NMOSDPhase 3NCT07557420
Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Study of Ravulizumab in Chinese Adults With Neuromyelitis Optica Spectrum Disorder (NMOSD)
A Phase 3 study testing Ravulizumab in people with NMOSD and Neuromyelitis Optica Spectrum Disorder, run by Alexion Pharmaceuticals, Inc. at 10 sites in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- NMOSD, Neuromyelitis Optica Spectrum Disorder
- 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
- 19 participants
- Where
- 10 sitesChina
- Study dates
- 20 Jul 2026to 19 Sep 2028
- 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
- Diagnosis: NMOSD per 2015 international consensus criteria, and anti AQP4 antibody positive at Screening.
- Disease activity: ≥1 attack/relapse in the past 12 months.
- Disability: EDSS ≤7.
- Background therapy: If on IST and/or oral corticosteroids, participant should be on a stable maintenance regimen prior to Screening and plan to remain stable during the study unless relapse occurs. (Detailed agent specific duration/dose rules to be confirmed at screening.)
- Body weight: ≥40 kg.
- Vaccinated against meningococcal infections from serogroups A, C, W, Y (and B where available) within the 3 years prior to study intervention administration on Day 1.
Who cannot join
- Pregnancy/lactation: Pregnant, breastfeeding, or intending to conceive during the study.
- Infection risk: History of meningococcal disease or unresolved meningococcal disease, active systemic infection within 14 days, or fever ≥38°C within 7 days before Day 1.
- Hypersensitivity: To murine proteins or ravulizumab excipients.
- Serious comorbidities: Any condition that in the Investigator's judgment adds risk or interferes with participation/assessment.
- Viral infections: Known HIV, active HBV, or active HCV.
- Prior/concomitant immunomodulatory treatments:
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- B cell-depleting therapy (e.g., rituximab, inebilizumab) within 3 months before Screening.
- Mitoxantrone or satralizumab within 3 months before Screening.
- IVIg within 3 weeks before Screening.
- Any prior or current complement inhibitor.
- 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
- Not yet recruiting
Research Site
Beijing, 100016
- Not yet recruiting
Research Site
Beijing, 100176
- Not yet recruiting
Research Site
Chengdu, 610016
- Not yet recruiting
Research Site
Dongguan, 523059
- Not yet recruiting
Research Site
Jinan, 250012
- Recruiting
Research Site
Shanghai, 201107
- Not yet recruiting
Research Site
Shijiazhuang, 050001
- Not yet recruiting
Research Site
Taiyuan, 030001
- Not yet recruiting
Research Site
Wenzhou, 325000
- Not yet recruiting
Research Site
Wuhan, 430030
About this study
Official title: A Phase 3b, Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Ravulizumab in Chinese Adult Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)
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).
- Conditions
- NMOSD, Neuromyelitis Optica Spectrum Disorder
- Being tested
- Ravulizumab
- Keywords
- Ravulizumab, NMOSD, Neuromyelitis optica spectrum disorder
- Medical subject headings
- Neuromyelitis Optica
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 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. Receives: Drug: Ravulizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjudicated On-Trial Annualized Relapse Rate (ARR)
Measured: Baseline up to Week 50
Secondary outcomes (9)
Number of Participants With Clinically Important Change From Baseline in Hauser Ambulation Index (HAI) Score
Measured: Baseline up to Week 50
Number of Participants With Clinically Important Worsening From Baseline in Expanded Disability Status Scale (EDSS) Score
Measured: Baseline up to Week 50
Change From Baseline in European Quality of Life Health 5-item Questionnaire (EQ-5D) Index Score
Measured: Baseline, Week 50
Change From Baseline in EQ-5D Visual Analog Scale (VAS) Score
Measured: 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)
Measured: Baseline up to Week 50
Serum Ravulizumab Concentration
Measured: Day 1 to Day 351
Change From Baseline in Serum Free Complement Component 5 (C5) Concentration
Measured: Baseline Up to Day 351
Number of Participants With Anti-Drug Antibodies (ADAs)
Measured: Day 1 up to Day 351
Number of Participants With Neutralizing Antibodies (NAb)
Measured: Day 1 up to Day 351
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start20 Jul 2026
- Primary completion19 Sep 2028 (estimated)
- Study completion19 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NMOSDStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 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
- NCT07557420
- Sponsor's protocol ID
- D9282C00006
- Other IDs
- ALXN1210-NMO-324
- Status last verified
- Sep 2026
- First submitted
- 23 Apr 2026
- Last updated
- 11 Sep 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Ravulizumab in Chinese Adult Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)
- ClinicalTrials.gov ID
- NCT07557420
- Acronym / sponsor ID
- D9282C00006
- Conditions
- NMOSD, Neuromyelitis Optica Spectrum Disorder
- Keywords
- Ravulizumab, NMOSD, Neuromyelitis optica spectrum disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- 19 Sep 2028 (estimated)
- Study completion
- 19 Sep 2028 (estimated)
- First posted
- 29 Apr 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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ravulizumab | Experimental | Drug: RavulizumabParticipants 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. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis: NMOSD per 2015 international consensus criteria, and anti AQP4 antibody positive at Screening.
- Disease activity: ≥1 attack/relapse in the past 12 months.
- Disability: EDSS ≤7.
- Background therapy: If on IST and/or oral corticosteroids, participant should be on a stable maintenance regimen prior to Screening and plan to remain stable during the study unless relapse occurs. (Detailed agent specific duration/dose rules to be confirmed at screening.)
- Body weight: ≥40 kg.
Key exclusion criteria (11 listed)
- Pregnancy/lactation: Pregnant, breastfeeding, or intending to conceive during the study.
- Infection risk: History of meningococcal disease or unresolved meningococcal disease, active systemic infection within 14 days, or fever ≥38°C within 7 days before Day 1.
- Hypersensitivity: To murine proteins or ravulizumab excipients.
- Serious comorbidities: Any condition that in the Investigator's judgment adds risk or interferes with participation/assessment.
- Viral infections: Known HIV, active HBV, or active HCV.
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
Adjudicated On-Trial Annualized Relapse Rate (ARR)
Time frame: Baseline up to Week 50
9 secondary outcomes
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
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 11 Sep 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 NMOSD and Neuromyelitis Optica Spectrum Disorder, 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 11 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 11 Sep 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?
Adjudicated On-Trial Annualized Relapse Rate (ARR) (time frame: Baseline up to Week 50). 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 11 Sep 2026.