A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of PF-00547659 in Subjects with Crohn’s Disease
||David Hudesman, MD
frame of study:
||Mount Sinai Beth Israel
name, number and email
Duyang Kim at 212-844-6446
The purpose of the study is to evaluate how effective and safe an investigational drug is in patients with moderate to severe Crohn’s Disease (CD). Participants enrolled in the study will be randomized to three subcutaneous doses (22.5mg, 75mg, and 225mg) of the study drug (PF-00547659), or placebo in a 1:1:1:1 ratio (25% chance of receiving any of the four treatments) for the first 12-weeks. Participants who complete the first 12-weeks will have the option to enter the open label extension study (A7281007) or will enter the 2-year follow-up period for this study. Compensation will be provided and all research procedures, including drug, are covered by the sponsor.
- At least 18 years of age
- Potential subjects have failed or are intolerant to treatment with immunosuppressants or anti-TNF agents.
- Ulcerations on colonoscopy performed during screening (or 8 up to 8 weeks before) as defined by the Simple Endoscopic Score- Crohn’s Disease (SES-CD).
For additional information, or to participate, please contact DuKim@chpnet.org.