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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ChemoCentryx
ClinicalTrials.gov Identifier:
NCT00306215
First received: March 21, 2006
Last updated: February 8, 2012
Last verified: February 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Crohn's Disease
 Drug: CCX282-B
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Further study details as provided by ChemoCentryx:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 436
Study Start Date: March 2006
Study Completion Date: June 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00306215

  Show 112 Study Locations
Sponsors and Collaborators
ChemoCentryx
Investigators
Study Director: Pirow Bekker, MD, PhD ChemoCentryx, Inc
  More Information

No publications provided

Responsible Party: ChemoCentryx
ClinicalTrials.gov Identifier: NCT00306215     History of Changes
Other Study ID Numbers: CL004_282
Study First Received: March 21, 2006
Last Updated: February 8, 2012
Health Authority: Austria: Agency for Health and Food Safety
Brazil: National Health Surveillance Agency
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Israel: Israeli Health Ministry Pharmaceutical Administration
Netherlands: Medicines Evaluation Board (MEB)
Poland: Ministry of Health
South Africa: Medicines Control Council
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by ChemoCentryx:
double-blind
placebo-controlled
multicenter
efficacy
safety

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on June 18, 2013