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Currently, you can access the following clinical trials being conducted worldwide:

354,475 studies
in
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 12/02/2020.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 12/02/2020.

Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis

Clinicaltrials.gov identifier NCT02098473

Recruitment Status Completed

First Posted March 28, 2014

Last update posted May 9, 2017

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.

  • Condition or Disease:Eosinophilic Esophagitis
  • Intervention/Treatment: Drug: RPC4046
    Drug: Placebo
  • Phase: Phase 2
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 100 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • 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
  • Actual Study Start Date: August 2014
  • Actual Primary Completion Date: February 2016
  • Actual Study Completion Date: January 2017
Arms and interventions
Arm Intervention/treatment
Experimental: RPC4046 High Dose
intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, high dose
Drug: RPC4046
Experimental: RPC4046 Low Dose
intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, low dose
Drug: RPC4046
Placebo Comparator: Placebo
intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks
Drug: Placebo
Outcome Measures
  • Primary Outcome Measures: 1. Mean Eosinophil Count [ Time Frame: Week 16 ]
Eligibility Criteria
  • Ages Eligible for Study: 18 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Histologic evidence of EoE

- Clinical symptoms of EoE including dysphagia

Exclusion Criteria:

- Primary causes of esophageal eosinophilia other than EoE

Contacts and Locations
Contacts
Locations
Show 30 Study Locations
Sponsors and Collaborators

Celgene

More Information
  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT02098473 History of Changes
  • Other Study ID Numbers: RPC02-201
  • First Posted: March 28, 2014 Key Record Dates
  • Last Update Posted: May 9, 2017
  • Last Verified: May 2017
  • Additional relevant MeSH terms: Esophagitis Eosinophilic Esophagitis