The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Evaluation of an Oral Anti-TNF Antibody in Patients With Active Ulcerative Colitis
Official Title: A Multicenter, Double-Blind, Placebo-Controlled, Ascending-Dose, Repeat-Dose Safety and Pharmacokinetic Investigation of a Delayed-Release, Enteric-Coated Capsule Formulation of AVX 470 [Anti-TNF (Tumor Necrosis Factor) Globulin (Bovine)] in Patients With Active Ulcerative Colitis
Study ID: NCT01759056
Brief 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.
Detailed Description: There is a significant unmet medical need for effective oral pharmacologic therapies for inflammatory bowel diseases such as ulcerative colitis. Current anti-TNF therapies, including infliximab and adalimumab, are effective treatments for these conditions, but they must be administered by intravenous or subcutaneous injection. The major safety concerns associated with the use of injectable anti-TNF therapies are infection, demyelinating disease, and lymphoma, all of which are the result of systemic exposure. These uncommon but serious side effects have limited the use of systemic anti-TNF antibody therapy to patients with severe disease that have failed to respond to first-line treatments. AVX-470 is purified immunoglobulin (Ig) from the colostrum (early milk) of cows immunized with recombinant human tumor necrosis factor (rhTNF). AVX-470 is formulated in delayed-release enteric-coated capsules designed to protect the capsule contents from gastric acids following oral administration and to provide localized delivery to sites of inflammation in the distal intestine. Prior clinical experience with bovine Ig therapies in other human diseases suggests that AVX-470 will not be absorbed to any significant extent, meaning that systemic exposure could be minimized. The development of oral anti-TNF therapy targeting local intestinal disease activity might reduce the risks associated with injectable anti-TNF therapy and allow the convenience of oral dosing. The present study is a first-in-human, Phase 1 clinical study. It is primarily intended to evaluate the safety and tolerability of multiple doses of AVX-470 administered orally to patients with active ulcerative colitis. Animal models of ulcerative colitis using a mouse-specific TNF antibody derived from bovine colostrum demonstrated a 50% or more reduction in tissue TNF, TNF-messenger ribonucleic acid (mRNA), interleukin (IL)-6 mRNA, and myeloperoxidase and lowering of colonic inflammatory activity. Twenty-eight-day toxicology studies demonstrated no clinical or histologic findings in exposures above the intended clinical dose range.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Anaheim Clinical Trials, Anaheim, California, United States
Rocky Mountain Gastroenterology Associates, Lakewood, Colorado, United States
Shafran Gastroenterology Center, Winter Park, Florida, United States
Chevy Chase Clinical Research, Chevy Chase, Maryland, United States
Clinical Research Institute of Michigan, Chesterfield, Michigan, United States
Center for Digestive and Liver Disease, Mexico, Missouri, United States
Remington-Davis, Inc., Columbus, Ohio, United States
Oklahoma Foundation for Digestive Research, Oklahoma City, Oklahoma, United States
Nashville Medical Research Institute, Nashville, Tennessee, United States
Gastro-Enterologie, Gent, , Belgium
Gastro-enterologie, Leuven, , Belgium
The Northern Alberta Clinical Trials and Research Centre, Edmonton, Alberta, Canada
Toronto Digestive Disease Associates, Toronto, Ontario, Canada
Semmelweis Egyetem, Budapest, , Hungary
Debreceni Egyetem Orvos- és Egészségtudományi Centrum, Debrecen, , Hungary
Kenézy Kórház Rendelöintézet Egészségügyi Szolgáltató Kft., Debrecen, , Hungary
Name: Scott Harris, MD
Affiliation: Avaxia Biologics, Incorporated
Role: STUDY_DIRECTOR