Open-Label Extension Study of Reslizumab in Pediatric Subjects With Eosinophilic Esophagitis

Ception Therapeutics

Status and phase: Completed; Phase 3

Conditions: Eosinophilic Esophagitis

Treatments: Drug: reslizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00635089

Res-5-0004

Details and patient eligibility

About

This study is an open-label study where all subjects will receive active drug, reslizumab. Subjects are able to enter this trial only through completion of study Res-05-0002 (NCT00538434).

The goal of the study is to show longer term safety and efficacy in pediatric subjects who have eosinophilic esophagitis.

Full description

Subjects will enter this open-label extension study after completing the placebo-controlled, double-blind study Res-5-0002 (NCT00538434). The end of study visit for Res-05-0002 will serve as the screening visit for this trial.

All subjects will receive reslizumab and be followed by their principal investigators in an unblinded fashion. Visits and administration of reslizumab will be monthly.

Enrollment: 190 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent
• Received at least two doses of study drug in Study Res-05-0002 (NCT00538434)
• Did not withdraw from Study Res-05-0002 due to drug related adverse event
• Completed End of Treatment Visit for Study Res-05-0002

Exclusion criteria

• Pregnant or nursing females
• Concurrent Immunodeficiency
• Current use of immunosuppressive drugs
• Did not tolerate study drug in Study Res-05-0002

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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190 participants in 1 patient group

Open-Label Reslizumab

Other group

Description:

Open-label reslizumab intravenous (IV) infusion at an initial dose of 1 mg/kg monthly

Treatment:

Drug: reslizumab