Evaluation of an Oral Anti-TNF Antibody in Patients With Active Ulcerative Colitis (NCT01759056) | Clinical Trial Compass
CompletedPhase 1
Evaluation of an Oral Anti-TNF Antibody in Patients With Active Ulcerative Colitis
United States33 participantsStarted 2013-02
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 …
What they're measuring
1
Safety and tolerability of AVX-470 over 28 days of treatment