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Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02098473
Recruitment Status : Completed
First Posted : March 28, 2014
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Description
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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 Intervention/treatment Phase
Eosinophilic Esophagitis Drug: RPC4046 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
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 31, 2014
Actual Primary Completion Date : February 17, 2016
Actual Study Completion Date : January 30, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: RPC4046 Low Dose
intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, low dose
 Drug: RPC4046
Experimental: RPC4046 High Dose
intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, high 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
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Primary Outcome Measures :
  1. Mean Eosinophil Count [ Time Frame: Week 16 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02098473


Locations
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Sponsors and Collaborators
Celgene
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02098473    
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:
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Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
 Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases