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RPC4046

Phase 2

Eosinophilic Esophagitis | Small molecule | Gastrointestinal |Bristol-Myers Squibb Company|Last Updated: May 9, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

RPC4046 · 1 trial · 1 indication

Phase 2 1
NCT02098473Dose Ranging Study of RPC4046 in Eosinophilic EsophagitisEosinophilic Esophagitis
COMPLETED100 Analytics
PHASE2COMPLETED
Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis
Eosinophilic EsophagitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean Eosinophil Count
Week 16
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RPC4046 Low DoseEXPERIMENTALintravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, low dose
RPC4046 High DoseEXPERIMENTALintravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, high dose
PlaceboPLACEBO_COMPARATORintravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks

Interventions

NameTypeDescription
RPC4046DRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites30

Inclusion Criteria: * Histologic evidence of EoE * Clinical symptoms of EoE including dysphagia Exclusion Criteria: * Primary causes of esophageal eosinophilia other than EoE

Countries:United StatesCanadaSwitzerland
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Frequently asked questions about RPC4046

What is RPC4046 used for in Eosinophilic Esophagitis?

RPC4046 is an investigational small molecule being developed for the treatment of Eosinophilic Esophagitis, a chronic allergic inflammatory condition of the esophagus. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes RPC4046?

RPC4046 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Eosinophilic Esophagitis.

What phase is RPC4046 in?

RPC4046 is in Phase 2 clinical development. It has completed one Phase 2 trial, and it remains an investigational drug that is not yet approved for any use. The completed trial was a dose-ranging study in patients with Eosinophilic Esophagitis.

What clinical trials is RPC4046 in?

RPC4046 has one completed clinical trial, identified as NCT02098473, titled "Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis." This Phase 2 study enrolled 100 participants and was conducted in the United States, Canada, and Switzerland.

Is RPC4046 FDA approved?

RPC4046 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Eosinophilic Esophagitis. The drug has completed a Phase 2 trial, but it has not received marketing approval from the FDA or any other regulatory agency.