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Monoclonal Antibodies

Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis

Phase 3
Waitlist Available
Research Sponsored by Alexion Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 26
Awards & highlights
Pivotal Trial

Summary

This trial will test if ravulizumab is safe and effective for treating generalized myasthenia gravis.

Eligible Conditions
  • Myasthenia Gravis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 26
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 26 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline In Myasthenia Gravis-Activities Of Daily Living (MG-ADL) Total Score At Week 26
Secondary study objectives
Change From Baseline In The Quantitative Myasthenia Gravis (QMG) Total Score At Week 26
Myasthenia Gravis
Change From Baseline in Neurological Quality of Life (Neuro-QoL) Fatigue Score at Week 26
+2 more

Side effects data

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RavulizumabExperimental Treatment1 Intervention
Participants will receive ravulizumab for the duration of the study.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo during the 26-week randomized-controlled period of the study, after which they will enter the open-label extension period of the study and receive ravulizumab.
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?

Alexion Pharmaceuticals, Inc.Lead Sponsor
263 Previous Clinical Trials
140,416 Total Patients Enrolled
11 Trials studying Myasthenia Gravis
1,191 Patients Enrolled for Myasthenia Gravis
AlexionLead Sponsor
246 Previous Clinical Trials
38,343 Total Patients Enrolled
9 Trials studying Myasthenia Gravis
1,104 Patients Enrolled for Myasthenia Gravis
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
36,429 Total Patients Enrolled
9 Trials studying Myasthenia Gravis
1,104 Patients Enrolled for Myasthenia Gravis
~26 spots leftby Jan 2026
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