Clinical trial · Interventional
Evaluation of an Oral Anti-TNF Antibody in Patients With Active Ulcerative Colitis
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
NCT01759056CI-TRIAL-00013950completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ulcerative Colitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AVX 470 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- AVX 470
- description
- 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
- interventionNames
- Drug: AVX 470
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo will be administered daily for 28 days as a comparator with AVX-470 (all dose groups)
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Safety and tolerability of AVX-470 over 28 days of treatment
- timeFrame
- 5 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDHarris 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
- DERIVEDHartman 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