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

An Open-label, Single-arm, Multi-center, Interventional Study to Evaluate the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Ravulizumab in Chinese Adult Patients With Generalized Myasthenia Gravis (gMG)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07596784
Enrollment
20
Registered
2026-05-19
Start date
2026-07-20
Completion date
2027-08-17
Last updated
2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Myasthenia Gravis, gMG

Keywords

generalized myasthenia gravis, gMG, ravulizumab

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).

Interventions

DRUGRavulizumab

Participants will receive ravulizumab via intravenous (IV) infusion.

Sponsors

Alexion Pharmaceuticals, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
Change From Baseline in Quantitative Myasthenia gravis (QMG) Total Score at Week 26Baseline, Week 26
Number of Participants With Reduction by >=5 Points From Baseline in QMG Total Score at Week 26Baseline up to Week 26
Number of Participants With Reduction by >=3 Points From Baseline in MG-ADL Total Score at Week 26Baseline up to Week 26
Change From Baseline in Revised Myasthenia Gravis Quality of Life 15-Item Scale (MG-QoL15r) Total Score at Week 26Baseline, Week 26
Change From Baseline in Neurological Quality of Life (Neuro-QoL) Fatigue Score at Week 26Baseline, Week 26
Serum Ravulizumab ConcentrationDay 1 up to Week 26
Change From Baseline in Serum Free C5 ConcentrationBaseline, Week 34
Number of Participants With Anti-Drug Antibodies (ADAs)Baseline up to Week 34
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interests (AESIs)Baseline up to Week 34

Countries

China

Contacts

CONTACTAlexion Pharmaceuticals, Inc. (Sponsor)
clinicaltrials@alexion.com1-855-752-2356

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026