Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis

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

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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