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Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis

NCT ID: NCT02098473

Last Updated: 2017-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-01-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Eosinophilic Esophagitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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RPC4046 Low Dose

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

Group Type EXPERIMENTAL

RPC4046

Intervention Type DRUG

RPC4046 High Dose

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

Group Type EXPERIMENTAL

RPC4046

Intervention Type DRUG

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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RPC4046

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Primary causes of esophageal eosinophilia other than EoE
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mayo Clinic - Arizona

Scottsdale, Arizona, United States

Site Status

Desert Sun Clinical Research, LLC

Tucson, Arizona, United States

Site Status

Alliance Clinical Research

Oceanside, California, United States

Site Status

Precision Research Institute, LLC

San Diego, California, United States

Site Status

University of Colorado School of Medicine

Aurora, Colorado, United States

Site Status

Connecticut Clinical Research Foundation

Bristol, Connecticut, United States

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

Borland-Groover Clinic

Jacksonville, Florida, United States

Site Status

Children's Center for Digestive Healthcare

Atlanta, Georgia, United States

Site Status

Grand Teton Research Group

Idaho Falls, Idaho, United States

Site Status

Northwestern University-Feinberg School of Medicine

Chicago, Illinois, United States

Site Status

Southwest Gastroenterology

Oak Lawn, Illinois, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status

Gastroenterology and Hepatology Service Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Site Status

Metropolitan Gastroenterology Group Chevy Chase Clinical Research

Chevy Chase, Maryland, United States

Site Status

West Michigan Clinical Research Center Gastroenterology Associates of Western Michigan

Wyoming, Michigan, United States

Site Status

Minnesota Gastroenterology

Plymouth, Minnesota, United States

Site Status

GI Associates and Endoscopy Center-GI Clinical Research Department

Flowood, Mississippi, United States

Site Status

Darthmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Asheville Gastroenterology Associates, PA

Asheville, North Carolina, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Great Lakes Gastroenterology Research

Mentor, Ohio, United States

Site Status

University of Pennsylvania Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

Site Status

Vanderbilt University

Nashville, Tennessee, United States

Site Status

University of Utah Division of Gastroenterology

Salt Lake City, Utah, United States

Site Status

Gastrointestinal Research Group, University of Calgary Health

Calgary, Alberta, Canada

Site Status

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, , Switzerland

Site Status

Swiss EoE Clinic

Olten, , Switzerland

Site Status

Countries

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United States Canada Switzerland

References

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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. 2025 Oct 7:S0091-6749(25)01020-6. doi: 10.1016/j.jaci.2025.08.032. Online ahead of print.

Reference Type DERIVED
PMID: 41067281 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32205221 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30395812 (View on PubMed)

Other Identifiers

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RPC02-201

Identifier Type: -

Identifier Source: org_study_id

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