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Monoclonal Antibodies

Ravulizumab for Myasthenia Gravis

Phase 3
Recruiting
Research Sponsored by Alexion
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of Class II to Class IV at Screening
Diagnosis of gMG confirmed by a positive serologic test for anti-AChR antibodies (Abs) obtained at Screening and/or during Screening Period
Must not have
Any untreated thymic malignancy, carcinoma, or thymoma.
History of unexplained infections
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to week 18
Awards & highlights

Summary

This trial studies how well a drug (ravulizumab) works in children with a rare autoimmune disorder (gMG).

Who is the study for?
This trial is for children with generalized Myasthenia Gravis (gMG) who are classified as Class II to IV. They must be on a stable treatment regimen, vaccinated against meningococcal infection, and if previously treated with eculizumab, they should have been on it for at least 6 months. Those with HIV, recent thymic surgery or untreated thymic malignancy cannot participate.
What is being tested?
The study tests Ravulizumab given through an IV in pediatric patients with gMG. It aims to understand how the drug moves and acts within the body (pharmacokinetics/pharmacodynamics), its effectiveness, safety profile, and potential immune response it may cause.
What are the potential side effects?
Potential side effects of Ravulizumab could include reactions at the infusion site, increased risk of infections due to immune system impact, headaches, nausea or vomiting. Specific side effects in children will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My myasthenia gravis is moderate to severe.
Select...
I have been diagnosed with gMG and tested positive for anti-AChR antibodies.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have an untreated cancer in my thymus.
Select...
I have had infections that doctors couldn't explain.
Select...
I am HIV positive.
Select...
I had a benign thymoma that was treated.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to week 18
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to week 18 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change from Baseline in Neurology Quality of Life (Neuro QoL) Pediatric Fatigue Score at Up to Week 18
Change from Baseline in Patient-reported Outcomes Measurement Information System (PROMIS) Parent Proxy - Fatigue Score at Up to Week 18
Number of Participants That Improve or Remain Stable in MG ADL Total Score at Week 18 Compared to Baseline
+1 more

Side effects data

From 2022 Phase 4 trial • 18 Patients • NCT04320602
33%
Fatigue
17%
Cough
17%
Abdominal pain
17%
SARS-CoV-2 test positive
17%
COVID-19
11%
Non-cardiac chest pain
11%
Nasopharyngitis
11%
Back pain
11%
Dyspnoea
6%
Influenza like illness
6%
Pneumonia
6%
Asthenia
6%
Pain
6%
Neurodermatitis
6%
Rash
6%
Retinal haemorrhage
6%
Headache
6%
Peripheral swelling
6%
Herpes zoster
6%
Skin lesion
6%
Chromaturia
6%
Haemoglobinuria
6%
Nephrolithiasis
6%
Pyrexia
6%
Upper respiratory tract infection
6%
Urinary tract infection
6%
Body temperature abnormal
6%
Nail ridging
6%
Constipation
6%
Arthralgia
6%
Pain in extremity
6%
Extravascular haemolysis
6%
Chest discomfort
6%
Oropharyngeal pain
6%
Upper respiratory tract congestion
6%
Haemoglobin decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ravulizumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ravulizumab Intravenous (IV) InfusionExperimental Treatment1 Intervention
All participants will receive a weight-based loading dose of ravulizumab IV on Day 1, followed by weight-based maintenance dose of ravulizumab on Day 15 and once every 8 weeks (q8w) thereafter for participants weighing ≥ 20 kg, or once every 4 weeks (q4w) for participants weighing \< 20 kg, for a total of 122 weeks of treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ravulizumab
2016
Completed Phase 4
~1090

Find a Location

Who is running the clinical trial?

AlexionLead Sponsor
246 Previous Clinical Trials
39,258 Total Patients Enrolled
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
37,344 Total Patients Enrolled
Alexion Pharmaceuticals, Inc.Lead Sponsor
257 Previous Clinical Trials
41,053 Total Patients Enrolled
~7 spots leftby Jul 2026
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