Clinical trial NCT00102921: Safety and Activity Study of an Oral Medication to Treat Moderate to Severe Crohn's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn Disease
Keywords: Crohn Disease
oral medication
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-02-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Crohn's Disease Activity Index score
measure: Safety (Adverse Events, tolerability)
Secondary outcomes:
measure: Inflammatory Bowel Disease Questionnaire
measure: C-reactive protein
measure: Endoscopic appearance and biopsy of colon and terminal ileum
measure: Markers of leukocyte subsets and activation status
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Golden
country: United States
facility: Rocky Mountain Clincal Research
state: Colorado
city: Littleton
country: United States
facility: Arapahoe Gastroenterology
state: Colorado
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates, LLP
state: New York
city: Raleigh
country: United States
facility: Wake Forest Research
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals of Cleveland, Div of Gastroenterology
state: Ohio
city: Jackson
country: United States
facility: Digestive Disease Clinic
state: Tennessee
city: Nashville
country: United States
facility: Nashville Medical Research Institute
state: Tennessee
city: Salt Lake City
country: United States
facility: Center for Colon Rectal Disease
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Health System, Digestive Health Center of Excellence
state: Virginia
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: