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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| QAX576 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QAX576 placebo | Drug |
| ||
| QAX576 |
| 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 |
| 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 | |
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Inclusion Criteria:
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Medical Center and Lucile Packard Children's Hospital | Stanford | California | 94305 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25226850 | Derived | Rothenberg ME, Wen T, Greenberg A, Alpan O, Enav B, Hirano I, Nadeau K, Kaiser S, Peters T, Perez A, Jones I, Arm JP, Strieter RM, Sabo R, Gunawardena KA. Intravenous anti-IL-13 mAb QAX576 for the treatment of eosinophilic esophagitis. J Allergy Clin Immunol. 2015 Feb;135(2):500-7. doi: 10.1016/j.jaci.2014.07.049. Epub 2014 Sep 13. |
| Label | URL |
|---|---|
| Results for CQAX576A2205 from the Novartis Clinical Trials website | View source |
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| ID | Term |
|---|---|
| D057765 | Eosinophilic Esophagitis |
| D004941 | Esophagitis |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D005759 | Gastroenteritis |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
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|
| 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 |
| Northwestern University Feinberg School of Medicine |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Mayo Clinic | Minneota | Minnesota | 55905 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Oral Alpan, 6210 Old Keene Mill Court, | Springfield | Virginia | 22152 | United States |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |