Open-Label Extension Study of Reslizumab in Pediatric Subjects With Eosinophilic Esophagitis

Eosinophilic Esophagitis Clinical Trial

Official title:

An Open-Label Safety and Efficacy Study of Reslizumab (CTx55700) for the Treatment of Pediatric Subjects With Eosinophilic Esophagitis Who Completed Study Res-5-0002

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00635089
• Other study ID #: Res-5-0004
• Status: Completed
• Phase: Phase 3
• First received: March 6, 2008
• Last updated: August 16, 2013
• Start date: May 2008
• Est. completion date: January 2012

Study information

• Verified date: August 2013
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is an open-label study where all subjects will receive active drug, reslizumab. Subjects are able to enter this trial only through completion of study Res-5-0002.

The goal of the study is to show longer term safety and efficacy in pediatric subjects who have eosinophilic esophagitis.

Description:

Subjects will enter this open-label extension study after completing the placebo-controlled, double-blind study Res-5-0002. The end of study visit for Res-5-0002 will serve as the screening visit for this trial.

All subjects will receive reslizumab and be followed by their principal investigators in an unblinded fashion. Visits and administration of reslizumab will be monthly.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

• Informed consent

• Received at least two doses of study drug in Study 5-0002

• Did not withdraw from Study 5-0002 due to drug related AE

• Completed End of Treatment Visit for Study 5-0002

Exclusion Criteria:

• Pregnant or nursing females

• Concurrent Immunodeficiency

• Current use of immunosuppressive drugs

• Did not tolerate study drug in Study 5-0002

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

Drug:
• reslizumab
initial dosing of reslizumab 1mg/kg i.v.monthly

Locations

Country	Name	City	State
Canada	Pediatric Allergy and Immunology	Edmonton	Alberta
Canada	University of Montreal	Montreal	Quebec
United States	Children's Center for Digestive Health Care	Atlanta	Georgia
United States	Denver Childrens At Aurora, Colorado	Aurora	Colorado
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	The Children's Hospital of Alabama	Birmingham	Alabama
United States	Tuft's Floating Hospital	Boston	Massachusetts
United States	1st Allergy and Clinical Research Center	Centennial	Colorado
United States	Children'S Memorial Hospital Division of Gastroenterology Hepatology & Nutrition	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	Cincinnati Children's	Cincinnati	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	University of Texas Southwest Medical Center	Dallas	Texas
United States	Pediatric Allergy and Immunology of Duke Medical Center	Durham	North Carolina
United States	Greenville Health System	Greenville	South Carolina
United States	Kaiser Permanente Hospital- Pediatric Gastroenterology	Hayward	California
United States	Riley Hospital for Children	Indianapolis	Indiana
United States	Las Vegas Pediatric Gastroenterology Associates	Las Vegas	Nevada
United States	Arkansas Children's Hospital/University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	South Jersey Pediatric Gastroenterology	Mays Landing	New Jersey
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Mount Sinai School of Medicine, Pediatrics	New York	New York
United States	Creighton University Medical Center	Omaha	Nebraska
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 Philadelphia	Philadelphia	Pennsylvania
United States	Minnesota Gastroenterology	Plymouth	Minnesota
United States	Children's Pavilion	Richmond	Virginia
United States	Carilion Medical Center for Children	Roanoke	Virginia
United States	University of Utah School of Medicine	Salt Lake City	Utah
United States	Children's Hospital of San Diego	San Diego	California
United States	Saint Louis University	St. Louis	Missouri
United States	State University of New York (SUNY)	Syracuse	New York
United States	University of Arizona Dept. of Pediatrics	Tucson	Arizona
United States	Center for Digestive Allergic and Immunologic Diseases	Williamsville	New York
United States	Thomas Jefferson University Medical College	Wilmington	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Ception Therapeutics	Cephalon

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety profile of reslizumab		approximately 4 months	No
Secondary	profile of durability of response to treatment		approximately 4 months	No