Intravenous Mepolizumab In Children With Eosinophilic Esophagitis
This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous mepolizumab in pediatric subjects with eosinophilic esophagitis.
Official Title
A Randomized, Double-Blind, Parallel Group Clinical Trial to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Mepolizumab (SB240563)(0.55mg/kg, 2.5mg/kg or 10mg/kg) in Pediatric Subjects With Eosinophilic Esophagitis, Aged 2 to 17 Years (Study MEE103219)
Conditions
Eosinophilic Esophagitis
Study Type
Interventional
Study Design
Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study
Further Details
Primary Outcome Measures:
- Safety and tolerability at Week 12 Pharmacokinetic parameters Proportion of subjects who achieve a reduction in peak eosinophils at Week 12 [Time Frame: 12 Weeks]
Secondary Outcome Measures:
- Relationship between dose and clinical response assessed by change from baseline and the average during Weeks 9-12 and 20-24 Time to relapse in responders Relationship between PD (pharmacodynamics) and PK(pharmacokinetics). [Time Frame: 24 Weeks]
Study Start
August 2006
Eligibility & Criteria
- Ages Eligible for Study: 2 Years – 17 Years
- Genders Eligible for Study: Both
Inclusion criteria:
- Isolated eosinophil esophagitis defined as greater than/equal to 20 eosinophils/HPF.
Exclusion criteria:
- Current evidence of EGID (Eosinophilic Gastrointestinal Enteropathy) other than eosinophilic esophagitis.
- Active H. pylori.
- Current or suspected evidence of GERD (Gastroesophageal Reflux Disease) or other causes of esophagitis.
- Current evidence or history of celiac disease, esophageal or generalized eosinophilia associated with infiltration in the esophagus (HES, allergic gastroenteritis, bacterial infection, parasitic infestations, collagen vascular disease, vasculitis, allergic drug reaction, graft-versus host disease).
Total Enrolment
72
Contact Details
- Parkville, Victoria, 3052, Australia
- Murdoch, Western Australia, 6150, Australia
Contact GlaxoSmithKline Australia (Please refer to this study by ClinicalTrials.gov identifier NCT00358449)
Dates
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