Clinical Trial: Efficacy and Safety of QAX576 in Patients With Eosinophilic Esophagitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Double Blinded Randomized Placebo-controlled Trial of Intravenous QAX576 in the Treatment of Eosinophilic Esophagitis (EoE)
Brief Summary: 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.
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Novartis
Dates:
Date Received: November 25, 2009
Date Started: November 2009
Date Completion:
Last Updated: November 21, 2013
Last Verified: November 2013
