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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
25
Stanford Medical Center and Lucile Packard Children's Hospital
Stanford, California, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Mayo Clinic
Minneota, Minnesota, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
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.
Time frame: 13 weeks
To ascertain the effect of QAX576 in the frequency and severity of the symptoms of EoE.
Time frame: 34 weeks
To investigate the safety and tolerability of QAX576 in patients with EoE.
Time frame: 34 weeks
To establish the duration of clinical benefit after a 12 week course of therapy.
Time frame: 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
Time frame: 34 weeks
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