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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Eosinophilic Esophagitis

In brief

This trial will study three doses of reslizumab versus placebo in children with eosinophilic esophagitis (EE). The objectives of the trial will be to study the effectiveness of reslizumab in improving the clinical signs and symptoms and reducing esophageal eosinophils as well as assessing the safety profile compared to placebo.

Key facts

Study ID

NCT00538434

Run by

Ception Therapeutics

People needed

227

Starts

2008-03-01

Expected to finish

2009-10-01

Last updated by the study team

2016-09-02

Who can join

Age: 5 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 specific barrier methods outlined in the protocol
• confirmed active EE (at Screening or within six weeks prior to Baseline Visit) as defined by esophageal mucosal eosinophils greater than or equal to 24 per high power field (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 movement upward), abdominal, chest pain/heartburn (burning or pain behind the sternum), or difficulty swallowing
• been on a therapeutic dose of proton pump inhibitors (PPIs; with or without histamine H2 receptor antagonists)for at least four weeks without resolution of symptoms, or by negative pH probe (with or without having failed a course of PPIs)

You may not qualify if…

• another disorder that causes esophageal eosinophilia (e.g., hypereosinophilic syndrome [HES],Churg Strauss vasculitis, eosinophilic gastroenteritis [EG], or a parasitic infection)
• 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 for intestinal atresia
• use of systemic immunosuppressive or immunomodulating agents (anti-immunoglobulin E [IgE] monoclinal antibody [mAb], methotrexate, cyclosporin, interferon alpha [α], or anti 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 prior to study entry
• use of swallowed inhaled corticosteroids for the treatment of EE within one month prior to study entry. Note: Inhaled and nasal corticosteroids for the treatment of asthma and allergies, respectively, are permitted provided that the dose remains the same 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 to study entry
• female subjects who are pregnant or nursing
• concurrent infection or disease that may preclude assessment of EE
• concurrent immunodeficiency (human immunodeficiency [HIV], or acquired immunodeficiency syndrome [AIDS] or congenital immunodeficiency)

Where it is running

• The Children's Hospital of Alabama — Birmingham, Alabama, United States
• University of Arizona Dept. of Pediatrics — Tucson, Arizona, United States
• Arkansas Children's Hospital/University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Kaiser Permanente Hospital- Pediatric Gastroenterology — Hayward, California, United States
• Children'S Hospital of Orange County Pediatric Subspecialty Faculty Division of Allergy and Asthma — Orange, California, United States
• Pediatric Allergy/Immunology — Palo Alto, California, United States
• Children's Hospital of San Diego — San Diego, California, United States
• Denver Childrens At Aurora, Colorado — Aurora, Colorado, United States
• 1st Allergy and Clinical Research Center — Centennial, Colorado, United States
• Thomas Jefferson University Medical College — Wilmington, Delaware, United States
• Children's Center for Digestive Health Care — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Children'S Memorial Hospital Division of Gastroenterology Hepatology & Nutrition — Chicago, Illinois, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Sinai Hospital of Baltimore — Baltimore, Maryland, United States
• Tuft's Floating Hospital — Boston, Massachusetts, United States
• Minnesota Gastroenterology — Plymouth, Minnesota, United States
• Saint Louis University — St Louis, Missouri, United States
• Creighton University Medical Center — Omaha, Nebraska, United States
• Las Vegas Pediatric Gastroenterology Associates — Las Vegas, Nevada, United States
• South Jersey Pediatric Gastroenterology — Mays Landing, New Jersey, United States
• Mount Sinai School of Medicine, Pediatrics — New York, New York, United States
• State University of New York (SUNY) — Syracuse, New York, United States
• Center for Digestive Allergic and Immunologic Diseases — Williamsville, New York, United States
• Pediatric Allergy and Immunology of Duke Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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