58 Participants Needed

Ravulizumab for Neuromyelitis Optica Spectrum Disorders

Recruiting at 98 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary purpose of this study is to evaluate the efficacy and safety of ravulizumab for the treatment of adult participants with NMOSD.

Are You a Good Fit for This Trial?

Adults with NMOSD who weigh at least 40 kg, have had an attack in the past year, and are on stable immunosuppressive therapy can join. They must use contraception and have a disability score ≤7. People with HIV, recent rituximab or mitoxantrone treatment, IV immunoglobulin use within 3 weeks, or history of meningitis infection cannot participate.

Inclusion Criteria

I have had at least one relapse in the past year.
Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
I weigh at least 40 kilograms.
See 3 more

Exclusion Criteria

I am HIV positive.
I have been treated with a complement inhibitor before.
I have not used IV immunoglobulin in the last 3 weeks.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Primary Treatment

Participants receive open-label ravulizumab via intravenous infusion

26-50 weeks

Long-Term Extension

Participants may continue receiving ravulizumab for up to 2 years or until it is approved/available

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ravulizumab
Trial Overview The trial is testing Ravulizumab's effectiveness and safety for treating adults with Neuromyelitis Optica Spectrum Disorders (NMOSD). Participants will receive this medication to see if it helps prevent relapses of NMOSD symptoms.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: RavulizumabExperimental Treatment1 Intervention
During the Primary Treatment Period, all participants will receive open-label ravulizumab via intravenous (IV) infusion starting on Day 1. The end of the Primary Treatment Period will be triggered when the last enrolled participant completes between 26 and 50 weeks in the study (depending on the number of adjudicated On-Trial Relapse observed). After completion of the Primary Treatment Period, all participants will have the opportunity to continue receiving ravulizumab in the Long-Term Extension Period of the study. For each participant, the Long-Term Extension Period continues for up to 2 years, or until ravulizumab is approved and/or available (in accordance with country-specific regulations), whichever occurs first.

Ravulizumab is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Ultomiris for:
  • Paroxysmal nocturnal hemoglobinuria (PNH)
  • Atypical hemolytic uremic syndrome (aHUS)
🇪🇺
Approved in European Union as Ultomiris for:
  • Paroxysmal nocturnal haemoglobinuria (PNH)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alexion

Lead Sponsor

Trials
247
Recruited
38,600+
Marc Dunoyer profile image

Marc Dunoyer

Alexion

Chief Executive Officer since 2021

PhD in Molecular Biology, University of Brussels

Christophe Hotermans profile image

Christophe Hotermans

Alexion

Chief Medical Officer since 2021

MD, University of Leuven

Alexion Pharmaceuticals, Inc.

Lead Sponsor

Trials
267
Recruited
141,000+
Dr. Alberto R. Martinez profile image

Dr. Alberto R. Martinez

Alexion Pharmaceuticals, Inc.

Chief Medical Officer since 2010

MD from University of Sao Paulo

Marc Dunoyer profile image

Marc Dunoyer

Alexion Pharmaceuticals, Inc.

Chief Executive Officer since 2021

PhD in Molecular Biology

Alexion Pharmaceuticals

Lead Sponsor

Trials
231
Recruited
36,700+
Marc Dunoyer profile image

Marc Dunoyer

Alexion Pharmaceuticals

Chief Executive Officer since 2021

B.A. in Psychology from the University of New Hampshire

Christophe Hotermans profile image

Christophe Hotermans

Alexion Pharmaceuticals

Chief Medical Officer since 2023

MD

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