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

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 II Phase III

MedlinePlus related topics:

Esophagus Disorders

ChemIDplus related topics:

Sodium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Ception Therapeutics:

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 ]

Estimated Enrollment:	172
Study Start Date:	February 2008
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Reslizumab 1 mg/kg	Biological: Reslizumab IV (in the vein) on Day 0 of each 28 days cycle (+/-7 days) Number of Cycles=4
2: Experimental Reslizumab 2 mg/kg	Biological: Reslizumab IV (in the vein) on Day 0 of each 28 days cycle (+/-7 days) Number of Cycles=4
3: Experimental Reslizumab 3 mg/kg	Biological: Reslizumab IV (in the vein) on Day 0 of each 28 days cycle (+/-7 days) Number of Cycles=4
4: Placebo Comparator 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 two months 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

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

Contacts


Contact: Carol M Ward	215-907-1330 ext 1091	carol.ward@premier-research.com

Show 27 Study Locations

Sponsors and Collaborators

Ception Therapeutics

Investigators


Study Director:	H. Jeffery Wilkins, M.D.	Ception Therapeutics, Inc.

More Information

Responsible Party:	Ception Therapeutics ( H. Jeffrey Wilkins, M.D./ Senior Vice-President of Clinical Development )
Study ID Numbers:	Res-05-0002
First Received:	October 1, 2007
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00538434
Health Authority:	Canada: Health Canada; Canada: Ethics Review Committee; United States: Food and Drug Administration; United States: Institutional Review Board