Dose Ranging Study Comparing the Efficacy, Safety and Pharmacokinetics of Intravenous Infusions of ABT-874 vs Placebo in Subjects With Active Crohn's Disease
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A Phase 2B, Multi-Center, Randomized, Double-blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety and Pharmacokinetics of Intravenous Infusions of ABT-874 vs. Placebo in Subjects With Moderately to Severely Active Crohn's Disease.
Study Start Date :
Actual Primary Completion Date :
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Ages Eligible for Study:
18 Years to 74 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Diagnosis of Crohn's disease for greater than 4 months confirmed by endoscopy or radiologic evaluation.
CDAI score of >= 220 and <= 450 at Week 0.
Males and females >= 18 years and < 75 years of age at the Screening visit.
Judged to be in generally good health as determined by the Investigator.
Current diagnosis of the colitis other than Crohn's disease.
Symptomatic known strictures.
Surgical bowel resections within the past 6 months or is planning any resection at any time point while enrolled in the study.
Ostomy or ileoanal pouch. (Subjects with a previous ileo-rectal anastomosis are not excluded).
Short bowel syndrome as determined by the investigator.
Infection or risk factors for severe infections.
Females who are pregnant or considering becoming pregnant during the study, or breast-feeding.