Efficacy and Safety Study of Reslizumab to Treat Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years

Inclusion Criteria:

• written informed consent obtained

• male or female patients aged 5 to 18 years at time of screening

• of non-childbearing potential, of childbearing potential and willing to use specificbarrier methods outlined in the protocol

• confirmed active EE (at Screening or within six weeks prior to Baseline Visit) asdefined by esophageal mucosal eosinophils greater than or equal to 24 per high powerfield (hpf; 400X magnification)

• within the week prior to dosing, patient has one of the following symptoms of moderate (or worse) severity: vomiting, regurgitation (acid taste or feeling material movementupward), abdominal, chest pain/heartburn (burning or pain behind the sternum), ordifficulty swallowing

• been on a therapeutic dose of proton pump inhibitors (PPIs; with or without histamineH2 receptor antagonists)for at least four weeks without resolution of symptoms, or bynegative pH probe (with or without having failed a course of PPIs)

Exclusion Criteria:

• another disorder that causes esophageal eosinophilia (e.g., hypereosinophilic syndrome [HES],Churg Strauss vasculitis, eosinophilic gastroenteritis [EG], or a parasiticinfection)

• history of abnormal gastric or duodenal biopsy or documented gastrointestinal [GI]disorders (e.g., celiac disease, Crohn's disease or Helicobacter pylori infection)

• history of the following GI surgeries: fundoplication, gastric surgery or surgery forintestinal atresia

• use of systemic immunosuppressive or immunomodulating agents (anti-immunoglobulin E [IgE] monoclinal antibody [mAb], methotrexate, cyclosporin, interferon alpha [α], oranti tumor necrosis factor [TNF] mAb) within six months prior to study entry

• received attenuated live attenuated vaccines (e.g., measles, mumps, rubella [MMR],bacillus Calmette-Guerin [BCG], varicella, FluMist or polio) within three months priorto study entry

• use of swallowed inhaled corticosteroids for the treatment of EE within one monthprior to study entry. Note: Inhaled and nasal corticosteroids for the treatment ofasthma and allergies, respectively, are permitted provided that the dose remains thesame during the study

• a stricture on endoscopy that prevents passage of the endoscope

• participation in any investigational drug or device study within 30 days prior tostudy entry

• female subjects who are pregnant or nursing

• concurrent infection or disease that may preclude assessment of EE

• concurrent immunodeficiency (human immunodeficiency [HIV], or acquiredimmunodeficiency syndrome [AIDS] or congenital immunodeficiency)