Safety and Activity Study of an Oral Medication to Treat Moderate to Severe Crohn’s Disease

This study has been completed.
Sponsor:
Information provided by:
ChemoCentryx
ClinicalTrials.gov Identifier:
NCT00102921
First received: February 4, 2005
Last updated: March 12, 2006
Last verified: March 2006
  Purpose

The purpose of this research study is to investigate the effects of an investigational medication, called CCX282-B, on safety and on the some of the symptoms of Crohn’s Disease in patients who are experiencing an active flare-up of moderate to severe Crohn’s Disease.


Condition Intervention Phase
Crohn 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
Primary Purpose: Treatment
Official Title: Pilot, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety Clinical Activity of CCX282-B in Patients With Moderate to Severe Crohn’s Disease

Resource links provided by NLM:


Further study details as provided by ChemoCentryx:

Primary Outcome Measures:
  • Crohn’s Disease Activity Index score
  • Safety (Adverse Events, tolerability)

Secondary Outcome Measures:
  • Inflammatory Bowel Disease Questionnaire
  • C-reactive protein
  • Endoscopic appearance and biopsy of colon and terminal ileum
  • Markers of leukocyte subsets and activation status

Estimated Enrollment: 70
Study Start Date: August 2004
Estimated Study Completion Date: December 2005
Detailed Description:

CCX282-B is being developed as a treatment for inflammatory bowel diseases such as Crohn’s Disease. CCX282-B is a highly potent, orally active, chemokine receptor antagonist whose single target is the G-protein coupled receptor CCR9. The CCR9 receptor is expressed by most T-cells in the thymus as well as in the intestine, and by a small population of T-cells in the peripheral blood. In humans, the CCR9 receptor is implicated in Crohn’s Disease and ulcerative colitis.

Crohn’s Disease is an autoimmune disease involving the entire length of the gastrointestinal tract, but with most manifestations in the terminal small intestine and colon. This condition is characterized by mucosal ulcerations that penetrate deeply into the bowel wall. Sometimes the ulcerative lesions completely penetrate the bowel wall, leading to fistula formation and infectious complications requiring surgical intervention. Patients experience considerable lifestyle disruption and disability from this disease, including diarrhea, abdominal pain, malnutrition, anemia, and repetitive surgeries to remove disease-affected gastrointestinal segments.

ChemoCentryx Protocol CL003_282 is a double-blind, placebo-controlled, parallel group, two stratum, Phase 2A pilot study of the safety, tolerability, immunologic and clinical activity, and population pharmacokinetics of a single dose level of CCX282-B administered daily for four consecutive weeks to patients with active, moderate to severe Crohn’s Disease. The primary immunologic and clinical activity objective of this study is to provide pilot information regarding the immunologic and clinical activity of daily oral doses of CCX282-B in the treatment of moderate to severe Crohn’s Disease, based on changes in the Crohn’s Disease Activity Index (CDAI). Secondary immunologic and clinical activity objectives include evaluation of the effect of CCX282-B on the Inflammatory Bowel Disease Questionnaire (IBDQ) instrument, C-reactive protein (CRP), the endoscopic appearance and biopsy of the colon and terminal ileum, and markers of leukocyte subsets and activation status. The primary safety objective of this study is to evaluate the safety and tolerability of oral doses of CCX282-B in patients with moderate to severe Crohn’s Disease. In addition, blood samples will be collected for evaluation of the population pharmacokinetics of CCX282-B.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of moderate to severe Crohn's Disease in small intestine; disease must be active at the time of study entry
  • Use of adequate and approved methods of birth control throughout the study period
  • Willing and able to sign an informed consent

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV; the virus that causes AIDS)
  • Abuse of alcohol or of illegal drugs
  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: NCT00102921

Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Colorado
Rocky Mountain Clincal Research
Golden, Colorado, United States, 80104
Arapahoe Gastroenterology
Littleton, Colorado, United States, 80120
United States, Georgia
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30342
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States
United States, New Jersey
Comprehensive Clinical Research
Berlin, New Jersey, United States, 08009
United States, New York
Long Island Clinical Research Associates, LLP
Great Neck, New York, United States, 11021
United States, North Carolina
Wake Forest Research
Raleigh, North Carolina, United States, 27612
United States, Ohio
University Hospitals of Cleveland, Div of Gastroenterology
Cleveland, Ohio, United States, 44106-5066
United States, Tennessee
Digestive Disease Clinic
Jackson, Tennessee, United States, 38305
Nashville Medical Research Institute
Nashville, Tennessee, United States, 37205
United States, Utah
Center for Colon Rectal Disease
Salt Lake City, Utah, United States, 84124
United States, Virginia
University of Virginia Health System, Digestive Health Center of Excellence
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
ChemoCentryx
Investigators
Study Director: JJ Kim Wright, PhD ChemoCentryx, Inc
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00102921     History of Changes
Other Study ID Numbers: CL003_282
Study First Received: February 4, 2005
Last Updated: March 12, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by ChemoCentryx:
Crohn Disease
oral medication

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

ClinicalTrials.gov processed this record on August 19, 2014