Overview

Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease

Status:
Completed
Trial end date:
2015-10-09
Target enrollment:
0
Participant gender:
All
Summary
Adults with Crohn's disease that is clinically active despite conventional treatment will be eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental drug) or placebo (inactive drug). Disease activity will be measured every two weeks.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Shire
Criteria
Inclusion Criteria:

- Subjects must have failed or are intolerant to anti-TNFs and/or immunosuppressants
(AZA, 6-MP, and/or MTX).

- hsCRP greater than 3mg/L

- Ulcerations demonstrated by colonoscopy performed during screening or 8 weeks prior to
screening

Exclusion Criteria:

- Pregnant or breast feeding

- Short bowel syndrome due to multiple small bowel resections

- Presence of a stoma