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

NCT01759056 | Completed Phase 1 DMC

• 2 other identifiers: AB11012012-004850-27
• Study Type: interventional
• Target: 33
• Locations: 4 countries
• Sites: 16

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.

Conditions

Ulcerative Colitis

Keywords

Ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of AVX-470 over 28 days of treatment

  Assessments weekly during treatment and 1 week post treatment

  5 weeks

Secondary Outcomes (2)

• Pharmacokinetics (serum, stool and gastrointestinal mucosal tissue levels) of AVX-470

  4 weeks

• Measure the induction of or change in a human anti-bovine immunoglobulin antibody (HABA) response to AVX 470

  4 weeks

Other Outcomes (3)

• Clinical response to AVX 470 in ulcerative colitis, as assessed by the total Mayo score and subscores, after 28 days of treatment compared to Baseline

  4 weeks

• Effect of AVX 470 on endoscopic healing in ulcerative colitis, as assessed by the endoscopic subscore of the total Mayo score and the Ulcerative Colitis Index of Severity (UCEIS), after 28 days of treatment compared to Baseline

  4 weeks

• Evaluate the effects of AVX 470 on biomarkers of ulcerative colitis activity over 28 days of treatment compared to Baseline

  4 weeks

Study Arms (2)

AVX 470

ACTIVE COMPARATOR

AVX 470 0.2 g(Cohort 1), 1.6 g (Cohort 2) and 3.5 g (Cohort 3) will be administered daily for 28 days

Drug: AVX 470

Placebo

PLACEBO COMPARATOR

Placebo will be administered daily for 28 days as a comparator with AVX-470 (all dose groups)

Drug: Placebo

Interventions

AVX 470 DRUG

active comparator

AVX 470

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Avaxia Biologics, Incorporated: lead

Study Sites (16)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

Rocky Mountain Gastroenterology Associates

Lakewood, Colorado, 80215, United States

Location

Shafran Gastroenterology Center

Winter Park, Florida, 327789, United States

Location

Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815, United States

Location

Clinical Research Institute of Michigan

Chesterfield, Michigan, 48047, United States

Location

Center for Digestive and Liver Disease

Mexico, Missouri, 65265, United States

Location

Remington-Davis, Inc.

Columbus, Ohio, 43215, United States

Location

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, 73104, United States

Location

Nashville Medical Research Institute

Nashville, Tennessee, 37205, United States

Location

Gastro-Enterologie

Ghent, 9000, Belgium

Location

Gastro-enterologie

Leuven, 3000, Belgium

Location

The Northern Alberta Clinical Trials and Research Centre

Edmonton, Alberta, T6G 2C8, Canada

Location

Toronto Digestive Disease Associates

Toronto, Ontario, L4L 4Y7, Canada

Location

Semmelweis Egyetem

Budapest, 1083, Hungary

Location

Debreceni Egyetem Orvos- és Egészségtudományi Centrum

Debrecen, 4032, Hungary

Location

Kenézy Kórház Rendelöintézet Egészségügyi Szolgáltató Kft.

Debrecen, 4043, Hungary

Location

Related Publications (2)

• 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.

  PMID: 26822613 DERIVED

• 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.

  PMID: 26802087 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Scott Harris, MD

  Avaxia Biologics, Incorporated

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2012
• First Posted: January 2, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 5, 2014

Record last verified: 2014-02

Locations

BE (2); CA (2); HU (3); US (9)