Safety and Activity Study of an Oral Medication to Treat Moderate to Severe Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): CCX282-B
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Crohn Disease; oral medication