Pilot, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety and Clinical Activity of CCX282-B in Patients with Moderate to Severe Crohn’s Disease

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2005
INTERVENTION: An investigational medication, called CCX282‐B (capsules), compared to placebo CONDITION: Crohn's Disease ; Digestive System ; Crohn's disease PRIMARY OUTCOME: 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 OUTCOME: 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. INCLUSION CRITERIA: 1. Diagnosis of moderate to severe Crohn's Disease in small intestine; disease must be active at the time of study entry 2. Use of adequate and approved methods of birth control throughout the study period 3. Willing and able to sign an informed consent
Epistemonikos ID: a467795226911a09177fbf46c3e6c6f4441c4372
First added on: Aug 21, 2024