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

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.

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00562887

Enrollment

246

Registered

2007-11-26

Start date

2007-11-30

Completion date

Unknown

Last updated

2011-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Keywords

Crohn's Disease

Brief summary

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

Interventions

BIOLOGICALPlacebo

every 4 weeks, IV

BIOLOGICALABT-874

400 mg IV every 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 74 Years

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.

Design outcomes

Primary

Measure	Time frame
Proportion of subjects achieving clinical remission, defined as CDAI score of <150 points	Week 6

Secondary

Measure	Time frame
Patient reported outcomes, clinical response indicators, safety parameters	Weeks 12 and 24

Countries

Australia, Austria, Belgium, Canada, Denmark, Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026