Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis

May 8, 2017 updated by: Celgene

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Gastrointestinal Research Group, University of Calgary Health
  • Switzerland
      • Lausanne, Switzerland, 1011
        • Centre Hospitalier Universitaire Vaudois (Chuv)
      • Olten, Switzerland, 4600
        • Swiss EoE Clinic
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic - Arizona
      • Tucson, Arizona, United States, 85710
        • Desert Sun Clinical Research, LLC
    • California
      • Oceanside, California, United States, 92056
        • Alliance Clinical Research
      • San Diego, California, United States, 92114
        • Precision Research Institute, LLC
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado School of Medicine
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Connecticut Clinical Research Foundation
    • Florida
      • Gainesville, Florida, United States, 32608
        • University of Florida
      • Jacksonville, Florida, United States, 32256
        • Borland-Groover Clinic
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Children's Center for Digestive Healthcare
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Grand Teton Research Group
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University-Feinberg School of Medicine
      • Oak Lawn, Illinois, United States, 60453
        • Southwest Gastroenterology
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Maryland
      • Bethesda, Maryland, United States, 20889
        • Gastroenterology and Hepatology Service Walter Reed National Military Medical Center
      • Chevy Chase, Maryland, United States, 20815
        • Metropolitan Gastroenterology Group Chevy Chase Clinical Research
    • Michigan
      • Wyoming, Michigan, United States, 49519
        • West Michigan Clinical Research Center Gastroenterology Associates of Western Michigan
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • Minnesota Gastroenterology
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • GI Associates and Endoscopy Center-GI Clinical Research Department
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Darthmouth Hitchcock Medical Center
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Asheville Gastroenterology Associates, PA
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
      • Mentor, Ohio, United States, 44060
        • Great Lakes Gastroenterology Research
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Perelman Center for Advanced Medicine
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Division of Gastroenterology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologic evidence of EoE
  • Clinical symptoms of EoE including dysphagia

Exclusion Criteria:

  • Primary causes of esophageal eosinophilia other than EoE

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: RPC4046 Low Dose
intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, low dose
Drug: RPC4046
EXPERIMENTAL: RPC4046 High Dose
intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, high dose
Drug: RPC4046
PLACEBO_COMPARATOR: Placebo
intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Eosinophil Count
Time Frame: Week 16
Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 31, 2014

Primary Completion (ACTUAL)

February 17, 2016

Study Completion (ACTUAL)

January 30, 2017

Study Registration Dates

First Submitted

March 25, 2014

First Submitted That Met QC Criteria

March 25, 2014

First Posted (ESTIMATE)

March 28, 2014

Study Record Updates

Last Update Posted (ACTUAL)

May 9, 2017

Last Update Submitted That Met QC Criteria

May 8, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RPC02-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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