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

Primary Purpose

Eosinophilic Esophagitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
reslizumab
Sponsored by
Ception Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eosinophilic Esophagitis focused on measuring Eosinophilic Esophagitis, Cinquil

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Children's Hospital of Alabama
  • University of Arizona Dept. of Pediatrics
  • Arkansas Children's Hospital/University of Arkansas for Medical Sciences
  • Kaiser Permanente Hospital- Pediatric Gastroenterology
  • Children'S Hospital of Orange County Pediatric Subspecialty Faculty Division of Allergy and Asthma
  • Pediatric Allergy/Immunology
  • Children's Hospital of San Diego
  • Denver Childrens At Aurora, Colorado
  • 1st Allergy and Clinical Research Center
  • Thomas Jefferson University Medical College
  • Children's Center for Digestive Health Care
  • University of Chicago
  • Children'S Memorial Hospital Division of Gastroenterology Hepatology & Nutrition
  • Riley Hospital for Children
  • Sinai Hospital of Baltimore
  • Tuft's Floating Hospital
  • Minnesota Gastroenterology
  • Saint Louis University
  • Creighton University Medical Center
  • Las Vegas Pediatric Gastroenterology Associates
  • South Jersey Pediatric Gastroenterology
  • Mount Sinai School of Medicine, Pediatrics
  • State University of New York (SUNY)
  • Center for Digestive Allergic and Immunologic Diseases
  • Pediatric Allergy and Immunology of Duke Medical Center
  • Cincinnati Children's
  • Nationwide Children's Hospital
  • Children's Hospital of Philadelphia
  • Greenville Health System
  • University of Texas Southwest Medical Center
  • University of Utah School of Medicine
  • Children's Pavilion
  • Carilion Medical Center for Children
  • Medical College of Wisconsin
  • Pediatric Allergy and Immunology
  • University of Montreal

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Open-Label Reslizumab

Arm Description

Open-label reslizumab intravenous (IV) infusion at an initial dose of 1 mg/kg monthly

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, or Discontinuation Due to AEs
An AE was defined as any adverse experience, including side effect, injury, toxicity, sensitivity reaction, intercurrent illness, or sudden death, whether or not it was considered related to the use of study drug. Treatment emergent adverse events were those that started any time after the administration of the first dose of study drug (at baseline of this study) and before the cessation of study drug. Serious adverse events that occurred any time after the administration of the first dose of study drug until 30 days after administration of the last dose of study drug were reported as treatment emergent serious adverse events.
Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Hematology Value
Hematology laboratory tests performed include: hemoglobin, hematocrit, red blood cell count, mean cell volume, mean cell hemoglobin, mean cell hemoglobin concentration, platelet count, white blood cell count, and differential count and percentage (polymorphonuclear leukocytes [neutrophils], lymphocytes, eosinophils, monocytes, basophils, platelets).
Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Serum Chemistry Laboratory Test Results or Urinalysis Abnormality
Serum chemistry laboratory tests performed include: calcium, phosphorus, magnesium, sodium, potassium, chloride, creatinine, glucose [nonfasting], blood urea nitrogen, total cholesterol, uric acid, alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, gamma glutamyl transpeptidase, alkaline phosphatase, bicarbonate, creatine kinase, total protein, albumin, total bilirubin, direct bilirubin, indirect bilirubin. Urinalysis tests performed include: protein, glucose, ketones, bilirubin, urobilinogen, nitrite content, pH, specific gravity, white blood cells, microscopic (red blood cells, white blood cells, casts, crystals).
Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Vital Signs Value
Low systolic blood pressure: < 90 and decrease (↓) of 30 mm Hg from baseline (BL) (ages 5-18); high systolic blood pressure: > 160 and increase (↑) of 30 mm Hg from BL (age 5-12), > 130 and ↑ of 30 mm Hg from BL (age 13-18). Low diastolic blood pressure: < 45 and ↓ of 12 mm Hg from BL (age 5-12), < 55 and ↓ of 12 mm Hg from BL (age 13-18), < 50 and ↓ of 15 mm Hg from BL; high diastolic blood pressure: > 85 and ↑ of 12 mm Hg from BL (ages 5-18). Low heart rate: < 80 and and ↓ of 30 beats per minute (bpm) from BL (age 5-12), < 60 and and ↓ of 30 bpm from BL (age 13-18), < 50 and and ↓ of 15 bpm from BL (age > 18); high heart rate: > 120 and ↑ of 30 bpm from BL (age 5-12), > 100 and ↑ of 30 bpm from BL (age 13-18), > 100 and ↑ of 15 bpm from BL (age > 18). Low oral body temperature: < 35.8° Celsius (age 5 to >18); high oral body temperature: > 38.1° C and ↑ 2° Celsius from BL (age 5-18).
Number of Participants With Newly Diagnosed Physical Examination Abnormalities at Endpoint
HEENT=head, eyes, ears, nose and throat.
Infusion Site Evaluations
The infusion site was assessed before treatment and within 30 minutes after the end of the infusion at each monthly treatment visit (or at early withdrawal if before Week 16). The infusion site was graded according to a 5-point scale as follows: 0=no tenderness at IV site, no erythema, no swelling, no induration, no purulence, no palpable venous cord; 1=tender IV site, no erythema, no swelling, no induration, no purulence, no palpable venous cord; 2=tender IV site with erythema, some degree of swelling, no induration, no purulence, no palpable venous cord; 3=tender IV site with erythema and swelling, with induration or palpable venous cord, no purulence; 4=frank vein thrombosis, along with all signs of grade 3 with purulence; IV may stop running because of thrombosis. After the 16-week visit, formal infusion site evaluations were not continued. However, any infusion site reactions were recorded as adverse events and graded as other adverse events.
Therapeutic Classification of Concomitant Medications in at Least 10% of Participants
Number of participants receiving therapeutic classes of concomitant medications.

