ClinicalTrials.gg
RecruitingNCT07596784Updated Oct 21, 2026

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

A Phase 3 interventional study of Ravulizumab in Generalized Myasthenia Gravis and gMG, sponsored by Alexion Pharmaceuticals, Inc.. Recruiting at 10 sites in China. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Alexion Pharmaceuticals, Inc. (part of AstraZeneca) · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Updated Oct 21, 2026Site recruiting status changedStart date moved+2 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 130 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Generalized Myasthenia Gravis
  • gMG

Browse trials for

Keywords

  • generalized myasthenia gravis
  • gMG
  • ravulizumab
03

In context

Myasthenia Gravis

330 studies on the registry are indexed under Myasthenia Gravis; 144 are open to participants now.

This study's planned enrollment of 20 is below the median of 44 across 217 interventional studies indexed under Myasthenia Gravis.

Browse Myasthenia Gravis studies →

Lead sponsor

Alexion Pharmaceuticals, Inc. is the lead sponsor of 255 studies on the registry; 23 are open to participants now.

Of its 101 completed or terminated interventional studies of FDA-regulated products, 75 (74%) have results posted.

First submitted after Alexion Pharmaceuticals, Inc. became part of AstraZeneca.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 130 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 criteria

Exclusion (key)

  • Thymic disease:

    • Untreated thymic /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
    • , active (HBsAg+ or anti-HBc+ with anti-HBs-), or active (unless documented successful treatment/SVR)
  • Safety/medical status:

    • 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:

    • >2× , direct >2× ULN.
    • \<30 mL/min/1.73 m² or on dialysis.
    • Any other lab abnormality making participation unsafe.

Note: Other protocol-defined criteria may apply and should be verified during full eligibility review.

Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Ravulizumab

    Participants will receive ravulizumab for up to 26 weeks.

    Drug: Ravulizumab

Interventions

  • Participants will receive ravulizumab via intravenous (IV) infusion.

06

What researchers measure

Primary outcomes

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

    Time frame: Baseline, Week 26

Secondary outcomes

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

    Time frame: Baseline, Week 26

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

    Time frame: Baseline up to Week 26

  3. 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

  4. 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

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

    Time frame: Baseline, Week 26

  6. Serum Ravulizumab Concentration

    Time frame: Day 1 up to Week 26

  7. Change From Baseline in Serum Free C5 Concentration

    Time frame: Baseline, Week 34

  8. Number of Participants With Anti-Drug Antibodies (ADAs)

    Time frame: Baseline up to Week 34

  9. 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

07

Study locations

8 of 10 sites recruiting
  • Research Site
    Beijing, 100053, China
    Recruiting
  • Research Site
    Changchun, 130021, China
    Not yet recruiting
  • Research Site
    Fuzhou, 350001, China
    Recruiting
  • Research Site
    Jinan, 250012, China
    Recruiting
  • Research Site
    Shanghai, 200040, China
    Recruiting
  • Research Site
    Shijiazhuang, 050000, China
    Recruiting
  • Research Site
    Taiyuan, 030001, China
    Recruiting
  • Research Site
    Tianjin, 300050, China
    Recruiting
  • Research Site
    Wuhan, 430030, China
    Not yet recruiting
  • Research Site
    Zhengzhou, 450000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Aug 2027, 12 months after the start.

Of 43 industry-sponsored phase 3 interventional studies under Myasthenia Gravis, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 39. This study's planned 12 months is below that.

Counting every sponsor, half of 52 studies reached it within 30 months; a quarter within 20 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
May 13, 2026
First posted
May 19, 2026
StartActual
Jul 27, 2026
Primary completionEst.
Aug 24, 2027
CompletionEst.
Aug 24, 2027
Last update
Oct 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
3 sites changed recruiting status (3 now recruiting)
Show 3 sites
  • Research Site · Fuzhou, ChinaNot yet recruiting→Recruiting
  • Research Site · Jinan, ChinaNot yet recruiting→Recruiting
  • Research Site · Tianjin, ChinaNot yet recruiting→Recruiting
Oct 21, 2026
Start date
Jul 20, 2026→Jul 27, 2026
Oct 21, 2026
Primary completion
Aug 17, 2027→Aug 24, 2027
Oct 21, 2026
Study completion
Aug 17, 2027→Aug 24, 2027
Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    3 sites changed recruiting status (3 now recruiting)
    Show 3 sites
    • Research Site · Fuzhou, ChinaNot yet recruiting→Recruiting
    • Research Site · Jinan, ChinaNot yet recruiting→Recruiting
    • Research Site · Tianjin, ChinaNot yet recruiting→Recruiting
    Start date Jul 20, 2026→Jul 27, 2026
    Primary completion Aug 17, 2027→Aug 24, 2027
    Study completion Aug 17, 2027→Aug 24, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07596784
Responsible party
Sponsor
First posted
May 19, 2026
Start date
Jul 27, 2026
Primary completion
Aug 24, 2027 (estimated)
Completion
Aug 24, 2027 (estimated)
Last update
Oct 21, 2026

Study contacts

Alexion Pharmaceuticals, Inc. (Sponsor)
Contact
clinicaltrials@alexion.com
1-855-752-2356

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Ravulizumab

Start the discussion