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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.
First Received: March 21, 2006   Last Updated: August 25, 2009   History of Changes
Sponsor: ChemoCentryx
Information provided by: ChemoCentryx
ClinicalTrials.gov Identifier: NCT00306215
  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 II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
1: Experimental
Blinded study arm
Drug: CCX282-B
CCX282-B or placebo capsules
2: Experimental
Blinded study arm
Drug: CCX282-B
CCX282-B or placebo capsules
3: Experimental
Blinded study arm
Drug: CCX282-B
CCX282-B or placebo capsules
4: Experimental
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, Inc. ( VP, Medical and Clinical Affairs )
Study ID Numbers: CL004_282
Study First Received: March 21, 2006
Last Updated: August 25, 2009
ClinicalTrials.gov Identifier: NCT00306215     History of Changes
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:
Digestive System Diseases
Gastrointestinal Diseases
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on February 08, 2010