Secondary Outcome Measures

Mean Change From Baseline to Endpoint in Peak Esophageal Eosinophil Counts
The mean change from baseline in esophageal eosinophil levels was described at week 16 or early withdrawal (if before week 16), using descriptive statistics. Baseline was defined as the last assessment before the first dose of reslizumab, which was the baseline of the double-blind study (NCT00538434) for patients who received reslizumab in the double blind study or the baseline of the open-label study for patients who received placebo during the double-blind study.
Participant's EoE Predominant Symptoms Over Time
The data from the patient's/parent's eosinophilic esophagitis (EoE) Symptom Assessment were used to assess the shift from baseline in Predominant Symptom Assessment. The predominant symptom of the participant's/parent's EoE Symptom Assessment was selected at the double-blind baseline visit and remained the same throughout this study. Using the EoE Symptom Assessment, the participant/parent or legal guardian rated the severity of the previous week's EoE symptoms as none, mild, moderate, severe, or very severe on a 5-point scale. Only the predominant symptom selected for each participant contributed to the overall analysis of the Predominant Symptom Assessment and the subgroup analyses of individual symptoms. Thus, for the Predominant Symptom Analysis, some patients had dysphagia assessed, while others had either abdominal/chest pain or vomiting/regurgitation assessed.
Physician's EoE Global Assessment Over Time
The data from the participant's/parent's EoE Symptom Assessment, in combination with other observations, were used by physicians to determine the Physician's EoE Global Assessment. All components of the patient's EoE Symptom Assessment were used by physicians to determine the Physician's EoE Global Assessment.
Mean Change From Baseline to Endpoint in Selected Child Health Questionnaire (CHQ) Scores
The Child Health Questionnaire comprises 50 items. Specific items are recoded and/or recalibrated. Raw scores for scales (domains calculated over one or more items) are then calculated following set algorithms. The raw scales are then transformed to 0 to 100 scores, except for Change in Health which remains a 1-5 score. Finally two summary measures are calculated based on weighted combinations of selected scales. The Global Health, Physical Summary Score and Psychosocial Summary Score were summarized. For each, scores range from 0 (higher disease activity) to 100 (lower disease activity); higher scores indicate better health.
Dietary Question Responses at Endpoint
Number of participants answering that they either maintained or changed their diet from the beginning of the double-blind study (ie, NCT00538434). Additionally, for those participants who answered that they changed their diet from the beginning of the double-blind study (column 2), the number of participants in that group who changed by increasing the consistency of their food ('Increased consistency') and the percentage that changed by eating foods that previously worsened EoE ('Added foods'). (Note that these 2 categories are not mutually exclusive, so that someone could have both increased the consistency of the food they were eating AND also eaten foods that previously worsened their EoE symptoms.)
Reslizumab Serum Concentrations
Reslizumab serum concentrations obtained in this study were included in ongoing and separate population pharmacokinetic analyses. The Number of Participants Analyzed reflects the number of participants who had concentrations measured following that dose level. Since some participants started on 1 mg/kg and later increased to 2 mg/kg (and are therefore represented in more than one column), the number of participants in each column add up to a greater number than the total in the overall column, which reflects the total number of participants with measurable concentration data in this study. The number of concentrations summarized for that dose level represents more than one concentration per participant in most cases.
Number of Participants With >/= 1 Confirmed Positive Value for Anti-drug Antibodies (ADA)
Using a validated enzyme-linked immunosorbent assay (ELISA), the number of participants who had at least 1 confirmed positive value for ADA, either on day 0 after having received reslizumab in the double-blind study Res-05-0002 (NCT00538434) or during the course of the open-label study.

Full Information

First Posted
March 6, 2008
Last Updated
February 2, 2017
Sponsor
Ception Therapeutics
Collaborators
Cephalon
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1. Study Identification

Unique Protocol Identification Number
NCT00635089
Brief Title
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

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ception Therapeutics
Collaborators
Cephalon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis
Keywords
Eosinophilic Esophagitis, Cinquil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open-Label Reslizumab
Arm Type
Other
Arm Description
Open-label reslizumab intravenous (IV) infusion at an initial dose of 1 mg/kg monthly
Intervention Type
Drug
Intervention Name(s)
reslizumab
Other Intervention Name(s)
Cinquil™, CEP-38072, CTx55700
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, or Discontinuation Due to AEs
Description
An AE was defined as any adverse experience, including side effect, injury, toxicity, sensitivity reaction, intercurrent illness, or sudden death, whether or not it was considered related to the use of study drug. Treatment emergent adverse events were those that started any time after the administration of the first dose of study drug (at baseline of this study) and before the cessation of study drug. Serious adverse events that occurred any time after the administration of the first dose of study drug until 30 days after administration of the last dose of study drug were reported as treatment emergent serious adverse events.
Time Frame
From start of study drug until end of treatment (mean [standard deviation {SD}] duration of treatment was 30.0 [5.89] months)
Title
Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Hematology Value
Description
Hematology laboratory tests performed include: hemoglobin, hematocrit, red blood cell count, mean cell volume, mean cell hemoglobin, mean cell hemoglobin concentration, platelet count, white blood cell count, and differential count and percentage (polymorphonuclear leukocytes [neutrophils], lymphocytes, eosinophils, monocytes, basophils, platelets).
Time Frame
From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)
Title
Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Serum Chemistry Laboratory Test Results or Urinalysis Abnormality
Description
Serum chemistry laboratory tests performed include: calcium, phosphorus, magnesium, sodium, potassium, chloride, creatinine, glucose [nonfasting], blood urea nitrogen, total cholesterol, uric acid, alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, gamma glutamyl transpeptidase, alkaline phosphatase, bicarbonate, creatine kinase, total protein, albumin, total bilirubin, direct bilirubin, indirect bilirubin. Urinalysis tests performed include: protein, glucose, ketones, bilirubin, urobilinogen, nitrite content, pH, specific gravity, white blood cells, microscopic (red blood cells, white blood cells, casts, crystals).
Time Frame
From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)
Title
Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Vital Signs Value
Description
Low systolic blood pressure: < 90 and decrease (↓) of 30 mm Hg from baseline (BL) (ages 5-18); high systolic blood pressure: > 160 and increase (↑) of 30 mm Hg from BL (age 5-12), > 130 and ↑ of 30 mm Hg from BL (age 13-18). Low diastolic blood pressure: < 45 and ↓ of 12 mm Hg from BL (age 5-12), < 55 and ↓ of 12 mm Hg from BL (age 13-18), < 50 and ↓ of 15 mm Hg from BL; high diastolic blood pressure: > 85 and ↑ of 12 mm Hg from BL (ages 5-18). Low heart rate: < 80 and and ↓ of 30 beats per minute (bpm) from BL (age 5-12), < 60 and and ↓ of 30 bpm from BL (age 13-18), < 50 and and ↓ of 15 bpm from BL (age > 18); high heart rate: > 120 and ↑ of 30 bpm from BL (age 5-12), > 100 and ↑ of 30 bpm from BL (age 13-18), > 100 and ↑ of 15 bpm from BL (age > 18). Low oral body temperature: < 35.8° Celsius (age 5 to >18); high oral body temperature: > 38.1° C and ↑ 2° Celsius from BL (age 5-18).
Time Frame
From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)
Title
Number of Participants With Newly Diagnosed Physical Examination Abnormalities at Endpoint
Description
HEENT=head, eyes, ears, nose and throat.
Time Frame
From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)
Title
Infusion Site Evaluations
Description
The infusion site was assessed before treatment and within 30 minutes after the end of the infusion at each monthly treatment visit (or at early withdrawal if before Week 16). The infusion site was graded according to a 5-point scale as follows: 0=no tenderness at IV site, no erythema, no swelling, no induration, no purulence, no palpable venous cord; 1=tender IV site, no erythema, no swelling, no induration, no purulence, no palpable venous cord; 2=tender IV site with erythema, some degree of swelling, no induration, no purulence, no palpable venous cord; 3=tender IV site with erythema and swelling, with induration or palpable venous cord, no purulence; 4=frank vein thrombosis, along with all signs of grade 3 with purulence; IV may stop running because of thrombosis. After the 16-week visit, formal infusion site evaluations were not continued. However, any infusion site reactions were recorded as adverse events and graded as other adverse events.
Time Frame
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)
Title
Therapeutic Classification of Concomitant Medications in at Least 10% of Participants
Description
Number of participants receiving therapeutic classes of concomitant medications.
Time Frame
From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)
Secondary Outcome Measure Information:
Title
Mean Change From Baseline to Endpoint in Peak Esophageal Eosinophil Counts
Description
The mean change from baseline in esophageal eosinophil levels was described at week 16 or early withdrawal (if before week 16), using descriptive statistics. Baseline was defined as the last assessment before the first dose of reslizumab, which was the baseline of the double-blind study (NCT00538434) for patients who received reslizumab in the double blind study or the baseline of the open-label study for patients who received placebo during the double-blind study.
Time Frame
Baseline, Week 16 or early withdrawal (if before Week 16)
Title
Participant's EoE Predominant Symptoms Over Time
Description
The data from the patient's/parent's eosinophilic esophagitis (EoE) Symptom Assessment were used to assess the shift from baseline in Predominant Symptom Assessment. The predominant symptom of the participant's/parent's EoE Symptom Assessment was selected at the double-blind baseline visit and remained the same throughout this study. Using the EoE Symptom Assessment, the participant/parent or legal guardian rated the severity of the previous week's EoE symptoms as none, mild, moderate, severe, or very severe on a 5-point scale. Only the predominant symptom selected for each participant contributed to the overall analysis of the Predominant Symptom Assessment and the subgroup analyses of individual symptoms. Thus, for the Predominant Symptom Analysis, some patients had dysphagia assessed, while others had either abdominal/chest pain or vomiting/regurgitation assessed.
Time Frame
Every 3 weeks from Day 0 up to Week 42 (mean [SD] duration of treatment was 30.0 [5.89] months)
Title
Physician's EoE Global Assessment Over Time
Description
The data from the participant's/parent's EoE Symptom Assessment, in combination with other observations, were used by physicians to determine the Physician's EoE Global Assessment. All components of the patient's EoE Symptom Assessment were used by physicians to determine the Physician's EoE Global Assessment.
Time Frame
Every 3 weeks from Day 0 up to Week 42 (mean [SD] duration of treatment was 30.0 [5.89] months)
Title
Mean Change From Baseline to Endpoint in Selected Child Health Questionnaire (CHQ) Scores
Description
The Child Health Questionnaire comprises 50 items. Specific items are recoded and/or recalibrated. Raw scores for scales (domains calculated over one or more items) are then calculated following set algorithms. The raw scales are then transformed to 0 to 100 scores, except for Change in Health which remains a 1-5 score. Finally two summary measures are calculated based on weighted combinations of selected scales. The Global Health, Physical Summary Score and Psychosocial Summary Score were summarized. For each, scores range from 0 (higher disease activity) to 100 (lower disease activity); higher scores indicate better health.
Time Frame
Baseline through Endpoint (last visit; mean [SD] duration of treatment was 30.0 [5.89] months)
Title
Dietary Question Responses at Endpoint
Description
Number of participants answering that they either maintained or changed their diet from the beginning of the double-blind study (ie, NCT00538434). Additionally, for those participants who answered that they changed their diet from the beginning of the double-blind study (column 2), the number of participants in that group who changed by increasing the consistency of their food ('Increased consistency') and the percentage that changed by eating foods that previously worsened EoE ('Added foods'). (Note that these 2 categories are not mutually exclusive, so that someone could have both increased the consistency of the food they were eating AND also eaten foods that previously worsened their EoE symptoms.)
