia gravis
- NCT number
- NCT04650854
- EudraCT number
- 2020-003230-20
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 165
- From 3 Feb 2021 to the primary completion date, 25 Jan 2024
- 69 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Study participant met any mandatory withdrawal or mandatory study drug discontinuation criteria in MG0003, or MG0004, or permanently discontinued study drug in either study
Other illness
- 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)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (69)
Sites in registry order. Pick your city on the disease page to sort them by distance.
Related publications
- Long-term use of rozanolixizumab in generalised myasthenia gravis: final pooled analysis of the phase III MycarinG study and two open-label extensions.Ther Adv Neurol Disord · 2026 · PMID 42388397
This page is information, not medical advice. Discuss any trial with your doctor.