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Spots Global Cancer Trial Database for Evaluation of an Oral Anti-TNF Antibody in Patients With Active Ulcerative Colitis

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Trial Identification

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

Interventions

AVX 470
Placebo

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Scott Harris, MD

Affiliation: Avaxia Biologics, Incorporated

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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