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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Avaxia Biologics, Incorporated

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.