Efficacy and Safety of QAX576 in Patients With Eosinophilic Esophagitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Brief Summary

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This study is designed to investigate the effects of a 12 week course of intravenous QAX576 6mg/kg every 4 weeks in reducing the number of eosinophils in the esophagus of EoE patients by 75% or greater when compared with baseline.

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Detailed Description

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Conditions

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Eosinophilic Esophagitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

QAX576 placebo

Intervention Type DRUG

QAX576

Group Type ACTIVE_COMPARATOR

QAX576

Intervention Type DRUG

Interventions

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QAX576 placebo

Intervention Type DRUG

QAX576

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males and females aged 18-50 with symptomatic eosinophilic esophagitis
* Female subjects must be women of non child bearing potential.
* Elimination diet must have been tried.
* Treatment for at least two months prior to enrollment on a protocol pump inhibitor .
* Appropriate contraception must be used by males, (e.g., spermicidal gel plus condom)
* Must be able to communicate well with the investigator, to understand and comply with the requirements of the study.
* Understand and sign the written informed consent.

Exclusion Criteria

* Have received corticosteroids within 3 months before starting the study for any symptoms.
* Any other eosinophilic disorders.
* History of clinical schistosomiasis, or having travelled within the preceding 6 months to an area with endemic schistosomiasis, including but not limited to Southeast and Southwest Asia, South America and Africa. Travel to these areas must not be planned for at least 6 months after the last dose.
* Donation or loss of 400 ml or more of blood within eight (8) weeks prior to initial dosing.
* History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
* History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No