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Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene
ClinicalTrials.gov Identifier:
NCT02098473
First received: March 25, 2014
Last updated: November 10, 2016
Last verified: November 2016

March 25, 2014
November 10, 2016
August 2014
February 2016   (Final data collection date for primary outcome measure)
Mean Eosinophil Count [ Time Frame: Week 16 ]
Mean Eosinophil Count [ Time Frame: Week 12 ]
Complete list of historical versions of study NCT02098473 on ClinicalTrials.gov Archive Site
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Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis
A Phase 2, 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
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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Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Eosinophilic Esophagitis
  • Drug: RPC4046
  • Drug: Placebo
  • Experimental: RPC4046 Low Dose
    intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, low dose
    Intervention: Drug: RPC4046
  • Experimental: RPC4046 High Dose
    intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, high dose
    Intervention: Drug: RPC4046
  • Placebo Comparator: Placebo
    intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
90
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February 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Primary causes of esophageal eosinophilia other than EoE
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Switzerland
 
 
NCT02098473
RPC02-201
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Celgene
Celgene
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Celgene
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP