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New drug shows promise in rare nerve disease trial

NCT ID NCT04201262

Disease control Sponsor: Alexion Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested the drug ravulizumab (Ultomiris) in 58 adults with neuromyelitis optica spectrum disorder (NMOSD), a rare condition where the immune system attacks the optic nerves and spinal cord. The goal was to see if the drug could prevent relapses. Participants received intravenous infusions every 8 weeks. The study is complete, and results will show whether ravulizumab reduces relapse rates compared to an external placebo group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ravulizumab (Ultomiris)
What this could lead to
If successful, this could provide a new treatment option to reduce relapses in people with NMOSD, a rare autoimmune disease that attacks the nervous system.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The study used an external placebo comparison, which may be less reliable than a randomized controlled design. Risks include infusion reactions and increased infection risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

58 people

The number who actually took part.

Started

Dec 2019

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Anti-aquaporin-4 antibody-positive and a diagnosis of NMOSD as defined by the 2015 international consensus diagnostic criteria. 2. At least 1 attack or relapse in the last 12 months prior to the Screening Period. 3. Expanded Disability Status Scale score ≤7. 4. Participants who enter the study receiving supportive immunosuppressive therapy must be on a stable dosing regimen of adequate duration prior to Screening. 5. Body weight ≥40 kilograms. 6. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Exclusion Criteria: 1. History of Neisseria meningitidis infection. 2. Human immunodeficiency virus (HIV) infection (evidenced by HIV-1 or HIV-2 antibody titer). 3. Previously or currently treated with a complement inhibitor. 4. Use of rituximab or mitoxantrone within 3 months prior to Screening. 5. Use of IV immunoglobulin within 3 weeks prior to Screening.

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Conditions

The condition(s) this trial relates to.

acute transverse myelitis demyelinating disease neuromyelitis optica optic neuritis Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neuromyelitis optica Neuromyelitis optica spectrum disorder

Contacts and locations

Locations

  • Research Site

    Aurora, Colorado, 80045, United States

  • Research Site

    Fort Collins, Colorado, 80528, United States

  • Research Site

    Washington D.C., District of Columbia, 20007, United States

  • Research Site

    Miami, Florida, 33136, United States

  • Research Site

    Boston, Massachusetts, 02114, United States

  • Research Site

    Rochester, Minnesota, 55905, United States

  • Research Site

    Jackson, Mississippi, 39216, United States

  • Research Site

    St Louis, Missouri, 63110, United States

  • Research Site

    Cincinnati, Ohio, 45219, United States

  • Research Site

    Houston, Texas, 77030, United States

  • Research Site

    Camperdown, 2050, Australia

  • Research Site

    Fitzroy, 3065, Australia

  • Research Site

    Vienna, 1090, Austria

  • Research Site

    Burnaby, British Columbia, V5G 2X6, Canada

  • Research Site

    Aarhus, 8200, Denmark

  • Research Site

    Strasbourg, 67098, France

  • Research Site

    Berlin, 10117, Germany

  • Research Site

    Leipzig, 04103, Germany

  • Research Site

    München, 81675, Germany

  • Research Site

    Cefalù, 90015, Italy

  • Research Site

    Gallarate, 21013, Italy

  • Research Site

    Naples, 80131, Italy

  • Research Site

    Roma, 00133, Italy

  • Research Site

    Rome, 00178, Italy

  • Research Site

    Chiba, 260-0877, Japan

  • Research Site

    Fukuoka, 812-8582, Japan

  • Research Site

    Kawagoe-shi, 350-8550, Japan

  • Research Site

    Niigata, 951-8585, Japan

  • Research Site

    Sendai, 980-8574, Japan

  • Research Site

    Sendai, 983-8512, Japan

  • Research Site

    Katowice, 40-571, Poland

  • Research Site

    Lódz, 90-324, Poland

  • Research Site

    Goyang-si, 10408, South Korea

  • Research Site

    Seoul, 02841, South Korea

  • Research Site

    Seoul, 03722, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Seoul, 143-729, South Korea

  • Research Site

    Barcelona, 08036, Spain

  • Research Site

    Madrid, 28040, Spain

  • Research Site

    Málaga, 29010, Spain

  • Research Site

    Oxford, OX3 9DU, United Kingdom

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