Clinical trial NCT00635089: Open-Label Extension Study of Reslizumab in Pediatric Subjects With Eosinophilic Esophagitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Eosinophilic Esophagitis
Keywords: Eosinophilic Esophagitis
Cinquil
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Cephalon
First posted: 2008-03-13
Enrollment: 190
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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-05-0002 (NCT00538434).

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

Detailed description: Subjects will enter this open-label extension study after completing the placebo-controlled, double-blind study Res-5-0002 (NCT00538434). The end of study visit for Res-05-0002 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 criteria: Inclusion Criteria:

* Informed consent
* Received at least two doses of study drug in Study Res-05-0002 (NCT00538434)
* Did not withdraw from Study Res-05-0002 due to drug related adverse event
* Completed End of Treatment Visit for Study Res-05-0002

Exclusion Criteria:

* Pregnant or nursing females
* Concurrent Immunodeficiency
* Current use of immunosuppressive drugs
* Did not tolerate study drug in Study Res-05-0002

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, or Discontinuation Due to AEs
timeFrame: From start of study drug until end of treatment (mean [standard deviation {SD}] duration of treatment was 30.0 [5.89] months)
measure: Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Hematology Value
timeFrame: From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)
measure: Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Serum Chemistry Laboratory Test Results or Urinalysis Abnormality
timeFrame: From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)
measure: Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Vital Signs Value
timeFrame: From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)
measure: Number of Participants With Newly Diagnosed Physical Examination Abnormalities at Endpoint
timeFrame: From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)
measure: Infusion Site Evaluations
timeFrame: Day 0, Weeks 4, 8, 12, 16, endpoint (last visit), any time during study (mean [SD] duration of treatment was 30.0 [5.89] months)
measure: Therapeutic Classification of Concomitant Medications in at Least 10% of Participants
timeFrame: From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)
Secondary outcomes:
measure: Mean Change From Baseline to Endpoint in Peak Esophageal Eosinophil Counts
timeFrame: Baseline, Week 16 or early withdrawal (if before Week 16)
measure: Participant's EoE Predominant Symptoms Over Time
timeFrame: Every 3 weeks from Day 0 up to Week 42 (mean [SD] duration of treatment was 30.0 [5.89] months)
measure: Physician's EoE Global Assessment Over Time
timeFrame: Every 3 weeks from Day 0 up to Week 42 (mean [SD] duration of treatment was 30.0 [5.89] months)
measure: Mean Change From Baseline to Endpoint in Selected Child Health Questionnaire (CHQ) Scores
timeFrame: Baseline through Endpoint (last visit; mean [SD] duration of treatment was 30.0 [5.89] months)
measure: Dietary Question Responses at Endpoint
timeFrame: Study endpoint (mean [SD] duration of treatment was 30.0 [5.89] months)
measure: Reslizumab Serum Concentrations
timeFrame: Before treatment (within 3 hours) and after treatment (within 3 hours after end of infusion) for doses at Weeks 8 and 12; within 6 days after either dose at Weeks 8 or 12; 2 to 4 weeks after dose at Weeks 8 or 12; and at premature withdrawal.
measure: Number of Participants With >/= 1 Confirmed Positive Value for Anti-drug Antibodies (ADA)
timeFrame: From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)
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: Children's Pavilion
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: Montreal
country: Canada
facility: University of Montreal
state: Quebec
Study officials:
affiliation: Cephalon
name: Sponsor's Medical Expert, MD
role: STUDY_DIRECTOR
References: