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Corticosteroid

Mepolizumab for Churg-Strauss Syndrome

Phase 3
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The treating physician requesting mepolizumab under this LAP considers the benefits of treatment with mepolizumab outweigh the risks for the individual subject.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 89 months
Awards & highlights

Study Summary

This trial is for a potential new treatment for a rare disorder called EGPA, which is characterized by high levels of a certain type of white blood cell. The new treatment, mepolizumab, is given as an injection every 4 weeks and is designed to help regulate the life-cycle of the white blood cells. The trial is designed to see if the treatment is effective and safe.

Eligible Conditions
  • Churg-Strauss Syndrome

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your doctor thinks that the benefits of taking mepolizumab are greater than any potential risks for you.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 89 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 89 months 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 Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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%
Vertigo
7%
Alanine aminotransferase increased
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Subjects from clinical study MEA115921Experimental Treatment2 Interventions
Subjects who participated in clinical study MEA115921 and who require a dose of prednisolone (or equivalent) of 5 mg/day for adequate control of their EGPA will be included. Eligible subjects will receive subcutaneously administered mepolizumab at a dose of 300 mg SC every 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mepolizumab
2020
Completed Phase 3
~4800
Prednisolone
2005
Completed Phase 4
~2720

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,742 Previous Clinical Trials
8,066,261 Total Patients Enrolled
8 Trials studying Churg-Strauss Syndrome
1,386 Patients Enrolled for Churg-Strauss Syndrome
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,593 Previous Clinical Trials
6,143,253 Total Patients Enrolled
4 Trials studying Churg-Strauss Syndrome
716 Patients Enrolled for Churg-Strauss Syndrome

Frequently Asked Questions

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

Mepolizumab is most often associated with which medical condition?

"While ulcerative colitis is the primary condition that mepolizumab is used to treat, this medication can also be used to manage varicella-zoster virus acute retinal necrosis, brain, and inflamed external hemorrhoid."

Answered by AI

Are there numerous research centers administering this trial in Canada?

"Currently, there are 14 active clinical trial sites for this medication, with locations in New york, Cleveland, Saint Louis, and other US cities. If you are selected for the trial, the site administrator will try to place you at the location nearest to you to minimize travel."

Answered by AI

Are there any other scientific experiments that have used Mepolizumab?

"First appearing in 2000 at the Peter MacCallum Cancer Centre, mepolizumab has undergone 256 completed studies. There are currently 107 clinical trials underway, with a significant presence in New york City."

Answered by AI

How many participants will be included in this clinical research?

"At this time, this particular clinical trial is not recruiting any more patients. It was initially posted on April 14th, 2015 but the most recent update was on July 5th, 2022. For those searching for other trials, there are 11 trials recruiting patients with churg-strauss syndrome and 107 trials for Mepolizumab that are still enrolling patients."

Answered by AI

When did the FDA last give their opinion on mepolizumab?

"Mepolizumab is estimated to be a safe medication because it is in Phase 3 clinical trials. In these types of trials, there is data supporting the efficacy of the medication as well as multiple rounds of data supporting safety."

Answered by AI
~10 spots leftby Mar 2025