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

NCT ID: NCT00102921

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2005-12-31

Brief Summary

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.

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.

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Conditions

Crohn Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

CCX282-B

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Rocky Mountain Clincal Research

Golden, Colorado, United States

Arapahoe Gastroenterology

Littleton, Colorado, United States

Atlanta Gastroenterology Associates

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Comprehensive Clinical Research

Berlin, New Jersey, United States

Long Island Clinical Research Associates, LLP

Great Neck, New York, United States

Wake Forest Research

Raleigh, North Carolina, United States

University Hospitals of Cleveland, Div of Gastroenterology

Cleveland, Ohio, United States

Digestive Disease Clinic

Jackson, Tennessee, United States

Nashville Medical Research Institute

Nashville, Tennessee, United States

Center for Colon Rectal Disease

Salt Lake City, Utah, United States

University of Virginia Health System, Digestive Health Center of Excellence

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

CL003_282

Identifier Type: -

Identifier Source: org_study_id