Efficacy and Safety of QAX576 in Patients With Eosinophilic Esophagitis

Study Overview
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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.

Official Title
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A Double Blinded Randomized Placebo-controlled Trial of Intravenous QAX576 in the Treatment of Eosinophilic Esophagitis (EoE)

Conditions
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Eosinophilic Esophagitis

Intervention / Treatment
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* Drug: QAX576 placebo
* Drug: QAX576


Participation Criteria
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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. Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: QAX576 placebo<br> <br> |
| Active Comparator: QAX576<br> | Drug: QAX576<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint in this study is the number of patients (responder) with a reduction of 75% or more in eosinophils per HPF (distal or proximal esophagus) from baseline to week 13. |  | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To ascertain the effect of QAX576 in the frequency and severity of the symptoms of EoE. |  | 34 weeks | 
| To investigate the safety and tolerability of QAX576 in patients with EoE. |  | 34 weeks | 
| To establish the duration of clinical benefit after a 12 week course of therapy. |  | 34 weeks | 
| PK/PD relationship between blood levels of QAX576 and IL- 13 dependent gene expression in esophageal biopsies and soluble biomarkers, inflammatory and fibrotic markers within esophageal biopsies and activation markers expressed on peripheral |  | 34 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eosinophilic esophagitis, Esophagitis, Digestive System Diseases, Esophageal disorder