Mepolizumab for Hypereosinophilic Syndrome

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Hypereosinophilic SyndromeMepolizumab - Drug
Eligibility
6 - 17
All Sexes
What conditions do you have?
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Study Summary

This trial will test if mepolizumab is an effective and safe treatment for children and adolescents with HES who are already receiving standard care therapy.

Eligible Conditions
  • Hypereosinophilic Syndrome

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Weeks 0 to 4 and Weeks 48 to 52

Week 52
Change from Baseline in fatigue severity based on Brief Fatigue Inventory (BFI) Item 3 (worst level of fatigue during past 24 hours) for Week 52
Ratio to Baseline in absolute blood eosinophil count
Up to Week 52
Number of HES flares experienced by participants per year
Number of participants with Anti-drug antibodies (ADA) and neutralizing antibodies (NAb)
Week 52
Mepolizumab plasma concentrations
Week 48
Change in mean daily oral corticosteroids (OCS) dose (prednisone/prednisolone or equivalent) from Weeks 0 to 4 to Weeks 48 to 52
Number of participants with >=50 percent (%) reduction in mean daily OCS dose (prednisone/prednisolone or equivalent) from Weeks 0 to 4 compared with Weeks 48 to 52
Weeks 48 to 52
Prednisolone
Number of participants achieving a mean daily OCS dose (prednisone/prednisolone or equivalent) of <=7.5 milligrams (mg) during Weeks 48 to 52 in participants that are taking OCS at Baseline

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Mepolizumab 300mg
32%Headache
22%Arthralgia
21%Upper respiratory tract infection
21%Sinusitis
18%Nasopharyngitis
18%Diarrhoea
16%Nausea
16%Vomiting
15%Fatigue
15%Asthma
13%Injection site reaction
13%Rash
12%Back pain
12%Oropharyngeal pain
12%Neck pain
10%Influenza
10%Bronchitis
10%Pyrexia
9%Myalgia
9%Acute sinusitis
9%Pruritus
9%Musculoskeletal pain
9%Productive cough
9%Sinus congestion
7%Rhinitis
7%Urinary tract infection
7%Respiratory tract infection
7%Asthenia
7%Cough
7%Gastroenteritis
7%Abdominal pain upper
7%Pain in extremity
7%Wheezing
7%Vertigo
7%Alanine aminotransferase increased
6%Conjunctivitis
6%Urticaria
6%Paraesthesia
6%Nasal congestion
6%Vision blurred
6%Fungal skin infection
6%Oral herpes
6%Ligament sprain
6%Weight increased
4%Influenza like illness
4%Hot flush
4%Oedema peripheral
4%Skin lesion
4%Migraine
4%Adrenal insufficiency
4%Sneezing
4%Epistaxis
4%Dizziness
4%Otitis media
4%Viral infection
4%Muscle spasms
4%Cataract
4%Eye pruritus
4%Laceration
4%Contusion
4%Aspartate aminotransferase increased
4%Gamma-glutamyltransferase increased
3%Insomnia
3%Sinus headache
3%Upper-airway cough syndrome
3%Injection site pain
3%Abdominal pain
3%Joint swelling
1%Cerebellar ischaemia
1%Cardiac arrest
1%Dyspnoea
1%Perirectal abscess
1%Chest pain
1%Enterococcal infection
1%Parainfluenzae virus infection
1%Facial paresis
1%Lacunar infarction
1%Nystagmus
1%Pachymeningitis
1%Hernia
1%Hypersensitivity
1%Ear infection
1%Gastrooesophageal reflux disease
1%Dyspepsia
1%Ear discomfort
This histogram enumerates side effects from a completed 2016 Phase 3 trial (NCT02020889) in the Mepolizumab 300mg ARM group. Side effects include: Headache with 32%, Arthralgia with 22%, Upper respiratory tract infection with 21%, Sinusitis with 21%, Nasopharyngitis with 18%.

Trial Design

1 Treatment Group

Participants receiving mepolizumab
1 of 1

Experimental Treatment

25 Total Participants · 1 Treatment Group

Primary Treatment: Mepolizumab · No Placebo Group · Phase 3

Participants receiving mepolizumab
Drug
Experimental Group · 1 Intervention: Mepolizumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mepolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: weeks 0 to 4 and weeks 48 to 52

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,650 Previous Clinical Trials
7,950,087 Total Patients Enrolled
7 Trials studying Hypereosinophilic Syndrome
504 Patients Enrolled for Hypereosinophilic Syndrome
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,561 Previous Clinical Trials
6,133,503 Total Patients Enrolled
6 Trials studying Hypereosinophilic Syndrome
494 Patients Enrolled for Hypereosinophilic Syndrome

Eligibility Criteria

Age 6 - 17 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are male or female.
You have a history of 2 or more HES flares within the past 12 months prior to Screening (Visit 1).