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Monoclonal Antibodies

Ravulizumab for 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
Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at screening.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 26
Awards & highlights

Study Summary

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

Eligible Conditions
  • Myasthenia Gravis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have moderate to severe Myasthenia Gravis, as determined by a medical evaluation.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline In Myasthenia Gravis-Activities Of Daily Living (MG-ADL) Total Score At Week 26
Secondary outcome measures
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 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%
Dizziness
14%
Back pain
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%
Cholelithiasis
1%
Colitis
1%
Bone marrow failure
1%
Hyperthermia
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%
Foot deformity
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%
Basal cell 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

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
2021
Completed Phase 4
~1080

Find a Location

Who is running the clinical trial?

Alexion Pharmaceuticals, Inc.Lead Sponsor
252 Previous Clinical Trials
41,077 Total Patients Enrolled
10 Trials studying Myasthenia Gravis
1,403 Patients Enrolled for Myasthenia Gravis
AlexionLead Sponsor
246 Previous Clinical Trials
39,202 Total Patients Enrolled
9 Trials studying Myasthenia Gravis
1,103 Patients Enrolled for Myasthenia Gravis
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
37,348 Total Patients Enrolled
9 Trials studying Myasthenia Gravis
1,103 Patients Enrolled for Myasthenia Gravis

Frequently Asked Questions

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

When did the FDA give ravulizumab their official seal of approval?

"There is existing evidence that Ravulizumab is safe as well as effective, so it received a score of 3."

Answered by AI

Are researchers looking for more participants at this moment?

"The clinical trial in question is not seeking patients at the moment, as evidenced by an inactive status on clinicaltrials.gov. This particular study was created on March 26th, 2019 and updated for the last time on May 3rd, 2022. There are a total of 103 other trials that are currently looking for participants."

Answered by AI

Does this medical research have any precedents?

"As of now, there are 16 ongoing studies for Ravulizumab in 31 countries and 193 cities. The first clinical trial for the drug was sponsored by Alexion Pharmaceuticals in 2016 and completed its Phase 3 approval stage that same year. Since then, 18283 more trials have been conducted."

Answered by AI

What conditions does Ravulizumab help ameliorate?

"Ravulizumab is frequently used to manage disease activity, but it can also help patients with hemolysis, thrombotic microangiopathies, and atypical hemolytic uremic syndrome."

Answered by AI

What other similar medical experiments have there been with Ravulizumab?

"Currently, there are 16 active clinical trials for Ravulizumab with 13 being in Phase 3. Most of these studies taking place in Whittier, California; however, 842 locations across the globe are conducting similar research."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
~29 spots leftby Mar 2025