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

NCT ID: NCT00538434

Last Updated: 2016-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 227 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-10-31

Brief Summary

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.

Conditions

Eosinophilic Esophagitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Reslizumab 1 mg/kg

reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles

Group Type: EXPERIMENTAL

Reslizumab

Intervention Type: BIOLOGICAL

Reslizumab 2 mg/kg

reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles

Group Type: EXPERIMENTAL

Reslizumab

Intervention Type: BIOLOGICAL

Reslizumab 3 mg/kg

reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles

Group Type: EXPERIMENTAL

Reslizumab

Intervention Type: BIOLOGICAL

Placebo

saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: OTHER

Interventions

Reslizumab

Intervention Type: BIOLOGICAL

Saline

Intervention Type: OTHER

Other Intervention Names

CTx55700; Cinquil™; CEP-38072

Eligibility Criteria

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 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)

Exclusion Criteria

• 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)

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ception Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sponsor's Medical Expert, MD

Role: STUDY_DIRECTOR

Cephalon (Ception)

Locations

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

Cincinnati Children's

Cincinnati, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Greenville Health System

Greenville, South Carolina, United States

University of Texas Southwest Medical Center

Dallas, Texas, United States

University of Utah School of Medicine

Salt Lake City, Utah, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Carilion Medical Center for Children

Roanoke, Virginia, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Pediatric Allergy and Immunology

Edmonton, Alberta, Canada

Pediatric Allergy & Immunology

Edmonton, Alberta, Canada

University of Montreal

Montreal, Quebec, Canada

Countries

United States; Canada

References

Spergel JM, Rothenberg ME, Collins MH, Furuta GT, Markowitz JE, Fuchs G 3rd, O'Gorman MA, Abonia JP, Young J, Henkel T, Wilkins HJ, Liacouras CA. Reslizumab in children and adolescents with eosinophilic esophagitis: results of a double-blind, randomized, placebo-controlled trial. J Allergy Clin Immunol. 2012 Feb;129(2):456-63, 463.e1-3. doi: 10.1016/j.jaci.2011.11.044. Epub 2011 Dec 28.

Reference Type: RESULT

PMID: 22206777 (View on PubMed)

Other Identifiers

Res-05-0002

Identifier Type: -

Identifier Source: org_study_id