Actively Recruiting
Phase 4 Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Chinese Participants With Generalized Myasthenia Gravis
Led by UCB Biopharma SRL · Updated on 2026-03-27
40
Participants Needed
11
Research Sites
97 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the study is to assess the clinical efficacy of rozanolixizumab in adult Chinese participants with generalized myasthenia gravis (gMG) in the first Treatment Cycle.
CONDITIONS
Official Title
Phase 4 Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Chinese Participants With Generalized Myasthenia Gravis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years of age or older at the time of signing the informed consent form
- Documented diagnosis of generalized myasthenia gravis (gMG) confirmed at Screening Visit
- Positive record of autoantibodies against acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) documented at Screening Visit
- Myasthenia Gravis Foundation of America (MGFA) Clinical Classification II to IV at Screening Visit
- MG-Activities of Daily Living (MG-ADL) score of at least 3 points from non-ocular symptoms and a Quantitative Myasthenia Gravis (QMG) score of at least 11 at Screening and Baseline visits in the first Treatment Cycle
- Considered for additional treatment by the investigator
- Body weight at least 35 kg at Screening Visit
You will not qualify if you...
- Known hypersensitivity to any components of the study drug or other anti-neonatal Fc receptor medications
- Active infection considered clinically important or unresolved by the investigator
- Known tuberculosis infection, high risk of tuberculosis, latent tuberculosis infection, or history of nontuberculous mycobacterial infection
- Previous treatment with rozanolixizumab drug product
- Receipt of any vaccine within 4 weeks before starting rozanolixizumab or planned vaccination within 2 weeks after last infusion
- Treatment with prohibited immunosuppressants, biologics, or other therapies within restricted treatment-free periods
- Severe weakness (Grade 3 on MG-ADL scale) affecting oropharyngeal or respiratory muscles, or myasthenic crisis or impending crisis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Mg0033 20040
Beijing, China
Actively Recruiting
2
Mg0033 20295
Changsha, China
Actively Recruiting
3
Mg0033 20348
Fuzhou, China
Actively Recruiting
4
Mg0033 20269
Guangzhou, China
Actively Recruiting
5
Mg0033 20185
Jinan, China
Actively Recruiting
6
Mg0033 20347
Jinan, China
Actively Recruiting
7
Mg0033 20172
Shanghai, China
Actively Recruiting
8
Mg0033 20184
Shenzhen, China
Actively Recruiting
9
Mg0033 20204
Suzhou, China
Actively Recruiting
10
Mg0033 20180
Wuhan, China
Actively Recruiting
11
Mg0033 20349
Xuzhou SHI, China
Actively Recruiting
Research Team
U
UCB Cares
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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