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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
Must not have
Use of rituximab within 6 months prior to Day 1
Use of intravenous immunoglobulin (IVIg) or plasma exchange (PE) within 3 weeks prior to Screening
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

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.
Select...
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.
Select...
I am positive for anti-AQP4 antibodies and have been diagnosed with NMOSD.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not used rituximab in the last 6 months.
Select...
I haven't had IVIg or plasma exchange in the last 3 weeks.

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%
Bone marrow failure
1%
Hyperthermia
1%
Foot deformity
1%
Cholelithiasis
1%
Colitis
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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Ravulizumab, a treatment for Neuromyelitis Optica Spectrum Disorders (NMOSD), works by inhibiting complement protein C5, thereby reducing inflammation and preventing damage to the central nervous system. This mechanism is crucial for NMOSD patients as it helps to mitigate the autoimmune attack on the optic nerves and spinal cord, which are characteristic of the disorder. Other treatments, such as eculizumab, also target the complement system to achieve similar protective effects. By reducing the inflammatory response, these treatments aim to prevent relapses and long-term disability, significantly improving the quality of life for NMOSD patients.

Find a Location

Who is running the clinical trial?

Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
37,409 Total Patients Enrolled
4 Trials studying Neuromyelitis Optica Spectrum Disorders
325 Patients Enrolled for Neuromyelitis Optica Spectrum Disorders
Alexion Pharmaceuticals, Inc.Lead Sponsor
255 Previous Clinical Trials
41,279 Total Patients Enrolled
6 Trials studying Neuromyelitis Optica Spectrum Disorders
477 Patients Enrolled for Neuromyelitis Optica Spectrum Disorders
AlexionLead Sponsor
246 Previous Clinical Trials
39,313 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
~5 spots leftby Mar 2026
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