Safety and Activity Study of an Oral Medication to Treat Moderate to Severe Crohn's Disease
Pilot, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety Clinical Activity of CCX282-B in Patients With Moderate to Severe Crohn's Disease
1 other identifier
interventional
70
1 country
14
Brief Summary
The purpose of this research study is to investigate the effects of an investigational medication, called CCX282-B, on safety and on the some of the symptoms of Crohn's Disease in patients who are experiencing an active flare-up of moderate to severe Crohn's Disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2004
Shorter than P25 for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 4, 2005
CompletedFirst Posted
Study publicly available on registry
February 7, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedMarch 6, 2025
March 1, 2025
February 4, 2005
March 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Crohn's Disease Activity Index score
Safety (Adverse Events, tolerability)
Secondary Outcomes (4)
Inflammatory Bowel Disease Questionnaire
C-reactive protein
Endoscopic appearance and biopsy of colon and terminal ileum
Markers of leukocyte subsets and activation status
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of moderate to severe Crohn's Disease in small intestine; disease must be active at the time of study entry
- Use of adequate and approved methods of birth control throughout the study period
- Willing and able to sign an informed consent
You may not qualify if:
- Pregnant or breastfeeding
- Infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV; the virus that causes AIDS)
- Abuse of alcohol or of illegal drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (14)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Rocky Mountain Clincal Research
Golden, Colorado, 80104, United States
Arapahoe Gastroenterology
Littleton, Colorado, 80120, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342, United States
University of Chicago
Chicago, Illinois, 60637, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
Long Island Clinical Research Associates, LLP
Great Neck, New York, 11021, United States
Wake Forest Research
Raleigh, North Carolina, 27612, United States
University Hospitals of Cleveland, Div of Gastroenterology
Cleveland, Ohio, 44106-5066, United States
Digestive Disease Clinic
Jackson, Tennessee, 38305, United States
Nashville Medical Research Institute
Nashville, Tennessee, 37205, United States
Center for Colon Rectal Disease
Salt Lake City, Utah, 84124, United States
University of Virginia Health System, Digestive Health Center of Excellence
Charlottesville, Virginia, 22908, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2005
First Posted
February 7, 2005
Study Start
August 1, 2004
Study Completion
December 1, 2005
Last Updated
March 6, 2025
Record last verified: 2025-03