Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Colitis, Ulcerative

In brief

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.

Key facts

Study ID

NCT01284062

Run by

Pfizer

People needed

84

Starts

2011-03-01

Expected to finish

2013-04-01

Last updated by the study team

2014-11-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• UAB Hospital — Birmingham, Alabama, United States
• UAB Hospital Department of Pharmacy — Birmingham, Alabama, United States
• Administrative Offices — Birmingham, Alabama, United States
• UAB ACIP — Birmingham, Alabama, United States
• Arizona Surgical Center — Phoenix, Arizona, United States
• Dedicated Phase I, Inc. — Phoenix, Arizona, United States
• AGMG Endoscopy Center — Anaheim, California, United States
• Anaheim Clinical Trials, LLC — Anaheim, California, United States
• West Coast Radiology Center — Santa Ana, California, United States
• Endoscopy Center of Connecticut, LLC — Hamden, Connecticut, United States
• Gastroenterology Center of Connecticut, PC — Hamden, Connecticut, United States
• Medical Research Center of Connecticut, LLC — Hamden, Connecticut, United States
• International Clinical Research - US, LLC — Sanford, Florida, United States
• Gastrointestinal Specialists of Georgia, PC — Marietta, Georgia, United States
• GI Diagnostics — Marietta, Georgia, United States
• Gastrointestinal Associates, PA — Jackson, Mississippi, United States
• Gastrointestional Associates, PA — Jackson, Mississippi, United States
• St. Dominic Hospital — Jackson, Mississippi, United States
• Digestive Health Specialists, PA — Tupelo, Mississippi, United States
• North Mississippi Medical Center — Tupelo, Mississippi, United States
• Premier Medical Group of the Hudson Valley — Poughkeepsie, New York, United States
• Piedmont Gastroenterology Specialists — Winston-Salem, North Carolina, United States
• PMG Research of Winston-Salem — Winston-Salem, North Carolina, United States
• University Hospitals Case Medical Center - Division of Gastroenterology and Liver Disease — Cleveland, Ohio, United States
• The Kirkland Clinic — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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