Dose Ranging Study Comparing the Efficacy, Safety and Pharmacokinetics of Intravenous Infusions of ABT-874 vs Placebo in Subjects With Active Crohn's Disease

Abbott

Status and phase: Terminated; Phase 2

Conditions: Crohn's Disease

Treatments: Biological: Placebo; Biological: ABT-874

Study type: Interventional

Funder types: Industry

Identifiers

NCT00562887

2008-004919-36 (Registry Identifier)

M10-222

Details and patient eligibility

About

To compare the efficacy, safety and pharmacokinetics of ABT-874 to placebo in subjects who have moderately to severely active Crohn's Disease.

Enrollment: 246 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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246 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Biological: Placebo

400 mg

Experimental group

Treatment:

Biological: ABT-874

Biological: ABT-874

700mg

Experimental group

Treatment:

Biological: ABT-874

Biological: ABT-874