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

NCT07246564 | Recruiting Phase 4

• 1 other identifier: MG0033
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Myasthenia Gravis

Keywords

Rozanolixizumabg, gMG

Outcome Measures

Primary Outcomes (1)

• Change from Baseline to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) score in the first Treatment Cycle

  The total MG-ADL score is obtained by summing the responses to each individual item (8 items; Grades: 0, 1, 2, 3). The score ranges from 0 to 24, with a higher score indicating more disability. A positive change indicates worsening and a negative change indicates improvement.

  Baseline to Day 43 (in first treatment cycle)

Secondary Outcomes (7)

• MG-ADL responder (≥2.0-point improvement from Baseline) at Day 43 in the first Treatment Cycle

  Baseline to Day 43 (in first treatment cycle)

• Change from Baseline to Day 43 in Myasthenia Gravis-Composite (MG-C) score within first 6 week treatment cycle

  Baseline to Day 43 (in first treatment cycle)

• Change from Baseline to Day 43 in Quantitative Myasthenia Gravis (QMG) score within first 6-week treatment cycle

  Baseline to Day 43 (in first treatment cycle)

• Change from Baseline to Day 43 in Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Muscle Weakness Fatigability' score within first 6-week treatment cycle

  Baseline to Day 43 (in first treatment cycle)

• Change from Baseline to Day 43 in MG Symptoms PRO 'Physical Fatigue' score within first 6-week treatment cycle

  Baseline to Day 43 (in first treatment cycle)

Study Arms (1)

Rozanolixizumab

EXPERIMENTAL

Participants will receive 6 dose per cycle of subcutaneous infusion of rozanolixizumab

Drug: Rozanolixizumab

Interventions

Rozanolixizumab DRUG

Subcutaneous infusion

Rozanolixizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (11)

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

MeSH Terms

Conditions

Myasthenia Gravis

Interventions

rozanolixizumab

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• UCB Cares

  001 844 599 22733 (UCB)

  STUDY DIRECTOR

Central Study Contacts

UCB Cares

CONTACT

+18445992273; ucbcares@ucb.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): October 15, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
• Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.

Locations

CN (11)