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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07596784
- Acronym / sponsor ID
- D9281C00003
- Conditions
- Generalized Myasthenia Gravis, gMG
- Keywords
- generalized myasthenia gravis, gMG, ravulizumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jul 2026 (actual)
- Primary completion
- 24 Aug 2027 (estimated)
- Study completion
- 24 Aug 2027 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ravulizumab | Experimental | Drug: RavulizumabParticipants will receive ravulizumab for up to 26 weeks. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (24 listed)
- Thymic disease:
- Infection risk:
- Safety/medical status:
- Prior/Concomitant Therapy
- Key labs:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RavulizumabParticipants will receive ravulizumab via intravenous (IV) infusion. | Drug | Ravulizumab |
Primary outcome
Change From Baseline in Myasthenia Gravis Activities of Daily Living Profile (MG-ADL) Total Score at Week 26
Time frame: Baseline, Week 26
9 secondary outcomes
Change From Baseline in Quantitative Myasthenia gravis (QMG) Total Score at Week 26
Time frame: Baseline, Week 26
Number of Participants With Reduction by >=5 Points From Baseline in QMG Total Score at Week 26
Time frame: Baseline up to Week 26
Number of Participants With Reduction by >=3 Points From Baseline in MG-ADL Total Score at Week 26
Time frame: 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
Time frame: Baseline, Week 26
Change From Baseline in Neurological Quality of Life (Neuro-QoL) Fatigue Score at Week 26
Time frame: Baseline, Week 26
Serum Ravulizumab Concentration
Time frame: Day 1 up to Week 26
Change From Baseline in Serum Free C5 Concentration
Time frame: Baseline, Week 34
Number of Participants With Anti-Drug Antibodies (ADAs)
Time frame: 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)
Time frame: Baseline up to Week 34
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ravulizumab in people with Generalized Myasthenia Gravis and gMG, run by Alexion Pharmaceuticals, Inc. at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexion Pharmaceuticals, Inc. (Sponsor) (1-855-752-2356, clinicaltrials@alexion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Myasthenia Gravis Activities of Daily Living Profile (MG-ADL) Total Score at Week 26 (time frame: Baseline, Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.