Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT02098473 Completed March 28, 2014 May 9, 2017

study description
Brief Summary

The purpose of this study is to determine the effective dose(s) of RPC4046 in the treatment of Eosinophilic Esophagitis (EoE). This trial consists of two phases: 16 weeks of double-blind treatment and 52 weeks of open-label extension.

Condition or Disease: Eosinophilic Esophagitis
Intervention/treatment: Drug: RPC4046
Drug: Placebo
Phase: Phase 2
Detailed Description

N/A


study design
Study Type: Interventional
Estimated Enrollment : 100 participants
Intervention Model : Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase2, Multi-Center, Multi-national, Randomized, Double-blind, Placebo-controlled Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of RPC4046 in Adult Subjects With Eosinophilic Esophagitis
Actual Study Start Date: August 2014
Actual Primary Completion Date: February 2016
Actual Study Completion Date: January 2017

Arms and interventions
Arm Intervention/treatment
Experimental: RPC4046 High Dose
intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, high dose
Drug: RPC4046
Experimental: RPC4046 Low Dose
intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, low dose
Drug: RPC4046
Placebo Comparator: Placebo
intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks
Drug: Placebo
outcome measures
Primary Outcome Measures: 1. Mean Eosinophil Count [ Time Frame: Week 16 ]

Eligibility Criteria
Ages Eligible for Study: 18 to 65 Years (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Histologic evidence of EoE

- Clinical symptoms of EoE including dysphagia

Exclusion Criteria:

- Primary causes of esophageal eosinophilia other than EoE


Contacts and Locations
Contacts
Locations
United States, Arizona Mayo Clinic - Arizona Scottsdale
United States, Arizona Desert Sun Clinical Research, LLC Tucson
United States, California Alliance Clinical Research Oceanside
United States, California Precision Research Institute, LLC San Diego
United States, Colorado University of Colorado School of Medicine Aurora
United States, Connecticut Connecticut Clinical Research Foundation Bristol
United States, Florida University of Florida Gainesville
United States, Florida Borland-Groover Clinic Jacksonville
United States, Georgia Children's Center for Digestive Healthcare Atlanta
United States, Idaho Grand Teton Research Group Idaho Falls
United States, Illinois Northwestern University-Feinberg School of Medicine Chicago
United States, Illinois Southwest Gastroenterology Oak Lawn
United States, Indiana Indiana University Indianapolis
United States, Iowa University of Iowa Hospitals and Clinics Iowa City
United States, Maryland Gastroenterology and Hepatology Service Walter Reed National Military Medical Center Bethesda
United States, Maryland Metropolitan Gastroenterology Group Chevy Chase Clinical Research Chevy Chase
United States, Michigan West Michigan Clinical Research Center Gastroenterology Associates of Western Michigan Wyoming
United States, Minnesota Minnesota Gastroenterology Plymouth
United States, Mississippi GI Associates and Endoscopy Center-GI Clinical Research Department Flowood
United States, New Hampshire Darthmouth Hitchcock Medical Center Lebanon
United States, North Carolina Asheville Gastroenterology Associates, PA Asheville
United States, North Carolina University of North Carolina Chapel Hill
United States, Ohio Cincinnati Children's Hospital Medical Center Cincinnati
United States, Ohio Great Lakes Gastroenterology Research Mentor
United States, Pennsylvania University of Pennsylvania Perelman Center for Advanced Medicine Philadelphia
United States, Tennessee Vanderbilt University Nashville
United States, Utah University of Utah Division of Gastroenterology Salt Lake City
Canada, Alberta Gastrointestinal Research Group, University of Calgary Health Calgary
Switzerland Centre Hospitalier Universitaire Vaudois (CHUV) Lausanne
Switzerland Swiss EoE Clinic Olten
Sponsors and Collaborators
Celgene
Investigator
More Information
Responsible Party : Celgene
ClinicalTrials.gov Identifier : NCT02098473     
Other Study ID Numbers : RPC02-201
First Posted : March 28, 2014
Last Update Posted : May 9, 2017
Last Verified : May 2017
Additional relevant MeSH terms :
Esophagitis
Eosinophilic Esophagitis