Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis
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
1 other identifier
interventional
100
3 countries
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2014
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2014
CompletedFirst Posted
Study publicly available on registry
March 28, 2014
CompletedStudy Start
First participant enrolled
August 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 17, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2017
CompletedMay 9, 2017
May 1, 2017
1.5 years
March 25, 2014
May 8, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Eosinophil Count
Week 16
Study Arms (3)
RPC4046 Low Dose
EXPERIMENTALintravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, low dose
RPC4046 High Dose
EXPERIMENTALintravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, high dose
Placebo
PLACEBO COMPARATORintravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Histologic evidence of EoE
- Clinical symptoms of EoE including dysphagia
You may not qualify if:
- Primary causes of esophageal eosinophilia other than EoE
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (30)
Mayo Clinic - Arizona
Scottsdale, Arizona, 85259, United States
Desert Sun Clinical Research, LLC
Tucson, Arizona, 85710, United States
Alliance Clinical Research
Oceanside, California, 92056, United States
Precision Research Institute, LLC
San Diego, California, 92114, United States
University of Colorado School of Medicine
Aurora, Colorado, 80045, United States
Connecticut Clinical Research Foundation
Bristol, Connecticut, 06010, United States
University of Florida
Gainesville, Florida, 32608, United States
Borland-Groover Clinic
Jacksonville, Florida, 32256, United States
Children's Center for Digestive Healthcare
Atlanta, Georgia, 30342, United States
Grand Teton Research Group
Idaho Falls, Idaho, 83404, United States
Northwestern University-Feinberg School of Medicine
Chicago, Illinois, 60611, United States
Southwest Gastroenterology
Oak Lawn, Illinois, 60453, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Gastroenterology and Hepatology Service Walter Reed National Military Medical Center
Bethesda, Maryland, 20889, United States
Metropolitan Gastroenterology Group Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
West Michigan Clinical Research Center Gastroenterology Associates of Western Michigan
Wyoming, Michigan, 49519, United States
Minnesota Gastroenterology
Plymouth, Minnesota, 55446, United States
GI Associates and Endoscopy Center-GI Clinical Research Department
Flowood, Mississippi, 39232, United States
Darthmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, 28801, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Great Lakes Gastroenterology Research
Mentor, Ohio, 44060, United States
University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
Vanderbilt University
Nashville, Tennessee, 37212, United States
University of Utah Division of Gastroenterology
Salt Lake City, Utah, 84132, United States
Gastrointestinal Research Group, University of Calgary Health
Calgary, Alberta, T2N 4Z6, Canada
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, 1011, Switzerland
Swiss EoE Clinic
Olten, 4600, Switzerland
Related Publications (3)
Caldwell JM, Ballaban AY, Li J, Maddux R, Harris S, Dellon ES, Rothenberg ME. Cendakimab (anti-IL-13) administration improves esophageal gene expression in eosinophilic esophagitis. J Allergy Clin Immunol. 2026 Jan;157(1):118-130.e7. doi: 10.1016/j.jaci.2025.08.032. Epub 2025 Oct 9.
PMID: 41067281DERIVEDDellon 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.
PMID: 32205221DERIVEDHirano 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.
PMID: 30395812DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2014
First Posted
March 28, 2014
Study Start
August 31, 2014
Primary Completion
February 17, 2016
Study Completion
January 30, 2017
Last Updated
May 9, 2017
Record last verified: 2017-05