Efficacy and Safety of Ravulizumab in Chinese Adults Participants With Generalized Myasthenia Gravis (gMG)

NCT07596784 | Not Yet Recruiting Phase 3

• 2 other identifiers: D9281C00003ALXN1210-MG-326
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ravulizumab in Chinese adult participants with Acetylcholine receptor (AChR) + Generalized Myasthenia Gravis (gMG).

Conditions

Generalized Myasthenia Gravis; gMG

Keywords

generalized myasthenia gravis; gMG; ravulizumab

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Myasthenia Gravis Activities of Daily Living Profile (MG-ADL) Total Score at Week 26

  Baseline, Week 26

Secondary Outcomes (9)

• Change From Baseline in Quantitative Myasthenia gravis (QMG) Total Score at Week 26

  Baseline, Week 26

• Number of Participants With Reduction by >=5 Points From Baseline in QMG Total Score at Week 26

  Baseline up to Week 26

• Number of Participants With Reduction by >=3 Points From Baseline in MG-ADL Total Score at Week 26

  Baseline up to Week 26

• Change From Baseline in Revised Myasthenia Gravis Quality of Life 15-Item Scale (MG-QoL15r) Total Score at Week 26

  Baseline, Week 26

• Change From Baseline in Neurological Quality of Life (Neuro-QoL) Fatigue Score at Week 26

  Baseline, Week 26

Study Arms (1)

Ravulizumab

EXPERIMENTAL

Participants will receive ravulizumab for up to 26 weeks.

Drug: Ravulizumab

Interventions

Ravulizumab DRUG

Participants will receive ravulizumab via intravenous (IV) infusion.

Ravulizumab

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Inclusion (key) * Confirmed generalized MG: Diagnosis ≥6 months before screening, anti-AChR antibody positive, and supportive diagnostic evidence (e.g., abnormal SFEMG/RNS or response to anticholinesterase therapy). * Disease severity: MGFA Class II-IV at screening. * Symptoms threshold: MG-ADL ≥6 at screening and on Day 1. * Meningococcal vaccination: Up to date within 3 years or vaccinated before first dose to mitigate risk with complement inhibition. * Body weight: ≥40 kg. * Vaccinated against meningococcal infections within the 3 years prior to, or at the time of, initiating study drug. Exclusion (key) * Thymic disease: * Untreated thymic malignancy/carcinoma/thymoma excluded. * Prior thymic malignancy allowed only if treatment completed \>5 years, no recurrence in last 5 years, and clear CT/MRI within 6 months. * Prior benign thymoma allowed if confirmed benign, treatment \>12 months ago, no recurrence in last 12 months, and clear CT/MRI within 6 months; otherwise follow malignancy rules. * Thymectomy within the last 12 months * Infection risk: * History of meningococcal disease or unresolved infection, or active systemic infection within 14 days of Day 1 excluded. * Persistent/recurrent infections in past 12 months that add risk * HIV, active HBV (HBsAg+ or anti-HBc+ with anti-HBs-), or active HCV (unless documented successful treatment/SVR) * Safety/medical status: * Hypersensitivity to study drug components (including murine proteins) * Recent hospitalization ≥24 hours within 28 days of screening * Substance use disorder per DSM within 12 months. * Recent/other malignancy within 5 years (except as above for thymic). * Prior/Concomitant Therapy * Complement inhibitor within \< 5 half-lives before Day 1. * Human neonatal Fc receptor (FcRn) inhibitor within \< 5 half-lives before Day 1. * Rituximab, ocrelizumab or other B cell-depleting therapy within ≤ 6 months (180 days) before Day 1. * Periodic (chronic) administration of PP/PE, or IVIg as maintenance therapy received or scheduled within ≤ 6 months before Day 1 * Key labs: * ALT \>2× ULN, direct bilirubin \>2× ULN. * eGFR \<30 mL/min/1.73 m² or on dialysis. * Any other clinically significant lab abnormality making participation unsafe. Note: Other protocol-defined criteria may apply and should be verified during full eligibility review.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead

MeSH Terms

Conditions

Myasthenia Gravis

Interventions

ravulizumab

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

Central Study Contacts

Alexion Pharmaceuticals, Inc. (Sponsor)

CONTACT

1-855-752-2356; clinicaltrials@alexion.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): July 30, 2026
• Primary Completion (Estimated): August 27, 2027
• Study Completion (Estimated): August 27, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR