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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Ception Therapeutics )
ClinicalTrials.gov Identifier:
NCT00538434
First received: October 1, 2007
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Eosinophilic Esophagitis
Biological: Reslizumab
Other: Saline
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Efficacy and Safety Study of Reslizumab (CTx55700) in the Treatment of Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • esophageal eosinophil counts (co-primary) [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • EE Global Assessment (co-primary) [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • EE Predominant Symptom Assessment [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • Child Health Questionnaire [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]

Enrollment: 226
Study Start Date: February 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Reslizumab 1 mg/kg
Biological: Reslizumab
IV (in the vein) on Day 0 of each 28 days cycle (+/-7 days) Number of Cycles=4
Experimental: 2
Reslizumab 2 mg/kg
Biological: Reslizumab
IV (in the vein) on Day 0 of each 28 days cycle (+/-7 days) Number of Cycles=4
Experimental: 3
Reslizumab 3 mg/kg
Biological: Reslizumab
IV (in the vein) on Day 0 of each 28 days cycle (+/-7 days) Number of Cycles=4
Placebo Comparator: 4
Saline
Other: Saline
IV (in the vein) on Day 0 of each 28 days cycle (+/-7 days) Number of Cycles=4)

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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 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], 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00538434

  Show 37 Study Locations
Sponsors and Collaborators
Ception Therapeutics
Investigators
Study Director: Sponsor's Medical Expert, MD Cephalon (Ception)
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Ception Therapeutics )
ClinicalTrials.gov Identifier: NCT00538434     History of Changes
Other Study ID Numbers: Res-05-0002
Study First Received: October 1, 2007
Last Updated: August 16, 2013
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Teva Pharmaceutical Industries:
Eosinophilic Esophagitis
GERD
EE
Reslizumab
IL-5
Interleukin-5
Cinquil

Additional relevant MeSH terms:
Eosinophilic Esophagitis
Esophagitis
Digestive System Diseases
Eosinophilia
Esophageal Diseases
Gastroenteritis
Gastrointestinal Diseases
Hematologic Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Leukocyte Disorders

ClinicalTrials.gov processed this record on October 21, 2014