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Monoclonal Antibodies

Mepolizumab for Hypereosinophilic Syndrome (SPHERE Trial)

Phase 3
Recruiting
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A history of 2 or more HES flares within the past 12 months prior to Screening (Visit 1)
Participant must be aged 6 to 17 years inclusive, at Screening (Visit 1)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 0 to 4 and weeks 48 to 52
Awards & highlights

SPHERE Trial 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.

Who is the study for?
Children and teens aged 6-17 with hypereosinophilic syndrome (HES) for at least 6 months, having a high eosinophil count, stable on current HES therapy, and who've had two or more HES flares in the past year can join. Those with certain infections, cancer history within a year, non-responsive to steroids, prior mepolizumab use or other monoclonal antibodies recently cannot participate.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of mepolizumab when added to standard care for young patients with HES. It aims to see if this treatment helps reduce symptoms and manage the condition better than standard treatments alone.See study design
What are the potential side effects?
Mepolizumab may cause side effects like headache, injection site reactions (pain or swelling), fatigue, back pain. Rarely it might lead to an allergic reaction including rash or breathing difficulties.

SPHERE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had 2 or more episodes of my condition worsening in the last year.
Select...
I am between 6 and 17 years old.

SPHERE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 0 to 4 and weeks 48 to 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 0 to 4 and weeks 48 to 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of HES flares experienced by participants per year
Secondary outcome measures
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
Change in mean daily oral corticosteroids (OCS) dose (prednisone/prednisolone or equivalent) from Weeks 0 to 4 to Weeks 48 to 52
Mepolizumab plasma concentrations
+5 more

Side effects data

From 2016 Phase 3 trial • 136 Patients • NCT02020889
32%
Headache
22%
Arthralgia
21%
Sinusitis
21%
Upper respiratory tract infection
18%
Diarrhoea
18%
Nasopharyngitis
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%
Pruritus
9%
Acute sinusitis
9%
Myalgia
9%
Musculoskeletal pain
9%
Productive cough
9%
Sinus congestion
7%
Wheezing
7%
Alanine aminotransferase increased
7%
Vertigo
7%
Respiratory tract infection
7%
Gastroenteritis
7%
Rhinitis
7%
Abdominal pain upper
7%
Cough
7%
Urinary tract infection
7%
Asthenia
7%
Pain in extremity
6%
Weight increased
6%
Nasal congestion
6%
Fungal skin infection
6%
Oral herpes
6%
Conjunctivitis
6%
Paraesthesia
6%
Urticaria
6%
Vision blurred
6%
Ligament sprain
4%
Aspartate aminotransferase increased
4%
Skin lesion
4%
Muscle spasms
4%
Adrenal insufficiency
4%
Hot flush
4%
Otitis media
4%
Viral infection
4%
Epistaxis
4%
Sneezing
4%
Dizziness
4%
Migraine
4%
Oedema peripheral
4%
Influenza like illness
4%
Cataract
4%
Eye pruritus
4%
Laceration
4%
Contusion
4%
Gamma-glutamyltransferase increased
3%
Insomnia
3%
Abdominal pain
3%
Upper-airway cough syndrome
3%
Injection site pain
3%
Sinus headache
3%
Joint swelling
1%
Ear discomfort
1%
Hernia
1%
Lacunar infarction
1%
Nystagmus
1%
Cerebellar ischaemia
1%
Cardiac arrest
1%
Pachymeningitis
1%
Facial paresis
1%
Dyspepsia
1%
Hypersensitivity
1%
Gastrooesophageal reflux disease
1%
Dyspnoea
1%
Enterococcal infection
1%
Parainfluenzae virus infection
1%
Perirectal abscess
1%
Chest pain
1%
Ear infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Mepolizumab 300mg

SPHERE Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants receiving mepolizumabExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mepolizumab
2020
Completed Phase 3
~4800

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,753 Previous Clinical Trials
8,069,433 Total Patients Enrolled
7 Trials studying Hypereosinophilic Syndrome
504 Patients Enrolled for Hypereosinophilic Syndrome
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,905 Total Patients Enrolled
6 Trials studying Hypereosinophilic Syndrome
494 Patients Enrolled for Hypereosinophilic Syndrome

Media Library

Mepolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04965636 — Phase 3
Hypereosinophilic Syndrome Clinical Trial 2023: Mepolizumab Highlights & Side Effects. Trial Name: NCT04965636 — Phase 3
Mepolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04965636 — Phase 3
Hypereosinophilic Syndrome Research Study Groups: Participants receiving mepolizumab

Frequently Asked Questions

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

How can I sign up for this clinical experiment?

"The ideal candidate for this clinical trial studying leukemia should be 6 to 17 years old, have eosinophilic leukemia, and meet the other inclusion criteria. There are plans to enroll around 25 patients in total."

Answered by AI

Does this research project allow geriatric patients to enroll?

"In order to meet the requirements for this particular clinical trial, applicants must be between 6 and 17 years old. Out of the 1441 total trials, 390 are geared towards pediatric patients while 1051 are meant for adults over 65."

Answered by AI

Is this an innovative way to test a new medication?

"Research into mepolizumab began in 2015 with a trial sponsored by GlaxoSmithKline. This initial study had 104 participants and, after its completion, Mepolizumab received approval for Phase 3 testing. As of now, there are 17 active trials being conducted in 327 cities across 32 countries."

Answered by AI

What other research has been done on Mepolizumab's effects?

"At this moment, there are a total of 17 clinical trials studying Mepolizumab with 9 being in Phase 3. A few of these research projects are situated in Hamilton, Ontario; however, 752 locations worldwide are conducting similar investigations."

Answered by AI

Is this research study looking for more participants?

"That is correct. According to the information available on clinicaltrials.gov, this trial was posted on July 14th, 2020 and is actively recruiting patients. The study plans to enroll 25 individuals at 4 locations."

Answered by AI

How many test subjects are a part of this research project?

"That is correct. At the moment, this study is looking for 25 individuals that meet the requirements specified on clinicaltrials.gov . The posting date was July 14th, 2022 and the most recent edit was on October 7th, 2022. There are 4 different locations where patients can participate in this trial."

Answered by AI

What are the potential risks associated with Mepolizumab?

"Mepolizumab has received a Phase 3 score, which suggests that while there is some efficacy data available, the drug has undergone multiple rounds of testing to confirm its safety."

Answered by AI

Mepolizumab is used to treat which medical conditions?

"Mepolizumab is commonly used to treat hypereosinophilic syndrome (HES), however it can also help patients with conditions like Polyangiitis, who are tapering off of corticosteroid therapy, and those with no identifiable secondary cause."

Answered by AI

Are there a lot of research centers conducting this clinical trial in Canada?

"This clinical trial is currently recruiting patients out of 4 sites. The locations are based in Cleveland, Charleston and Cincinnati as well as 4 other locations. It is helpful to select the site closest you to minimize travel requirements if you enroll."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study in Pediatrics With HypEREosinophilic Syndrome (SPHERE)
2022. "Study in Pediatrics With HypEREosinophilic Syndrome (SPHERE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04965636.
~4 spots leftby Sep 2024
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