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Monoclonal Antibodies

Anti-IL5 (Mepolizumab) for Eosinophilic Esophagitis

Phase 1 & 2
Waitlist Available
Led By Marc E. Rothenberg, MD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
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 up to 5 years
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved

Summary

Toxicity of anti-IL-5

Eligible Conditions
  • Eosinophilic Esophagitis
  • Eosinophilic Granulomatosis with Polyangiitis
  • Hypereosinophilic Syndrome
  • Eosinophilic Gastroenteritis
  • Churg-Strauss Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2016 Phase 3 trial • 136 Patients • NCT02020889
32%
Headache
22%
Arthralgia
21%
Sinusitis
21%
Upper respiratory tract infection
18%
Nasopharyngitis
18%
Diarrhoea
16%
Vomiting
16%
Nausea
15%
Asthma
15%
Fatigue
13%
Rash
13%
Injection site reaction
12%
Back pain
12%
Neck pain
12%
Oropharyngeal pain
10%
Influenza
10%
Bronchitis
10%
Pyrexia
9%
Myalgia
9%
Musculoskeletal pain
9%
Productive cough
9%
Acute sinusitis
9%
Sinus congestion
9%
Pruritus
7%
Respiratory tract infection
7%
Vertigo
7%
Wheezing
7%
Gastroenteritis
7%
Pain in extremity
7%
Asthenia
7%
Cough
7%
Abdominal pain upper
7%
Alanine aminotransferase increased
7%
Urinary tract infection
7%
Rhinitis
6%
Fungal skin infection
6%
Oral herpes
6%
Paraesthesia
6%
Conjunctivitis
6%
Nasal congestion
6%
Urticaria
6%
Vision blurred
6%
Weight increased
6%
Ligament sprain
4%
Epistaxis
4%
Gamma-glutamyltransferase increased
4%
Oedema peripheral
4%
Sneezing
4%
Cataract
4%
Viral infection
4%
Laceration
4%
Influenza like illness
4%
Dizziness
4%
Migraine
4%
Skin lesion
4%
Eye pruritus
4%
Aspartate aminotransferase increased
4%
Muscle spasms
4%
Contusion
4%
Otitis media
4%
Adrenal insufficiency
4%
Hot flush
3%
Upper-airway cough syndrome
3%
Joint swelling
3%
Abdominal pain
3%
Sinus headache
3%
Insomnia
3%
Injection site pain
1%
Cardiac arrest
1%
Nystagmus
1%
Gastrooesophageal reflux disease
1%
Enterococcal infection
1%
Ear infection
1%
Chest pain
1%
Lacunar infarction
1%
Cerebellar ischaemia
1%
Dyspnoea
1%
Ear discomfort
1%
Hernia
1%
Pachymeningitis
1%
Perirectal abscess
1%
Facial paresis
1%
Hypersensitivity
1%
Dyspepsia
1%
Parainfluenzae virus infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mepolizumab 300mg
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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

1Treatment groups
Experimental Treatment
Group I: Anti-IL5 (Mepolizumab)Experimental Treatment1 Intervention
The purpose of the study is to assess the toxicity of anti-IL-5 (Mepolizumab), and to see whether it lowers eosinophils in peripheral blood and/or tissue and whether it has a steroid and/or interferon sparing effect.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mepolizumab
FDA approved

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
835 Previous Clinical Trials
6,565,143 Total Patients Enrolled
16 Trials studying Eosinophilic Esophagitis
7,783 Patients Enrolled for Eosinophilic Esophagitis
Marc E. Rothenberg, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
~1 spots leftby Nov 2025