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Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis

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Celgene

Status and phase

Completed
Phase 2

Conditions

Eosinophilic Esophagitis

Treatments

Drug: RPC4046
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02098473
RPC02-201

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Primary causes of esophageal eosinophilia other than EoE

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

100 participants in 3 patient groups, including a placebo group

RPC4046 Low Dose
Experimental group
Description:
intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, low dose
Treatment:
Drug: RPC4046
RPC4046 High Dose
Experimental group
Description:
intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, high dose
Treatment:
Drug: RPC4046
Placebo
Placebo Comparator group
Description:
intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks
Treatment:
Drug: Placebo

Trial contacts and locations

30

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Data sourced from clinicaltrials.gov

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