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Monoclonal Antibodies

Ravulizumab for Neuromyelitis Optica Spectrum Disorders

Phase 3
Waitlist Available
Research Sponsored by Alexion
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body weight ≥40 kilograms
At least 1 attack or relapse in the last 12 months prior to the Screening Period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 2.25 years (end of the primary treatment period)
Awards & highlights

Study Summary

This trial will test how well ravulizumab works in treating NMOSD in adults.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects of Ravulizumab may include headache, nausea, infections like the common cold or urinary tract infections. More serious risks could involve trouble with the body’s immune response or infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I weigh at least 40 kilograms.
Select...
I have had at least one relapse in the past year.
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I am positive for anti-aquaporin-4 antibody and have been diagnosed with NMOSD.
Select...
My disability score is 7 or less.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 2.25 years (end of the primary treatment period)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 2.25 years (end of the primary treatment period) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With an Adjudicated On-trial Relapse in the Primary Treatment Period
Secondary outcome measures
Adjudicated On-trial Annualized Relapse Rate (ARR) in the Primary Treatment Period
Change From Baseline in EQ-5D Visual Analog Scale (VAS) Score at the End of Primary Treatment Period
Change From Baseline in European Quality of Life Health 5-dimension Questionnaire (EQ-5D) Index Score at the End of Primary Treatment Period
+6 more

Side effects data

From 2022 Phase 3 trial • 195 Patients • NCT03056040
31%
Headache
30%
Nasopharyngitis
28%
Upper respiratory tract infection
21%
Fatigue
19%
Diarrhoea
19%
Pyrexia
18%
Nausea
17%
Cough
15%
Abdominal pain
14%
Back pain
14%
Dizziness
13%
Pain in extremity
11%
Arthralgia
11%
Influenza like illness
10%
Oropharyngeal pain
10%
Rhinitis
8%
Vomiting
8%
Abdominal pain upper
8%
Dyspnoea
8%
Urinary tract infection
8%
Anaemia
7%
Constipation
6%
Chest pain
6%
Dysphagia
5%
Gastroenteritis
5%
Pruritus
5%
Myalgia
5%
Palpitations
5%
Influenza
3%
Haemolysis
2%
Lower respiratory tract infection
2%
Haemolytic anaemia
1%
Hyperthermia
1%
Cholelithiasis
1%
Foot deformity
1%
Basal cell carcinoma
1%
Colitis
1%
Bone marrow failure
1%
Infection
1%
Pneumonia
1%
Post procedural infection
1%
Liver disorder
1%
Depression
1%
Epilepsy
1%
Respiratory failure
1%
Enteritis
1%
Pneumoperitoneum
1%
Toothache
1%
Bile duct stone
1%
Biliary colic
1%
Cholecystitis
1%
COVID-19
1%
Bacteraemia
1%
Escherichia sepsis
1%
Escherichia urinary tract infection
1%
Pneumonia bacterial
1%
Postoperative wound infection
1%
Rhinovirus infection
1%
Septic shock
1%
Ankle fracture
1%
Ligament injury
1%
Transfusion reaction
1%
Cerebrospinal fluid retention
1%
Loss of consciousness
1%
Dupuytren's contracture
1%
Intervertebral disc degeneration
1%
Osteonecrosis
1%
Ureterolithiasis
1%
Urinary retention
1%
Major depression
1%
Suicide attempt
1%
Dermal cyst
1%
Invasive papillary breast carcinoma
1%
Aplastic anaemia
1%
Breakthrough haemolysis
1%
Tibia fracture
1%
Lower limb fracture
1%
Deep vein thrombosis
1%
Endometrial cancer
1%
Lung cancer metastatic
1%
Renal cancer metastatic
1%
Seborrhoeic keratosis
1%
Pharyngitis
1%
Pneumococcal infection
1%
Liver function test increased
1%
Road traffic accident
1%
Suspected COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ravulizumab
Eculizumab

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ravulizumab
2021
Completed Phase 4
~1080

Find a Location

Who is running the clinical trial?

AlexionLead Sponsor
246 Previous Clinical Trials
39,219 Total Patients Enrolled
5 Trials studying Neuromyelitis Optica Spectrum Disorders
408 Patients Enrolled for Neuromyelitis Optica Spectrum Disorders
Alexion Pharmaceuticals, Inc.Lead Sponsor
253 Previous Clinical Trials
41,124 Total Patients Enrolled
6 Trials studying Neuromyelitis Optica Spectrum Disorders
438 Patients Enrolled for Neuromyelitis Optica Spectrum Disorders
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
37,365 Total Patients Enrolled
4 Trials studying Neuromyelitis Optica Spectrum Disorders
286 Patients Enrolled for Neuromyelitis Optica Spectrum Disorders

Media Library

Ravulizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04201262 — Phase 3
Neuromyelitis Optica Spectrum Disorders Research Study Groups: Ravulizumab
Neuromyelitis Optica Spectrum Disorders Clinical Trial 2023: Ravulizumab Highlights & Side Effects. Trial Name: NCT04201262 — Phase 3
Ravulizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04201262 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there long-term repercussions to using Ravulizumab?

"There is already some evidence that ravulizumab is effective, and it has been tested multiple times for safety, so it received a score of 3."

Answered by AI

Are recruitment efforts for this research still underway?

"The research indicates that this study is no longer actively recruiting patients. Although the trial originally started on December 13th, 2019, the most recent update was on June 23rd, 2022. It's worth noting that there are 40 other trials currently underway that participants can sign up for."

Answered by AI

What medical conditions does Ravulizumab usually help alleviate?

"Ravulizumab is a medication that is most often given to patients when their disease is active. However, it can also help those suffering from hemolysis, thrombotic microangiopathies, and atypical hemolytic uremic syndrome."

Answered by AI

How many people can be enrolled in this experiment at one time?

"This particular clinical trial is no longer recruiting patients. The study was originally posted on December 13th, 2019 but the most recent update was on June 23rd, 2022. For those still looking for trials to participate in, there are 24 active studies for neuromyelitis optica and 16 for Ravulizumab that are currently enrolling patients."

Answered by AI

Is this research the first time this topic has been explored?

"To date, there have been 16 completed and live clinical trials for Ravulizumab in 31 countries and 193 cities. The first trial was sponsored by Alexion Pharmaceuticals in 2016 and involved 270 patients. It completed its Phase 3 drug approval stage that year. In the 5 years since then, 5 more trials have been conducted."

Answered by AI

Is this trial readily available in many urban locations?

"To date, 23 clinical sites have been recruited to participate in this trial. If you are interested in enrolling, please consider selecting a location nearest to you from the list of Mobile, Dallas, Houston and other locations. This will help minimize travel time and related demands."

Answered by AI

What other research has been published on Ravulizumab?

"Since 2016, ravulizumab has undergone 5 clinical trials at the original research site. Today, there are 16 active studies underway with a large portion of them based in Mobile, Alabama."

Answered by AI

Who else is applying?

What state do they live in?
Texas
New York
How old are they?
18 - 65
What site did they apply to?
Clinical Study Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD
2019. "An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04201262.
~11 spots leftby Apr 2025
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