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Monoclonal Antibodies

Ravulizumab for Myasthenia Gravis

Q: Are applications still being accepted for this experiment?

According to clinicaltrials.gov, this research project is actively recruiting patients, with the initial posting occuring on June 9th 2023 and a recent update from October 9th 2023.

Q: Is there an age-based restriction to participation in this medical research?

This clinical trial is only open to applicants aged 6-18. Specifically, 12 studies are targeted towards minors and 71 studies focus on people over the retirement age of 65.

Q: What potential adverse effects might be associated with Ravulizumab Intravenous (IV) Infusion?

On a scale of 1-3, our team evaluates ravulizumab intravenous infusion to have a safety rating of 3. This is due to evidence from Phase 3 trials indicating efficacy and multiple rounds demonstrating its security.

Q: How many participants are being invited to join this clinical study?

Affirmative. The details listed on clinicaltrials.gov declare that this research endeavour, first posted on June 9th 2023, is actively recruiting patients for participation. As of now there are 12 sought after volunteers enrolling from 2 different sites.

Q: How might I become eligible to participate in this experiment?

Analyzing this <a href="https://www.withpower.com/clinical-trials/experimental">experimental</a> procedure, 12 participants between the ages of 6 and 18 with guillain-barré syndrome must be enrolled. Additionally, these patients must have a positive serologic test for anti-AChR antibodies (Abs), classified as MGFA Clinical Classification II to IV at Screening, been on a stable dosing regimen prior to screening and during the screening period., experienced eculizumab treatment in Study ECU-MG-303 for six months minimum with two months on a stable dose before enrollment; and most importantly <a href="https://www.withpower.com/clinical-trials/all">all</a> candidates should receive meningococcal vaccination.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to week 126 (8 weeks after last dose of study drug)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to week 126 (8 weeks after last dose of study drug)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to week 126 (8 weeks after last dose of study drug)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to week 126 (8 weeks after last dose of study drug) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Plasma Concentration of Ravulizumab

Serum Free C5 Concentration of Ravulizumab

Secondary outcome measures

Change From Baseline in Myasthenia Gravis Composite (MGC) Score at Up to Week 18

Change From Baseline in Myasthenia Gravis-Activities Of Daily Living (MG-ADL) Total Score at Up to Week 18

Change From Baseline in The Quantitative Myasthenia Gravis (QMG) Total Score at Up to Week 18

+9 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

Vomiting

Abdominal pain upper

Dyspnoea

Urinary tract infection

Anaemia

Constipation

Chest pain

Dysphagia

Gastroenteritis

Pruritus

Myalgia

Palpitations

Influenza

Haemolysis

Lower respiratory tract infection

Haemolytic anaemia

Basal cell carcinoma

Hyperthermia

Cholelithiasis

Foot deformity

Colitis

Bone marrow failure

Infection

Pneumonia

Post procedural infection

Liver disorder

Depression

Epilepsy

Respiratory failure

Enteritis

Pneumoperitoneum

Toothache

Bile duct stone

Biliary colic

Cholecystitis

COVID-19

Bacteraemia

Escherichia sepsis

Escherichia urinary tract infection

Pneumonia bacterial

Postoperative wound infection

Rhinovirus infection

Septic shock

Ankle fracture

Ligament injury

Transfusion reaction

Cerebrospinal fluid retention

Loss of consciousness

Dupuytren's contracture

Intervertebral disc degeneration

Osteonecrosis

Ureterolithiasis

Urinary retention

Major depression

Suicide attempt

Dermal cyst

Invasive papillary breast carcinoma

Aplastic anaemia

Breakthrough haemolysis

Tibia fracture

Lower limb fracture

Deep vein thrombosis

Endometrial cancer

Lung cancer metastatic

Renal cancer metastatic

Seborrhoeic keratosis

Pharyngitis

Pneumococcal infection

Liver function test increased

Road traffic accident

Suspected COVID-19

100%

80%

60%

40%

20%

Study treatment Arm

Ravulizumab

Eculizumab

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

2021

Completed Phase 4

~1080

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

AlexionLead Sponsor

246 Previous Clinical Trials

39,265 Total Patients Enrolled

Alexion PharmaceuticalsLead Sponsor

230 Previous Clinical Trials

37,411 Total Patients Enrolled

Alexion Pharmaceuticals, Inc.Lead Sponsor

253 Previous Clinical Trials

41,190 Total Patients Enrolled

Frequently Asked Questions

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

Are applications still being accepted for this experiment?

"According to clinicaltrials.gov, this research project is actively recruiting patients, with the initial posting occuring on June 9th 2023 and a recent update from October 9th 2023."

Answered by AI

Is there an age-based restriction to participation in this medical research?

"This clinical trial is only open to applicants aged 6-18. Specifically, 12 studies are targeted towards minors and 71 studies focus on people over the retirement age of 65."

Answered by AI

What potential adverse effects might be associated with Ravulizumab Intravenous (IV) Infusion?

"On a scale of 1-3, our team evaluates ravulizumab intravenous infusion to have a safety rating of 3. This is due to evidence from Phase 3 trials indicating efficacy and multiple rounds demonstrating its security."

Answered by AI

How many participants are being invited to join this clinical study?

"Affirmative. The details listed on clinicaltrials.gov declare that this research endeavour, first posted on June 9th 2023, is actively recruiting patients for participation. As of now there are 12 sought after volunteers enrolling from 2 different sites."

Answered by AI

How might I become eligible to participate in this experiment?

"Analyzing this experimental procedure, 12 participants between the ages of 6 and 18 with guillain-barré syndrome must be enrolled. Additionally, these patients must have a positive serologic test for anti-AChR antibodies (Abs), classified as MGFA Clinical Classification II to IV at Screening, been on a stable dosing regimen prior to screening and during the screening period., experienced eculizumab treatment in Study ECU-MG-303 for six months minimum with two months on a stable dose before enrollment; and most importantly all candidates should receive meningococcal vaccination."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of Pharmacokinetics, Pharmacodynamics, Efficacy, Safety, and Immunogenicity of Ravulizumab Administered Intravenously in Pediatric Participants With Generalized Myasthenia Gravis (gMG)

2023. "Evaluation of Pharmacokinetics, Pharmacodynamics, Efficacy, Safety, and Immunogenicity of Ravulizumab Administered Intravenously in Pediatric Participants With Generalized Myasthenia Gravis (gMG)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05644561.

All > Myasthenia Gravis