Ravulizumab in Chinese adults with NMOSD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial evaluates the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ravulizumab in Chinese adults with anti-AQP4 antibody–positive NMOSD. Eligible participants have had attacks in the prior year and a stable background therapy, with body weight at least 40 kg and meningococcal vaccination. The study will monitor relapses, disability progression, and immune responses while assessing drug levels and effects on the immune system. Sites are located in Beijing and Chengdu. Lead sponsor is Alexion Pharmaceuticals, with no listed collaborators.

Why it matters

Who can join: the full rules

Key Inclusion (essential)

* 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.

Key Exclusion (essential)

* 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:

  * 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.

Where it's running

• Research Site
  Shanghai, China Recruiting
• Research Site
  Beijing, China Not yet recruiting
• Research Site
  Beijing, China Not yet recruiting
• Research Site
  Chengdu, China Not yet recruiting
• Research Site
  Dongguan, China Not yet recruiting
• Research Site
  Jinan, China Not yet recruiting

Study contacts

• Study coordinator: Alexion Pharmaceuticals, Inc. (Sponsor)
• Email: clinicaltrials@alexion.com
• Phone: 1-855-752-2356

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  This study tests whether rituximab or one of four other approved medicines is better at preventing NMOSD relapses in adults who have AQP4-IgG.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.