Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis

Phase 2

Completed

• Conditions: Eosinophilic Esophagitis
• Interventions: Drug: RPC4046; Drug: Placebo

• Registration Number: NCT02098473
• Lead Sponsor: Celgene

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-25
• Study First Submitted QC: 2014-03-25
• Study First Posted: 2014-03-28
• Study Start: 2014-08-31
• Primary Completion: 2016-02-17
• Disposition First Submitted: 2016-11-10
• Disposition First Submitted QC: 2016-11-10
• Disposition First Posted: 2016-11-15
• Study Completion: 2017-01-30
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-08
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• Primary causes of esophageal eosinophilia other than EoE

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RPC4046 High Dose	RPC4046	intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, high dose
Placebo	Placebo	intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks
RPC4046 Low Dose	RPC4046	intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, low dose

Primary Outcome Measures

Name	Time	Method
Mean Eosinophil Count	Week 16

Trial Locations

Locations (30)

Mayo Clinic - Arizona; 🇺🇸 Scottsdale, Arizona, United States

Desert Sun Clinical Research, LLC; 🇺🇸 Tucson, Arizona, United States

Alliance Clinical Research; 🇺🇸 Oceanside, California, United States

Precision Research Institute, LLC; 🇺🇸 San Diego, California, United States

University of Colorado School of Medicine; 🇺🇸 Aurora, Colorado, United States

Connecticut Clinical Research Foundation; 🇺🇸 Bristol, Connecticut, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Borland-Groover Clinic; 🇺🇸 Jacksonville, Florida, United States

Children's Center for Digestive Healthcare; 🇺🇸 Atlanta, Georgia, United States

Grand Teton Research Group; 🇺🇸 Idaho Falls, Idaho, United States

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