A Study of the Safety and Efficacy of C01275 in Subjects With Crohn's Disease
The purpose of this study is to examine the safety and efficacy of C01275 in subjects with active Crohn's Disease
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Multicenter, Randomized, Phase 2a Study of Human Monoclonal Antibody to IL-12p40 (C01275) in Subjects With Moderately to Severely Active Crohn's Disease|
- The primary endpoint is clinical response at Week 8 for Population 1. Clinical response is defined as a reduction in the CDAI score of = 25% and = 70 points.
- Clinical response following treatment with intravenous or subcutaneous C01275 for Population 1;Clinical response at Week 8 for Population 2;Serum C01275 profile and pharmacokinetic (PK) parameters of a single 5 mg/kg intravenous infusion, at 4 weeks
|Study Start Date:||April 2004|
|Study Completion Date:||October 2006|
|Primary Completion Date:||November 2005 (Final data collection date for primary outcome measure)|
This study is a double-blind, placebo-controlled study. A total of approximately 120 patients will participate in this study in Canada, Belgium, and the United States. There will be 2 separate groups of patients evaluated in this study, Population 1 and Population 2. The 100 patients in this study who are considered Population 1 will be patients who still have active Crohn's disease despite treatment with standard Crohn's disease medications, including 5-ASA medications (for example: Pentasa®, Asacol®), corticosteroids (for example: prednisone) and/or other drugs known to suppress the immune system such as azathioprine, 6-mercaptopurine, methotrexate, infliximab or adalimumab (Humira®). The other 20 patients in the study are considered Population 2. These patients will receive infliximab (Remicade®) administered at the maximum dose described in the approved instructions for using infliximab (Remicade®). Infliximab (Remicade®) is another type of antibody that also works to decrease inflammation and works for many patients with moderate to severe Crohn's disease.
Population 1 will be randomized into 1of 4 treatment groups that receive either by an injection of 100 mg C01275 or placebo at weeks 0, 1, 2, 3, 8, 9, 10 and 11 or an infusion of 5 mg/kg C01275 or placebo at weeks 0 and 8. Subjects in Population 2 receive either an injection of 100 mg C01275 at weeks 0, 1, 2 and 3 or an infusion of 5 mg/kg of C01275 at week 0.