Evaluation of an Oral Anti-TNF Antibody in Patients With Active Ulcerative Colitis

Completed · Phase 1 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT01759056

Run by

Avaxia Biologics, Incorporated

People needed

33

Starts

2013-02-01

Expected to finish

2013-12-01

Last updated by the study team

2014-03-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men or women aged 18 75, inclusive
• Established diagnosis of ulcerative colitis involving the sigmoid colon or proximal segments of bowel
• Total Mayo score between 5-12, inclusive, with endoscopic subscore of the Mayo score ≥ 2 and > 15 cm of involvement beyond the anal verge

You may not qualify if…

• Women with a positive pregnancy test, who are breastfeeding, or who intend to become pregnant during the course of the study
• Diagnosis of Crohn's disease, microscopic colitis or indeterminate colitis
• Presence of ileostomy or colostomy, or history of prior colon resection
• Patients with planned hospitalization or surgery during the course of the study
• Known allergy to milk proteins, red meat or cornstarch
• Stools positive for enteric infection, including parasitic, or C. difficile toxin within 28 days of screening
• Documented presence of Hetatitis B (HBsAg), Hepatitis C (HCV), or HIV
• Presence of dysplasia of any grade on colonoscopic biopsies
• Treatment for cancer (excluding non-melanomatous cancer of the skin or cervical carcinoma in situ) or lymphoproliferative disorder (including lymphoma) within 5 years
• History of tuberculosis (TB) or Listeria infection, or known exposure to another person with active TB disease within 12 weeks of screening; or history of past or current infection with different opportunistic infections
• History of TNF inhibitor (infliximab, adalimumab or certolizumab pegol) use with primary treatment failure. Secondary treatment failures due to intolerance, allergic reaction, or loss of response will not constitute a basis for exclusion. Oral immunosuppressives, mesalamine, and corticosteroids (up to 20mg of prednisone per day) will be permitted so long as these medications are stable for defined periods of time before study participation commences.

Where it is running

• 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 — Ghent, 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

Full record on ClinicalTrials.gov

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