Ravulizumab for Neuromyelitis Optica Spectrum Disorders

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Clinical Trial Site, Goyang-si, Korea, Republic ofNeuromyelitis Optica Spectrum DisordersRavulizumab - Drug
Eligibility
2 - 17
All Sexes
What conditions do you have?
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Study Summary

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

Eligible Conditions
  • Neuromyelitis Optica Spectrum Disorders

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Eculizumab
1
Ravulizumab
1
Eculizumab

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: Predose and postdose (at end of infusion) on Day 1, Weeks 2, 10, 18, 26, and 42, and predose on Week 50

Baseline through Week 50
Change from Baseline in Free Serum Complement Component 5 (C5) Concentration Over Time Through Week 50
Time to First Adjudicated On-trial Relapse through Week 50
Baseline, Week 50
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
Change From Baseline in Hauser Ambulation Index at Week 50
Change From Baseline in Visual Acuity at Week 50
Change From Baseline in the Annualized Relapse Rate at Week 50
Week 50
Serum Ravulizumab Concentration

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Eculizumab
2
Ravulizumab
2
Eculizumab

Side Effects for

Ravulizumab
27%Headache
22%Nasopharyngitis
19%Upper respiratory tract infection
9%Pyrexia
9%Diarrhoea
8%Nausea
7%Influenza like illness
7%Constipation
6%Fatigue
6%Abdominal pain
6%Vomiting
6%Anaemia
5%Rhinitis
5%Cough
5%Pain in extremity
4%Oropharyngeal pain
3%Chest pain
3%Dizziness
2%Musculoskeletal pain
1%Lower respiratory tract infection
1%Colitis
1%Influenza
1%Respiratory failure
1%Hyperthermia
1%Epilepsy
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT03056040) in the Ravulizumab ARM group. Side effects include: Headache with 27%, Nasopharyngitis with 22%, Upper respiratory tract infection with 19%, Pyrexia with 9%, Diarrhoea with 9%.

Trial Design

1 Treatment Group

Ravulizumab
1 of 1

Experimental Treatment

12 Total Participants · 1 Treatment Group

Primary Treatment: Ravulizumab · No Placebo Group · Phase 2 & 3

Ravulizumab
Drug
Experimental Group · 1 Intervention: Ravulizumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ravulizumab
2021
Completed Phase 4
~310

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: predose and postdose (at end of infusion) on day 1, weeks 2, 10, 18, 26, and 42, and predose on week 50

Who is running the clinical trial?

AlexionLead Sponsor
234 Previous Clinical Trials
39,286 Total Patients Enrolled
4 Trials studying Neuromyelitis Optica Spectrum Disorders
332 Patients Enrolled for Neuromyelitis Optica Spectrum Disorders
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
38,486 Total Patients Enrolled
4 Trials studying Neuromyelitis Optica Spectrum Disorders
332 Patients Enrolled for Neuromyelitis Optica Spectrum Disorders

Eligibility Criteria

Age 2 - 17 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your Expanded Disability Status Scale (EDSS) score needs to be 7 or lower.
References

Frequently Asked Questions

How many test subjects are actively participating in this experiment?

"The clinical trial is enrolling 12 patients between 1 sites." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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