Generalized Myasthenia GravisPhase 3NCT07596784
Efficacy and Safety of Ravulizumab in Chinese Adults Participants With Generalized Myasthenia Gravis (gMG)
A Phase 3 study testing Ravulizumab in people with Generalized Myasthenia Gravis and gMG, run by Alexion Pharmaceuticals, Inc. at 10 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Generalized Myasthenia Gravis, gMG
- What is being tested?
- Ravulizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 10 sitesChina
- Study dates
- 27 Jul 2026to 24 Aug 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Research Site
Beijing, 100053
- Not yet recruiting
Research Site
Changchun, 130021
- Recruiting
Research Site
Fuzhou, 350001
- Recruiting
Research Site
Jinan, 250012
- Recruiting
Research Site
Shanghai, 200040
- Recruiting
Research Site
Shijiazhuang, 050000
- Recruiting
Research Site
Taiyuan, 030001
- Recruiting
Research Site
Tianjin, 300050
- Not yet recruiting
Research Site
Wuhan, 430030
- Recruiting
Research Site
Zhengzhou, 450000
About this study
Official title: 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)
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
- Being tested
- Ravulizumab
- Keywords
- generalized myasthenia gravis, gMG, ravulizumab
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RavulizumabDrug
Participants will receive ravulizumab via intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| Ravulizumab | Experimental | Participants will receive ravulizumab for up to 26 weeks. Receives: Drug: Ravulizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Myasthenia Gravis Activities of Daily Living Profile (MG-ADL) Total Score at Week 26
Measured: Baseline, Week 26
Secondary outcomes (9)
Change From Baseline in Quantitative Myasthenia gravis (QMG) Total Score at Week 26
Measured: Baseline, Week 26
Number of Participants With Reduction by >=5 Points From Baseline in QMG Total Score at Week 26
Measured: Baseline up to Week 26
Number of Participants With Reduction by >=3 Points From Baseline in MG-ADL Total Score at Week 26
Measured: 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
Measured: Baseline, Week 26
Change From Baseline in Neurological Quality of Life (Neuro-QoL) Fatigue Score at Week 26
Measured: Baseline, Week 26
Serum Ravulizumab Concentration
Measured: Day 1 up to Week 26
Change From Baseline in Serum Free C5 Concentration
Measured: Baseline, Week 34
Number of Participants With Anti-Drug Antibodies (ADAs)
Measured: 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)
Measured: Baseline up to Week 34
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start27 Jul 2026
- Primary completion24 Aug 2027 (estimated)
- Study completion24 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Myasthenia GravisStudies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596784
- Sponsor's protocol ID
- D9281C00003
- Other IDs
- ALXN1210-MG-326
- Status last verified
- Oct 2026
- First submitted
- 13 May 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.