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A Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00306215
Recruitment Status : Completed
First Posted : March 23, 2006
Last Update Posted : February 9, 2012
Sponsor:
Information provided by (Responsible Party):
ChemoCentryx

Study Description
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Brief Summary:
The purpose of this study is to determine whether CCX282-B is effective in treating patients with moderate to severe Crohn's Disease.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: CCX282-B Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 436 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multinational, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's Disease
Study Start Date : March 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Blinded study arm
 Drug: CCX282-B
CCX282-B or placebo capsules
Experimental: 2
Blinded study arm
 Drug: CCX282-B
CCX282-B or placebo capsules
Experimental: 3
Blinded study arm
 Drug: CCX282-B
CCX282-B or placebo capsules
Experimental: 4
Blinded study arm
 Drug: CCX282-B
CCX282-B or placebo capsules


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of subjects achieving a clinical response (defined as a decrease from baseline in Crohn's Disease Activity Index [CDAI] score of at least 70) on Day 57 [ Time Frame: Day 57 ]

Secondary Outcome Measures :
  1. Percentage of subjects achieving clinical remission (defined as a Crohn's Disease Activity Index [CDAI] score less than or equal to 150) on Day 57 [ Time Frame: Day 57 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • moderate to severe Crohn's Disease
  • CDAI 250-450
  • CRP >7.5
  • signed written informed consent

Key Exclusion Criteria:

  • > 100 cm of small bowel resected
  • ileostomy, colostomy or rectal pouch
  • diagnosis of ulcerative colitis or indeterminate colitis
  • evidence of short bowel syndrome requiring enteral or parenteral supplementation or total parenteral nutrition
  • hepatitis B, C or HIV infection
  • history of infection requiring IV antibiotics
  • serious or GI infection in the previous 12 weeks
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00306215


Locations
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Sponsors and Collaborators
ChemoCentryx
Investigators
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Study Director: Pirow Bekker, MD, PhD ChemoCentryx, Inc
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: ChemoCentryx
ClinicalTrials.gov Identifier: NCT00306215    
Other Study ID Numbers: CL004_282
First Posted: March 23, 2006    Key Record Dates
Last Update Posted: February 9, 2012
Last Verified: February 2012
Keywords provided by ChemoCentryx:
double-blind
placebo-controlled
multicenter
efficacy
safety
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases