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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014