A Phase 3 interventional study of Ravulizumab in NMOSD and Neuromyelitis Optica Spectrum Disorder, 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 2026-09-11.
Sponsored by Alexion Pharmaceuticals, Inc. (part of AstraZeneca) · Phase 3, Interventional, and Treatment
The primary objective of this study is to confirm the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ravulizumab in the treatment of Chinese adults with anti-aquaporin-4 (AQP4) antibody (Ab) + neuromyelitis optica spectrum disorder (NMOSD).
178 studies on the registry are indexed under Neuromyelitis Optica; 78 are open to participants now.
This study's planned enrollment of 19 is below the median of 29 across 108 interventional studies indexed under Neuromyelitis Optica.
Browse Neuromyelitis Optica studies →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.
Key Inclusion (essential)
Key Exclusion (essential)
Prior/concomitant immunomodulatory treatments:
Note: Other protocol-defined criteria may apply and should be verified during full eligibility review.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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 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 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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a weight-based loading dose of ravulizumab on Day 1, followed by a weight-based maintenance treatment dose on Day 15 and every 8 weeks (q8w) thereafter for up to 50 weeks.
Drug: Ravulizumab
Participants will receive ravulizumab via intravenous (IV) infusion.
Adjudicated On-Trial Annualized Relapse Rate (ARR)
Time frame: Baseline up to Week 50
Number of Participants With Clinically Important Change From Baseline in Hauser Ambulation Index (HAI) Score
Time frame: Baseline up to Week 50
Number of Participants With Clinically Important Worsening From Baseline in Expanded Disability Status Scale (EDSS) Score
Time frame: Baseline up to Week 50
Change From Baseline in European Quality of Life Health 5-item Questionnaire (EQ-5D) Index Score
Time frame: Baseline, Week 50
Change From Baseline in EQ-5D Visual Analog Scale (VAS) Score
Time frame: Baseline, Week 50
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 50
Serum Ravulizumab Concentration
Time frame: Day 1 to Day 351
Change From Baseline in Serum Free Complement Component 5 (C5) Concentration
Time frame: Baseline Up to Day 351
Number of Participants With Anti-Drug Antibodies (ADAs)
Time frame: Day 1 up to Day 351
Number of Participants With Neutralizing Antibodies (NAb)
Time frame: Day 1 up to Day 351
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.
Started Jul 2026 (actual). Primary completion is estimated for Sep 2028, 25 months after the start.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Ravulizumab
Alexion Pharmaceuticals, Inc. →