Phase 4 Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Chinese Participants With Generalized Myasthenia Gravis

Last updated: May 21, 2026
Sponsor: UCB Biopharma SRL
Overall Status: Active - Recruiting

Phase

4

Condition

Polymyositis (Inflammatory Muscle Disease)

Neuropathy

Treatment

Rozanolixizumab

Clinical Study ID

NCT07246564
MG0033
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Study participant must be ≥18 years of age at the time of signing the informedconsent form (ICF)

  • Study participant has documented diagnosis of generalized myasthenia gravis (gMG) atthe Screening Visit based on study participant's history and supported by previousevaluation

  • Study participant has a confirmed positive record of autoantibodies againstacetylcholine receptor (AChR) or muscle-specific kinase (MuSK) documented in themedical history at the Screening Visit

  • Study participant has Myasthenia Gravis Foundation of America (MGFA) ClinicalClassification II to IV at Screening Visit.

  • Study participant with a myasthenia gravis-activities of daily living (MG-ADL) scoreof at least 3 points from non-ocular symptoms and a quantitative myasthenia gravis (QMG) score of at least 11 at the Screening and Baseline visits in the firstTreatment Cycle.

  • Study participant is considered for additional treatment by the investigator

  • Body weight ≥35kg at the Screening Visit

Exclusion

Exclusion Criteria:

  • Study participant has a known hypersensitivity to any components of the study drugor any other anti-neonatal Fc receptor (anti-FcRn) medications

  • Study participant has a clinically important active infection including unresolvedor not adequately treated infection in the opinion of the investigator

  • Study participant with a known tuberculosis (TB) infection, at high risk ofacquiring TB infection, or latent tuberculosis infection (LTBI), or current/historyof nontuberculous mycobacterial infection (NTMBI)

  • Study participant has previously received rozanolixizumab drug product

  • Study participant has received any vaccine in the 4 weeks prior to the initiation ofrozanolixizumab treatment or intends to receive any vaccine within 2 weeks after thelast infusion of rozanolixizumab. Note: For participants that are on rozanolixizumabtreatment, vaccination with live or live-attenuated vaccines is not recommended.During the whole study period, all other vaccines should take place at least 2 weeksafter the last infusion of a Treatment Cycle and 4 weeks before initiating the nextcycle

  • Study participant has been treated with prohibited immunosuppressants, biologics,and other therapies within the timeframe shorter than the treatment-free period

  • Study participant with severe (defined as Grade 3 on the MG-ADL scale) weaknessaffecting oropharyngeal or respiratory muscles, or who has myasthenic crisis orimpending crisis. Note: Impending Crisis is defined as bulbar or respiratorysymptoms of a patient who significantly worsens in a short time (≤2 weeks) and meetMGFA IVb or score 3 in one QMG bulbar muscle item, or score 2 in respiratory muscleitem, or bulbar+respiratory items score ≥4

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Rozanolixizumab
Phase: 4
Study Start date:
December 01, 2025
Estimated Completion Date:
October 15, 2027

Connect with a study center

  • Mg0033 20040

    Beijing,
    China

    Active - Recruiting

  • Mg0033 20261

    Changchun,
    China

    Active - Recruiting

  • Mg0033 20295

    Changsha,
    China

    Active - Recruiting

  • Mg0033 20295

    Changsha 1815577,
    China

    Site Not Available

  • Mg0033 20348

    Fuzhou,
    China

    Active - Recruiting

  • Mg0033 20348

    Fuzhou 1810821,
    China

    Site Not Available

  • Mg0033 20269

    Guangzhou,
    China

    Active - Recruiting

  • Mg0033 20185

    Jinan,
    China

    Active - Recruiting

  • Mg0033 20347

    Jinan,
    China

    Active - Recruiting

  • Mg0033 20185

    Jinan 1805753,
    China

    Active - Recruiting

  • Mg0033 20347

    Jinan 1805753,
    China

    Site Not Available

  • Mg0033 20172

    Shanghai,
    China

    Active - Recruiting

  • Mg0033 20172

    Shanghai 1796236,
    China

    Site Not Available

  • Mg0033 20184

    Shenzhen,
    China

    Active - Recruiting

  • Mg0033 20184

    Shenzhen 1795565,
    China

    Site Not Available

  • Mg0033 20204

    Suzhou,
    China

    Active - Recruiting

  • Mg0033 20204

    Suzhou 1886760,
    China

    Site Not Available

  • Mg0033 20180

    Wuhan,
    China

    Active - Recruiting

  • Mg0033 20349

    Xuzhou SHI,
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.