Clinical trial NCT00538434: Efficacy and Safety Study of Reslizumab to Treat Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years
Official title: An Efficacy and Safety Study of Reslizumab (CTx55700) in the Treatment of Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Eosinophilic Esophagitis
Keywords: Eosinophilic Esophagitis
GERD
EE
Reslizumab
IL-5
Interleukin-5
Cinquil
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2007-10-02
Enrollment: 227
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Mean Percent Change From Baseline to End of Treatment in Peak Esophageal Eosinophil (EE) Levels
timeFrame: Baseline, End of Treatment (up to 15 weeks [+/- 4 days])
measure: Mean Change From Baseline in Physician's Esophageal Eosinophil (EE) Global Assessment At The End-of-Treatment Visit (or at Early Withdrawal)
timeFrame: Baseline (Day 1, pre-treatment), End of Treatment (Week 15, 3 weeks [± 4 days] after the last dose of study drug, or at early withdrawal)
Secondary outcomes:
measure: Mean Change From Baseline to End of Treatment in EE Predominant Symptom Assessment
timeFrame: Baseline (Day 1, pre-treatment), End of Treatment (Week 15, 3 weeks [± 4 days] after the last dose of study drug, or at early withdrawal)
measure: Mean Percent Change From Baseline to End of Treatment in the Child Health Questionnaire (CHQ)
timeFrame: Baseline, End of Treatment (up to 15 weeks +/- 4 days)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The Children's Hospital of Alabama
state: Alabama
city: Tucson
country: United States
facility: University of Arizona Dept. of Pediatrics
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Children's Hospital/University of Arkansas for Medical Sciences
state: Arkansas
city: Hayward
country: United States
facility: Kaiser Permanente Hospital- Pediatric Gastroenterology
state: California
city: Orange
country: United States
facility: Children'S Hospital of Orange County Pediatric Subspecialty Faculty Division of Allergy and Asthma
state: California
city: Palo Alto
country: United States
facility: Pediatric Allergy/Immunology
state: California
city: San Diego
country: United States
facility: Children's Hospital of San Diego
state: California
city: Aurora
country: United States
facility: Denver Childrens At Aurora, Colorado
state: Colorado
city: Centennial
country: United States
facility: 1st Allergy and Clinical Research Center
state: Colorado
city: Wilmington
country: United States
facility: Thomas Jefferson University Medical College
state: Delaware
city: Atlanta
country: United States
facility: Children's Center for Digestive Health Care
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Chicago
country: United States
facility: Children'S Memorial Hospital Division of Gastroenterology Hepatology & Nutrition
state: Illinois
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Boston
country: United States
facility: Tuft's Floating Hospital
state: Massachusetts
city: Plymouth
country: United States
facility: Minnesota Gastroenterology
state: Minnesota
city: St. Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: Las Vegas Pediatric Gastroenterology Associates
state: Nevada
city: Mays Landing
country: United States
facility: South Jersey Pediatric Gastroenterology
state: New Jersey
city: New York
country: United States
facility: Mount Sinai School of Medicine, Pediatrics
state: New York
city: Syracuse
country: United States
facility: State University of New York (SUNY)
state: New York
city: Williamsville
country: United States
facility: Center for Digestive Allergic and Immunologic Diseases
state: New York
city: Durham
country: United States
facility: Pediatric Allergy and Immunology of Duke Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
city: Dallas
country: United States
facility: University of Texas Southwest Medical Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Roanoke
country: United States
facility: Carilion Medical Center for Children
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Edmonton
country: Canada
facility: Pediatric Allergy and Immunology
state: Alberta
city: Edmonton
country: Canada
facility: Pediatric Allergy & Immunology
state: Alberta
city: Montreal
country: Canada
facility: University of Montreal
state: Quebec
Study officials:
affiliation: Cephalon (Ception)
name: Sponsor's Medical Expert, MD
role: STUDY_DIRECTOR
References:
citation: 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.