Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00102921
Status:
COMPLETED
Last Update Posted:
2023-08-25
First Post:
2005-02-04
Brief Title:
Safety and Activity Study of an Oral Medication to Treat Moderate to Severe Crohns Disease
Sponsor:
ChemoCentryx
Organization:
ChemoCentryx
Study Overview
Official Title:
Pilot Double-Blind Placebo-Controlled Parallel Group Study of the Safety Clinical Activity of CCX282-B in Patients With Moderate to Severe Crohns Disease
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Crohns Disease in patients who are experiencing an active flare-up of moderate to severe Crohns Disease
Detailed Description:
CCX282-B is being developed as a treatment for inflammatory bowel diseases such as Crohns 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 Crohns Disease and ulcerative colitis
Crohns 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 Crohns 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 Crohns Disease based on changes in the Crohns 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 Crohns Disease In addition blood samples will be collected for evaluation of the population pharmacokinetics of CCX282-B
Crohns 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 Crohns 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 Crohns Disease based on changes in the Crohns 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 Crohns Disease In addition blood samples will be collected for evaluation of the population pharmacokinetics of CCX282-B
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None