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.

[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[studytype]Interventional[studydesign]Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study [studydetails]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]

[studystart]August 2006[eligibility]

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).

[enrolment]72[contact]