Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients

Status:	Completed
Conditions:	Colitis, Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	18 - 65
Updated:	3/30/2013
Start Date:	March 2011
End Date:	April 2013
Contact:	Pfizer CT.gov Call Center
Phone:	1-800-718-1021

A Phase 2A, Randomized, Double-Blind, Sponsor Unblinded, Placebo-Controlled, Multiple Dose Study To Evaluate The Pharmacodynamics, Pharmacokinetics And Safety Of Anrukinzumab In Patients With Active Ulcerative Colitis

This study represents the first investigation of anrukinzumab in patients with active
ulcerative colitis (UC) and will evaluate proof of mechanism by changes in the mechanism
based biomarker (YKL 40) and pharmacodynamic biomarkers (fecal calprotectin, lactoferrin and
hs-CRP). It will provide further assessment of the safety, tolerability, and
pharmacokinetics (PK) by administration of multiple intravenous (IV) doses of anrukinzumab.

Inclusion Criteria:

- Male or Female, Age >=18 and <=65 years

- Active ulcerative colitis (UC) beyond the rectum based upon Mayo Score

- women of childbearing potential with highly effective method of contraception

Exclusion Criteria:

- Indeterminate disease status, Crohn's disease, ischemic colitis, positive HIV,
positive or history of tuberculosis infection, active enteric infections, transplant
organ recipient, concomitant steroids, immunosuppressives or anti-TNFs.

We found this trial at

sites

Pfizer Investigational Site

Bridgeport, Connecticut 06606

135

from 02139

Bridgeport, CT