Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis
- Registration Number
- NCT02098473
- Lead Sponsor
- Celgene
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Histologic evidence of EoE
- Clinical symptoms of EoE including dysphagia
- Primary causes of esophageal eosinophilia other than EoE
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RPC4046 High Dose RPC4046 intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, high dose Placebo Placebo intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks RPC4046 Low Dose RPC4046 intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, low dose
- Primary Outcome Measures
Name Time Method Mean Eosinophil Count Week 16
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (30)
West Michigan Clinical Research Center Gastroenterology Associates of Western Michigan
🇺🇸Wyoming, Michigan, United States
Metropolitan Gastroenterology Group Chevy Chase Clinical Research
🇺🇸Chevy Chase, Maryland, United States
GI Associates and Endoscopy Center-GI Clinical Research Department
🇺🇸Flowood, Mississippi, United States
Darthmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Mayo Clinic - Arizona
🇺🇸Scottsdale, Arizona, United States
Alliance Clinical Research
🇺🇸Oceanside, California, United States
Connecticut Clinical Research Foundation
🇺🇸Bristol, Connecticut, United States
Desert Sun Clinical Research, LLC
🇺🇸Tucson, Arizona, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Borland-Groover Clinic
🇺🇸Jacksonville, Florida, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Minnesota Gastroenterology
🇺🇸Plymouth, Minnesota, United States
Great Lakes Gastroenterology Research
🇺🇸Mentor, Ohio, United States
Gastrointestinal Research Group, University of Calgary Health
🇨🇦Calgary, Alberta, Canada
Centre Hospitalier Universitaire Vaudois (CHUV)
🇨🇭Lausanne, Switzerland
Swiss EoE Clinic
🇨🇭Olten, Switzerland
Precision Research Institute, LLC
🇺🇸San Diego, California, United States
University of Colorado School of Medicine
🇺🇸Aurora, Colorado, United States
Children's Center for Digestive Healthcare
🇺🇸Atlanta, Georgia, United States
Grand Teton Research Group
🇺🇸Idaho Falls, Idaho, United States
Northwestern University-Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Southwest Gastroenterology
🇺🇸Oak Lawn, Illinois, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Gastroenterology and Hepatology Service Walter Reed National Military Medical Center
🇺🇸Bethesda, Maryland, United States
Asheville Gastroenterology Associates, PA
🇺🇸Asheville, North Carolina, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
University of Pennsylvania Perelman Center for Advanced Medicine
🇺🇸Philadelphia, Pennsylvania, United States
University of Utah Division of Gastroenterology
🇺🇸Salt Lake City, Utah, United States