ChemoCentryx completes enrollment for Phase II/III Crohn’s disease trial

This clinical trial comprises three discrete phases which allows for evaluation of efficacy and safety of Traficet-EN in inducing a clinical response or remission, as well as maintaining response/remission in Crohn’s disease over a combined total of 12 months. The company is on track to report data from the induction phase of this trial in the fourth quarter of 2008.

Protect-1 is a randomized, placebo-controlled, double-blind study that includes a 12-week ‘induction period’, during which patients with moderate-to-severe Crohn’s disease will receive either Traficet-EN or a placebo in order to evaluate the drug’s ability to induce a clinical response or remission.

The induction phase of the study is followed by a four-week, open label ‘active period’, during which all subjects receive Traficet-EN. Patients who achieve a pre-specified reduction in disease severity are re-randomized to active drug or placebo for an additional 36-week ‘maintenance period’, thereby permitting an evaluation of the drug’s ability to maintain a treatment response.

The primary efficacy endpoint in the induction Phase of the study is the attainment of a clinical response defined as a decrease from baseline in the Crohn’s disease activity index score of at least 70 points.

In a separate clinical trial, Traficet-EN is also being evaluated for patients with celiac disease, a sensitivity to gluten and gluten derivatives in which digestive tract T cells are thought to play an important role.