Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

Phase 4 Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Chinese Participants 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

Phase 4 Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Chinese Participants With Generalized Myasthenia Gravis (NCT07246564) is a Phase 4 interventional studying Myasthenia Gravis, sponsored by UCB Biopharma SRL. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 40 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Study participant must be ≥18 years of age at the time of signing the willing to sign a consent form 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 Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Rozanolixizumab

Subcutaneous infusion

Locations (11)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Mg0033 20040

Beijing, China

Mg0033 20295

Changsha, China

Mg0033 20348

Fuzhou, China

Mg0033 20269

Guangzhou, China

Mg0033 20185

Jinan, China

Mg0033 20347

Jinan, China

Mg0033 20172

Shanghai, China

Mg0033 20184

Shenzhen, China

Mg0033 20204

Suzhou, China

Mg0033 20180

Wuhan, China

Mg0033 20349

Xuzhou SHI, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07246564), the sponsor (UCB Biopharma SRL), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07246564 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07246564?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07246564?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07246564. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07246564. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.