drugset / Trial / NCT01759056
Evaluation of an Oral Anti-TNF Antibody in Patients With Active Ulcerative Colitis
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to evaluate the safety and tolerability as well as the pharmacodynamic effects of multiple doses of AVX-470 administered orally in patients with active ulcerative colitis.
Timeline
- Start
- 2013-02
- Primary completion
- 2013-12
- Completion
- 2013-12
Publications
- Harris MS, Hartman D, Lemos BR, Erlich EC, Spence S, Kennedy S, Ptak T, Pruitt R, Vermeire S, Fox BS. AVX-470, an Orally Delivered Anti-Tumour Necrosis Factor Antibody for Treatment of Active Ulcerative Colitis: Results of a First-in-Human Trial. J Crohns Colitis. 2016 Jun;10(6):631-40. doi: 10.1093/ecco-jcc/jjw036. Epub 2016 Jan 28.
- Hartman DS, Tracey DE, Lemos BR, Erlich EC, Burton RE, Keane DM, Patel R, Kim S, Bhol KC, Harris MS, Fox BS. Effects of AVX-470, an Oral, Locally Acting Anti-Tumour Necrosis Factor Antibody, on Tissue Biomarkers in Patients with Active Ulcerative Colitis. J Crohns Colitis. 2016 Jun;10(6):641-9. doi: 10.1093/ecco-jcc/jjw026. Epub 2016 Jan 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | AVX 470 | Protein / enzyme biologic | 0.2 g | Oral |
| Comparator | AVX 470 | Protein / enzyme biologic | 1.6 g | Oral |
| Comparator | AVX 470 | Protein / enzyme biologic | 3.5 g | Oral |