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

Sponsor:	ChemoCentryx
Information provided by (Responsible Party):	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:	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:

Genetics Home Reference related topics: Crohn disease

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

Criteria

Key Inclusion Criteria:

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

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 February 09, 2012