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

Eosinophilic Esophagitis Clinical Trial

Official title:

An Efficacy and Safety Study of Reslizumab (CTx55700) in the Treatment of Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00538434
• Other study ID #: Res-05-0002
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 1, 2007
• Last updated: August 16, 2013
• Start date: February 2008
• Est. completion date: October 2009

Study information

• Verified date: August 2013
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Ethics Review CommitteeUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

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 eosinophilic esophagitis (at Screening or within six weeks prior to Baseline Visit) as defined by esophageal mucosal eosinophils greater than or equal to 24 per 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 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.,HES,Churg Strauss vasculitis, EG, or a parasitic infection)

• history of abnormal gastric or duodenal biopsy or documented 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] mAb, methotrexate, cyclosporin, interferon a, 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], Bacille 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 eosinophilic esophagitis.

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

Biological:
• Reslizumab
IV (in the vein) on Day 0 of each 28 days cycle (+/-7 days) Number of Cycles=4

Other:
• Saline
IV (in the vein) on Day 0 of each 28 days cycle (+/-7 days) Number of Cycles=4)

Locations

Country	Name	City	State
Canada	Pediatric Allergy & Immunology	Edmonton	Alberta
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	Virginia Commonwealth University	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 (1)

Lead Sponsor	Collaborator
Ception Therapeutics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	esophageal eosinophil counts (co-primary)		15 weeks	No
Primary	EE Global Assessment (co-primary)		15 weeks	No
Secondary	EE Predominant Symptom Assessment		15 weeks	No
Secondary	Child Health Questionnaire		15 weeks	No