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Monoclonal Antibodies

Ravulizumab for Neuromyelitis Optica Spectrum Disorders

Phase 2 & 3
Recruiting
Research Sponsored by Alexion Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Complement inhibitor treatment-naïve participants must have had at least 1 attack or relapse in the last 12 months prior to the Screening Period
All participants must be vaccinated against meningococcal infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose and postdose (at end of infusion) on day 1, weeks 2, 10, 18, 26, and 42, and predose on week 50
Awards & highlights

Study Summary

This trialstudies a drug to help children with a rare disorder affecting the brain and spinal cord.

Who is the study for?
This trial is for pediatric patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) who are positive for anti-AQP4 antibodies. They should have an EDSS score ≤ 7 and be stable on current treatments, including eculizumab if applicable. Participants must be vaccinated against meningococcal infections and other specific diseases, and not have used certain immune therapies or participated in conflicting studies recently.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of a medication called Ravulizumab in children with NMOSD. It aims to see how well this drug works in preventing relapses of the disease compared to previous treatments they may have received.See study design
What are the potential side effects?
While specific side effects for Ravulizumab in this trial aren't listed, similar drugs can cause reactions like headache, nausea, potential risk of infection due to immune system suppression, infusion-related reactions, and rarely meningitis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had at least one attack or relapse of my condition in the past year and have not received complement inhibitor treatment.
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I am vaccinated against meningococcal infection.
Select...
My disability score is 7 or less.
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I have been stable on eculizumab for 30 days and took it for at least 90 days without missing doses in the last 2 months.
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I am positive for anti-AQP4 antibodies and have been diagnosed with NMOSD.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose and postdose (at end of infusion) on day 1, weeks 2, 10, 18, 26, and 42, and predose on week 50
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose and postdose (at end of infusion) on day 1, weeks 2, 10, 18, 26, and 42, and predose on week 50 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in the Annualized Relapse Rate at Week 50
Time to First Adjudicated On-trial Relapse through Week 50
Secondary outcome measures
Change From Baseline in Color Vision at Week 50
Change From Baseline in Confrontational Visual Fields at Week 50
Change From Baseline in Expanded Disability Status Scale Score At Week 50
+4 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%
Basal cell carcinoma
1%
Hyperthermia
1%
Cholelithiasis
1%
Foot deformity
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 weight-based dosing of ravulizumab IV for a total of 50 weeks of treatment. During the Extension Period, participants will continue to receive weight-based dosing of ravulizumab IV for up to 104 weeks.
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?

Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
37,407 Total Patients Enrolled
4 Trials studying Neuromyelitis Optica Spectrum Disorders
325 Patients Enrolled for Neuromyelitis Optica Spectrum Disorders
Alexion Pharmaceuticals, Inc.Lead Sponsor
254 Previous Clinical Trials
41,221 Total Patients Enrolled
6 Trials studying Neuromyelitis Optica Spectrum Disorders
477 Patients Enrolled for Neuromyelitis Optica Spectrum Disorders
AlexionLead Sponsor
246 Previous Clinical Trials
39,261 Total Patients Enrolled
5 Trials studying Neuromyelitis Optica Spectrum Disorders
447 Patients Enrolled for Neuromyelitis Optica Spectrum Disorders

Media Library

Ravulizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05346354 — Phase 2 & 3
Neuromyelitis Optica Spectrum Disorders Research Study Groups: Ravulizumab
Neuromyelitis Optica Spectrum Disorders Clinical Trial 2023: Ravulizumab Highlights & Side Effects. Trial Name: NCT05346354 — Phase 2 & 3
Ravulizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05346354 — Phase 2 & 3

Frequently Asked Questions

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

How many test subjects are actively participating in this experiment?

"The clinical trial is enrolling 12 patients between 1 sites."

Answered by AI

How can I get involved in this research project?

"This clinical trial is admitting 12 participants, within the ages of 2 and 17 who have neuromyelitis optica. It is important that patients also meet the following criteria: Participants must be anti-AQP4 Ab-positive and have a diagnosis of NMOSD as defined by the 2015 international consensus diagnostic criteria., Complement inhibitor treatment-naïve participants must have had at least 1 attack or relapse in the last 12 months prior to the Screening Period., Expanded Disability Status Scale (EDSS) score ≤ 7., Eculizumab-experienced participants must be clinically stable per Investigator for 30 days and have been"

Answered by AI

Are we still looking for participants in this research?

"The study is currently ongoing and actively recruiting patients, as reflected in the clinicaltrials.gov posting from June 23rd, 2022 to November 4th, 2022."

Answered by AI

Does this clinical trial have an age limit? If so, what is it?

"This particular study is only enrolling patients aged 2-17, however there are 6 other trials for pediatric patients and 16 clinical trials for elderly patients."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I've tried other treatments but unfortunately nothing works.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety Study of Ravulizumab IV in Pediatric Participants With NMOSD
2022. "Efficacy and Safety Study of Ravulizumab IV in Pediatric Participants With NMOSD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05346354.
~6 spots leftby Mar 2026
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