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

Crohn Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00102921
• Other study ID #: CL003_282
• Status: Completed
• Phase: Phase 2
• Start date: August 2004
• Est. completion date: December 2005

Study information

• Verified date: August 2023
• Source: ChemoCentryx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• CCX282-B

Locations

Country	Name	City	State
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	Comprehensive Clinical Research	Berlin	New Jersey
United States	University of Virginia Health System, Digestive Health Center of Excellence	Charlottesville	Virginia
United States	University of Chicago	Chicago	Illinois
United States	University Hospitals of Cleveland, Div of Gastroenterology	Cleveland	Ohio
United States	Rocky Mountain Clincal Research	Golden	Colorado
United States	Long Island Clinical Research Associates, LLP	Great Neck	New York
United States	Digestive Disease Clinic	Jackson	Tennessee
United States	Arapahoe Gastroenterology	Littleton	Colorado
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Nashville Medical Research Institute	Nashville	Tennessee
United States	Wake Forest Research	Raleigh	North Carolina
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	Center for Colon Rectal Disease	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
ChemoCentryx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Crohn's Disease Activity Index score
Primary	Safety (Adverse Events, tolerability)
Secondary	Inflammatory Bowel Disease Questionnaire
Secondary	C-reactive protein
Secondary	Endoscopic appearance and biopsy of colon and terminal ileum
Secondary	Markers of leukocyte subsets and activation status