Time Frame
Study endpoint (mean [SD] duration of treatment was 30.0 [5.89] months)
Title
Reslizumab Serum Concentrations
Description
Reslizumab serum concentrations obtained in this study were included in ongoing and separate population pharmacokinetic analyses. The Number of Participants Analyzed reflects the number of participants who had concentrations measured following that dose level. Since some participants started on 1 mg/kg and later increased to 2 mg/kg (and are therefore represented in more than one column), the number of participants in each column add up to a greater number than the total in the overall column, which reflects the total number of participants with measurable concentration data in this study. The number of concentrations summarized for that dose level represents more than one concentration per participant in most cases.
Time Frame
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.
Title
Number of Participants With >/= 1 Confirmed Positive Value for Anti-drug Antibodies (ADA)
Description
Using a validated enzyme-linked immunosorbent assay (ELISA), the number of participants who had at least 1 confirmed positive value for ADA, either on day 0 after having received reslizumab in the double-blind study Res-05-0002 (NCT00538434) or during the course of the open-label study.
Time Frame
From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sponsor's Medical Expert, MD
Organizational Affiliation
Cephalon
Official's Role
Study Director
Facility Information:
Facility Name
The Children's Hospital of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Arizona Dept. of Pediatrics
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Arkansas Children's Hospital/University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Kaiser Permanente Hospital- Pediatric Gastroenterology
City
Hayward
State/Province
California
ZIP/Postal Code
94545
Country
United States
Facility Name
Children'S Hospital of Orange County Pediatric Subspecialty Faculty Division of Allergy and Asthma
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Pediatric Allergy/Immunology
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Children's Hospital of San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Denver Childrens At Aurora, Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
1st Allergy and Clinical Research Center
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Thomas Jefferson University Medical College
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
Children's Center for Digestive Health Care
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Children'S Memorial Hospital Division of Gastroenterology Hepatology & Nutrition
City
Chicago
State/Province
Illinois
ZIP/Postal Code
66014
Country
United States
Facility Name
Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Tuft's Floating Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Minnesota Gastroenterology
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
Saint Louis University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Creighton University Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Las Vegas Pediatric Gastroenterology Associates
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
South Jersey Pediatric Gastroenterology
City
Mays Landing
State/Province
New Jersey
ZIP/Postal Code
08330
Country
United States
Facility Name
Mount Sinai School of Medicine, Pediatrics
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
State University of New York (SUNY)
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Center for Digestive Allergic and Immunologic Diseases
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Pediatric Allergy and Immunology of Duke Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27720
Country
United States
Facility Name
Cincinnati Children's
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Greenville Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
University of Texas Southwest Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Utah School of Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
Children's Pavilion
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0264
Country
United States
Facility Name
Carilion Medical Center for Children
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24013
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Pediatric Allergy and Immunology
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
Facility Name
University of Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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