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Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis

Primary Purpose

Eosinophilic Esophagitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
RPC4046
Placebo
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eosinophilic Esophagitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Primary causes of esophageal eosinophilia other than EoE

Sites / Locations

  • Mayo Clinic - Arizona
  • Desert Sun Clinical Research, LLC
  • Alliance Clinical Research
  • Precision Research Institute, LLC
  • University of Colorado School of Medicine
  • Connecticut Clinical Research Foundation
  • University of Florida
  • Borland-Groover Clinic
  • Children's Center for Digestive Healthcare
  • Grand Teton Research Group
  • Northwestern University-Feinberg School of Medicine
  • Southwest Gastroenterology
  • Indiana University
  • University of Iowa Hospitals and Clinics
  • Gastroenterology and Hepatology Service Walter Reed National Military Medical Center
  • Metropolitan Gastroenterology Group Chevy Chase Clinical Research
  • West Michigan Clinical Research Center Gastroenterology Associates of Western Michigan
  • Minnesota Gastroenterology
  • GI Associates and Endoscopy Center-GI Clinical Research Department
  • Darthmouth Hitchcock Medical Center
  • Asheville Gastroenterology Associates, PA
  • University of North Carolina
  • Cincinnati Children's Hospital Medical Center
  • Great Lakes Gastroenterology Research
  • University of Pennsylvania Perelman Center for Advanced Medicine
  • Vanderbilt University
  • University of Utah Division of Gastroenterology
  • Gastrointestinal Research Group, University of Calgary Health
  • Centre Hospitalier Universitaire Vaudois (CHUV)
  • Swiss EoE Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

RPC4046 Low Dose

RPC4046 High Dose

Placebo

Arm Description

intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, low dose

intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, high dose

intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks

Outcomes

Primary Outcome Measures

Mean Eosinophil Count

Secondary Outcome Measures

Full Information

First Posted
March 25, 2014
Last Updated
May 8, 2017
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT02098473
Brief Title
Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 31, 2014 (Actual)
Primary Completion Date
February 17, 2016 (Actual)
Study Completion Date
January 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RPC4046 Low Dose
Arm Type
Experimental
Arm Description
intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, low dose
Arm Title
RPC4046 High Dose
Arm Type
Experimental
Arm Description
intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, high dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks
Intervention Type
Drug
Intervention Name(s)
RPC4046
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Mean Eosinophil Count
Time Frame
Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologic evidence of EoE Clinical symptoms of EoE including dysphagia Exclusion Criteria: Primary causes of esophageal eosinophilia other than EoE
Facility Information:
Facility Name
Mayo Clinic - Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Desert Sun Clinical Research, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Alliance Clinical Research
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Precision Research Institute, LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
University of Colorado School of Medicine
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Connecticut Clinical Research Foundation
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Borland-Groover Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Children's Center for Digestive Healthcare
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Grand Teton Research Group
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Northwestern University-Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Southwest Gastroenterology
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Gastroenterology and Hepatology Service Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
Facility Name
Metropolitan Gastroenterology Group Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
West Michigan Clinical Research Center Gastroenterology Associates of Western Michigan
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Minnesota Gastroenterology
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
GI Associates and Endoscopy Center-GI Clinical Research Department
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Darthmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Asheville Gastroenterology Associates, PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Great Lakes Gastroenterology Research
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
University of Pennsylvania Perelman Center for Advanced Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
University of Utah Division of Gastroenterology
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Gastrointestinal Research Group, University of Calgary Health
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Centre Hospitalier Universitaire Vaudois (CHUV)
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Swiss EoE Clinic
City
Olten
ZIP/Postal Code
4600
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
32205221
Citation
Dellon ES, Collins MH, Rothenberg ME, Assouline-Dayan Y, Evans L, Gupta S, Schoepfer A, Straumann A, Safroneeva E, Rodriguez C, Minton N, Hua SY, Hirano I. Long-term Efficacy and Tolerability of RPC4046 in an Open-Label Extension Trial of Patients With Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2021 Mar;19(3):473-483.e17. doi: 10.1016/j.cgh.2020.03.036. Epub 2020 Mar 21.
Results Reference
derived
PubMed Identifier
30395812
Citation
Hirano I, Collins MH, Assouline-Dayan Y, Evans L, Gupta S, Schoepfer AM, Straumann A, Safroneeva E, Grimm M, Smith H, Tompkins CA, Woo A, Peach R, Frohna P, Gujrathi S, Penenberg DN, Li C, Opiteck GJ, Olson A, Aranda R, Rothenberg ME, Dellon ES; HEROES Study Group. RPC4046, a Monoclonal Antibody Against IL13, Reduces Histologic and Endoscopic Activity in Patients With Eosinophilic Esophagitis. Gastroenterology. 2019 Feb;156(3):592-603.e10. doi: 10.1053/j.gastro.2018.10.051. Epub 2018 Nov 2.
Results Reference
derived

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Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis

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