Our PROTECT-1 Clinical Trial in Crohn's Disease

The Prospective Randomized Oral Therapy Evaluation in Crohn's disease Trial (PROTECT-1) is designed to demonstrate Traficet-EN™'s efficacy as an oral treatment capable of inducing clinical response or remission among patients with moderate-to-severe Crohn's disease. This trial is being conducted in 17 countries around the world at more than 100 study centers.

PROTECT-1 is a double-blind, randomized and placebo-controlled study. The study will enroll over 400 subjects and will be powered to provide statistically significant evidence of efficacy.

The PROTECT-1 clinical trial includes four separate study periods:

1. A 12-week induction period during which all subjects receive either placebo, 250 mg once daily, 500 mg once daily or 250 mg twice daily of Traficet-EN.
2. A four-week active treatment period during which all subjects receive Traficet-EN 250 mg twice daily.
3. A 36-week maintenance period during which all patients with a 70-point-or-greater drop in Crohn's Disease Activity Index (CDAI) scores at the end of the active treatment period relative to their baseline entry level criteria are re-randomized to either Traficet-EN 250 mg twice daily or placebo.
4. A four-week follow-up period during which all subjects are followed for safety while off the drug.

The primary efficacy endpoint of the first study period, or the induction phase of the study, is the attainment of a clinical response (defined as at least a 70-point decrease in the CDAI relative to placebo) at Day 57 of the induction phase. Remicade® and Humira® were approved to treat Crohn's disease based on trials of this size with similar protocols. Today, most major studies in Crohn's disease use the CDAI in order to define response or remission of disease.

The first study period also includes an evaluation of the effect of Traficet-EN on microscopic features of the small and large bowel surface tissue, endoscopic appearance of the bowel surface tissue using the Crohn's Disease Endoscopic Index of Severity, or CDEIS, health-related quality of life using a health questionnaire, and serum C-reactive protein, or CRP, concentrations. CRP is a non-specific marker of the level of inflammation.

The primary endpoint of the third study period, or the maintenance period, is to determine the effect of Traficet-EN compared to placebo on maintenance of response as measured by CDAI over a 36-week period. The third study period also includes an evaluation of the effect of Traficet-EN on health-related quality of life using a health questionnaire, serum CRP concentrations and the use of glucocorticosteroid treatment.

We will also be evaluating the safety and tolerability of the three dose levels of Traficet-EN (250 mg and 500 mg once daily, and 250 mg twice daily) administered orally for up to 12 consecutive weeks in the induction period for the treatment of subjects with moderate-to-severe Crohn's disease, and of one dose level of Traficet-EN (250 mg twice daily) administered orally for up to one year. Blood samples will be collected to determine the blood levels of Traficet-EN in these patients.

We are enrolling patients presenting with an active flare and CDAI scores of between 250 to 450 and CRP levels of at least 7.5 mg/L. This is the same patient population in which we observed clinical activity in our 28-day Phase II clinical trial. These criteria are intended to ensure that we enroll Crohn's disease patients who are in active flare, as opposed to patients with unrelated gastrointestinal diseases, the effects of which might result in a significantly increased CDAI score. Moreover, meta-analyses of previous Crohn's disease trials have shown that these criteria may reduce the placebo effect previously observed in certain other Crohn's disease trials.

If you or someone you know is interested in participating in this clinical trial, a list of international study sites with contact information is available at www.clinicaltrials.gov using the search term: CCX282. Further information is also available at www.protect-trial.com. Patients and their physicians may also contact us at PROTECT-1@ChemoCentryx.com and one of our clinical specialists will assist you with any questions regarding the PROTECT-1 study.

^ Return to Top