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Monoclonal Antibodies

Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia Gravis

Phase 2
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
All Individual Drugs Already Approved

Summary

The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of patients with generalized myasthenia gravis despite treatment with various immunosuppressants, such as prednisone, methotrexate, Cellcept, cyclosporine, and cyclophosphamide, that are currently available.

Eligible Conditions
  • Myasthenia Gravis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Quantitative Myasthenia Gravis (QMG): The Primary Efficacy Endpoint in This Study Was the Percentage of Patients With a 3-point Reduction From Baseline in the QMG Total Score for Disease Severity.
Secondary study objectives
Change From Baseline in Respiratory Function Tests to Characterize the Degree of Involvement of Respiratory Muscles.
Change From Baseline in the MG-Activity of Daily Living Profile (MG-ADL)
Change From Baseline in the MGFA Post-Intervention Status (PIS)
+4 more

Side effects data

From 2021 Phase 3 trial • 119 Patients • NCT02003144
22%
Upper respiratory tract infection
19%
Headache
19%
Arthralgia
17%
Nasopharyngitis
17%
Urinary tract infection
15%
Pyrexia
14%
Back pain
13%
Influenza
9%
Fatigue
9%
Pain in extremity
8%
Anaemia
8%
Diarrhoea
8%
Constipation
6%
Iron deficiency anaemia
6%
Muscle spasms
6%
Dizziness
6%
Oropharyngeal pain
6%
Hypoaesthesia
6%
Cough
6%
Cystitis
6%
Musculoskeletal pain
5%
Periodontitis
5%
Oedema peripheral
5%
Dental caries
5%
Contusion
5%
Rash
5%
Muscular weakness
5%
Oral herpes
5%
Bronchitis
5%
Rhinorrhoea
4%
Neuromyelitis optica spectrum disorder
4%
Insomnia
4%
Paraesthesia
4%
Nausea
4%
Thermal burn
3%
Pyelonephritis acute
3%
Optic neuritis
3%
Intervertebral disc protrusion
3%
Dyspepsia
3%
Peripheral swelling
3%
Asthma
3%
Urosepsis
3%
Herpes zoster
1%
Ventricular fibrillation
1%
Device related infection
1%
Abscess limb
1%
Glaucoma
1%
Infective tenosynovitis
1%
Staphylococcal bacteraemia
1%
Cholecystitis acute
1%
Respiratory tract infection
1%
Muscle spasticity
1%
COVID-19 pneumonia
1%
COVID-19
1%
Femoral neck fracture
1%
Escherichia pyelonephritis
1%
Pneumonia bacterial
1%
Pyelonephritis
1%
Streptococcal infection
1%
Wrist fracture
1%
Hypophosphataemia
1%
Clavicle fracture
1%
Spondylolisthesis
1%
Pulmonary embolism
1%
Neuromuscular blockade
1%
Neuromyelitis optica pseudo relapse
1%
Anembryonic gestation
1%
Urinary retention
1%
Endometriosis
1%
Bronchiectasis
1%
Venous thrombosis limb
1%
Pharyngitis
1%
Toothache
1%
Urinary incontinence
1%
Pneumonia
1%
Gastroenteritis
1%
Psoas abscess
1%
Head injury
1%
Spinal compression fracture
1%
Sinusitis
1%
Osteonecrosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Eculizumab/Eculizumab
Eculizumab (Combined Total)
Placebo/Eculizumab

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 1Experimental Treatment1 Intervention
eculizumab
Group II: 2Placebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eculizumab
FDA approved

Find a Location

Who is running the clinical trial?

Alexion Pharmaceuticals, Inc.Lead Sponsor
263 Previous Clinical Trials
140,577 Total Patients Enrolled
11 Trials studying Myasthenia Gravis
1,352 Patients Enrolled for Myasthenia Gravis
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
36,590 Total Patients Enrolled
9 Trials studying Myasthenia Gravis
1,265 Patients Enrolled for Myasthenia Gravis
AlexionLead Sponsor
246 Previous Clinical Trials
38,504 Total Patients Enrolled
9 Trials studying Myasthenia Gravis
1,265 Patients Enrolled for Myasthenia Gravis
~1 spots leftby Dec 2025
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