Rozanolixizumab treatment for adult Chinese patients with generalized myasthenia gravis

An Open-label, Prospective, Single-arm Study Assessing the Efficacy and Safety of Rozanolixizumab in Adult Chinese Participants With Generalized Myasthenia Gravis

This trial will test whether the antibody drug rozanolixizumab can help adults in China who have generalized myasthenia gravis feel and function better.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: UCB Pharma (Industry-sponsored)
• Drugs / interventions: rozanolixizumab
• Locations: 11 sites (Beijing and 10 other locations)
• Trial ID: NCT07246564 on ClinicalTrials.gov

What this trial studies

This Phase 4 interventional study gives rozanolixizumab to adults in China with antibody-positive generalized myasthenia gravis during the first treatment cycle and monitors safety and symptom change. Eligible participants must be AChR- or MuSK-antibody positive, have MGFA class II–IV disease, and meet minimum MG-ADL and QMG scores at screening and baseline. Clinical effect will be measured using standard myasthenia scales and close safety monitoring throughout the treatment period. The study is sponsored by UCB Biopharma and conducted at several clinical sites in China.

Who should consider this trial

Good fit: Adults (≥18 years) in China with generalized myasthenia gravis who are AChR- or MuSK-antibody positive, have MGFA class II–IV disease, and meet the MG-ADL and QMG score thresholds are the intended participants.

Not a fit: People with purely ocular myasthenia gravis, seronegative disease, those who do not meet the symptom severity thresholds, or those under 18 or under 35 kg are unlikely to qualify or benefit from this protocol.

Why it matters

Potential benefit: If successful, the drug could reduce muscle weakness and improve daily function for adult Chinese patients with antibody-positive gMG.

How similar studies have performed: Other trials of FcRn-blocking therapies, and prior clinical work with rozanolixizumab, have shown reductions in pathogenic IgG and symptom improvement in gMG, so this approach has supporting evidence.

Eligibility criteria

Inclusion Criteria:

* Study participant must be ≥18 years of age at the time of signing the informed consent form (ICF)
* Study participant has documented diagnosis of generalized myasthenia gravis (gMG) at the Screening Visit based on study participant's history and supported by previous evaluation
* Study participant has a confirmed positive record of autoantibodies against acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) documented in the medical history at the Screening Visit
* Study participant has Myasthenia Gravis Foundation of America (MGFA) Clinical Classification II to IV at Screening Visit.
* Study participant with a myasthenia gravis-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 the Screening and Baseline visits in the first Treatment Cycle.
* Study participant is considered for additional treatment by the investigator
* Body weight ≥35kg at the Screening Visit

Exclusion Criteria:

* Study participant has a known hypersensitivity to any components of the study drug or any other anti-neonatal Fc receptor (anti-FcRn) medications
* Study participant has a clinically important active infection including unresolved or not adequately treated infection in the opinion of the investigator
* 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 has previously received rozanolixizumab drug product
* Study participant has received any vaccine in the 4 weeks prior to the initiation of rozanolixizumab treatment or intends to receive any vaccine within 2 weeks after the last infusion of rozanolixizumab. Note: For participants that are on rozanolixizumab treatment, vaccination with live or live-attenuated vaccines is not recommended. During the whole study period, all other vaccines should take place at least 2 weeks after the last infusion of a Treatment Cycle and 4 weeks before initiating the next cycle
* 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) weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis. Note: Impending Crisis is defined as bulbar or respiratory symptoms of a patient who significantly worsens in a short time (≤2 weeks) and meet MGFA IVb or score 3 in one QMG bulbar muscle item, or score 2 in respiratory muscle item, or bulbar+respiratory items score ≥4

Where this trial is running

Beijing and 10 other locations

• Mg0033 20040 — Beijing, China (Recruiting)
• Mg0033 20295 — Changsha, China (Recruiting)
• Mg0033 20348 — Fuzhou, China (Recruiting)
• Mg0033 20269 — Guangzhou, China (Recruiting)
• Mg0033 20185 — Jinan, China (Recruiting)
• Mg0033 20347 — Jinan, China (Recruiting)
• Mg0033 20172 — Shanghai, China (Recruiting)
• Mg0033 20184 — Shenzhen, China (Recruiting)
• Mg0033 20204 — Suzhou, China (Recruiting)
• Mg0033 20180 — Wuhan, China (Recruiting)
• Mg0033 20349 — Xuzhou SHI, China (Recruiting)

Study contacts

• Study coordinator: UCB Cares

Conditions Myasthenia Gravis; Rozanolixizumabg, gMG