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

Sponsored by:	Ception Therapeutics
Information provided by:	Ception Therapeutics
ClinicalTrials.gov Identifier:	NCT00635089

Purpose

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.

Condition	Intervention	Phase
Eosinophilic Esophagitis	Drug: reslizumab	Phase III

Drug Information available for: Reslizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Ception Therapeutics:

Primary Outcome Measures:

Safety profile of reslizumab [ Time Frame: approximately 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

profile of durability of response to treatment [ Time Frame: approximately 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	212
Study Start Date:	May 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Open-Label Open-label active cohort	Drug: reslizumab initial dosing of reslizumab 1mg/kg i.v.monthly

Detailed 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.

Eligibility

Ages Eligible for Study:	5 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635089

Show 36 Study Locations

Sponsors and Collaborators

Ception Therapeutics

Investigators

Study Director:

H Jeffrey Wilkins, MD

Ception Therapeutics

More Information

No publications provided

Responsible Party:	Ception Therapeutics ( H. Jeffrey Wilkins, MD )
Study ID Numbers:	Res-5-0004
Study First Received:	March 6, 2008
Last Updated:	May 1, 2009
ClinicalTrials.gov Identifier:	NCT00635089 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ception Therapeutics:

Eosinophilic Esophagitis
Cinquil

Study placed in the following topic categories:

Esophagitis
Digestive System Diseases
Esophageal Disorder
Gastrointestinal Diseases

Esophageal Diseases
Gastroenteritis
Eosinophilic Enteropathy

Additional relevant MeSH terms:

Esophagitis
Digestive System Diseases
Gastrointestinal Diseases
Esophageal Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on May 07, 2009