Eosinophilic Esophagitis
Conditions
Keywords
Esophagitis, Digestive System Diseases, Esophageal disorder, Eosinophilic esophagitis
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.
Interventions
DRUGQAX576 placebo
DRUGQAX576
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed