Clinical Trials Logo
  1. Home
  2. Eosinophilic Esophagitis
  3. NCT02098473
  4. Details
NCT02098473 Clinical Trial

Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis

Eosinophilic Esophagitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02098473
Other study ID # RPC02-201
Secondary ID
Status Completed
Phase Phase 2
First received March 25, 2014
Last updated May 8, 2017
Start date August 31, 2014
Est. completion date January 30, 2017

Study information
Verified date May 2017
Source Celgene
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date January 30, 2017
Est. primary completion date February 17, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Histologic evidence of EoE

- Clinical symptoms of EoE including dysphagia

Exclusion Criteria:

- Primary causes of esophageal eosinophilia other than EoE

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• RPC4046

• Placebo

Locations
Country Name City State
Canada Gastrointestinal Research Group, University of Calgary Health Calgary Alberta
Switzerland Centre Hospitalier Universitaire Vaudois (CHUV) Lausanne
Switzerland Swiss EoE Clinic Olten
United States Asheville Gastroenterology Associates, PA Asheville North Carolina
United States Children's Center for Digestive Healthcare Atlanta Georgia
United States University of Colorado School of Medicine Aurora Colorado
United States Gastroenterology and Hepatology Service Walter Reed National Military Medical Center Bethesda Maryland
United States Connecticut Clinical Research Foundation Bristol Connecticut
United States University of North Carolina Chapel Hill North Carolina
United States Metropolitan Gastroenterology Group Chevy Chase Clinical Research Chevy Chase Maryland
United States Northwestern University-Feinberg School of Medicine Chicago Illinois
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio
United States GI Associates and Endoscopy Center-GI Clinical Research Department Flowood Mississippi
United States University of Florida Gainesville Florida
United States Grand Teton Research Group Idaho Falls Idaho
United States Indiana University Indianapolis Indiana
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States Borland-Groover Clinic Jacksonville Florida
United States Darthmouth Hitchcock Medical Center Lebanon New Hampshire
United States Great Lakes Gastroenterology Research Mentor Ohio
United States Vanderbilt University Nashville Tennessee
United States Southwest Gastroenterology Oak Lawn Illinois
United States Alliance Clinical Research Oceanside California
United States University of Pennsylvania Perelman Center for Advanced Medicine Philadelphia Pennsylvania
United States Minnesota Gastroenterology Plymouth Minnesota
United States University of Utah Division of Gastroenterology Salt Lake City Utah
United States Precision Research Institute, LLC San Diego California
United States Mayo Clinic - Arizona Scottsdale Arizona
United States Desert Sun Clinical Research, LLC Tucson Arizona
United States West Michigan Clinical Research Center Gastroenterology Associates of Western Michigan Wyoming Michigan

Sponsors (1)
Lead Sponsor Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Canada,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean Eosinophil Count Week 16
See also
  Status Clinical Trial Phase
Completed NCT03382678 - CEGIR 7807: Validation of Online Cohort of EGID Patients Enrolled in RDCRN CEGIR Contact Registry
Completed NCT05083312 - Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial Phase 3
Completed NCT04593251 - Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis Phase 1
Completed NCT03633617 - Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE) Phase 3
Completed NCT04941742 - The Use of Fractionated Exhaled Nitric Oxide in the Diagnosis and Assessment of Disease Activity of Eosinophilic Esophagitis (Validation Phase)
Terminated NCT04543409 - A Study of Benralizumab in Patients With Eosinophilic Esophagitis Phase 3
Terminated NCT02314455 - Esophageal Absorption in EoE N/A
Completed NCT01953575 - Mucosal Impedance and Eosinophilic Esophagitis N/A
Completed NCT01386112 - Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis Phase 1/Phase 2
Recruiting NCT04991935 - Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis Phase 3
Not yet recruiting NCT05896891 - San Raffaele EoE Biobank
Active, not recruiting NCT05482256 - A Study of Detergents in the Pathogenesis of Eosinophilic Esophagitis N/A
Recruiting NCT05485155 - Zemaira Eosinophilic Esophagitis Pilot Study Phase 2
Recruiting NCT04149470 - Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis Assessed by Transnasal Endoscopy (TNE) Phase 4
Recruiting NCT04416217 - Eosinophilic Esophagitis Steroid Safety Study
Completed NCT05084963 - A Study to Assess the Efficacy, Safety and Tolerability of IRL201104 in Adults With Active Eosinophilic Esophagitis Phase 2
Completed NCT02579876 - Milk Patch for Eosinophilic Esophagitis Phase 2
Recruiting NCT02331849 - Esophageal Motility in Eosinophilic Esophagitis Evaluated by High Resolution Manometry. N/A
Active, not recruiting NCT02202590 - Using Spectrally Encoded Confocal Microscopy (SECM) to Image the Esophagus N/A
Active, not recruiting NCT05176249 - Prospective Database for Eosinophilic Esophagitis (EoE) of Pediatric Population