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 and maintaining clinical response or remission among patients with moderate-to-severe Crohn's disease. This trial has been 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 has enrolled 436 subjects and was 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 received either placebo, 250 mg once daily, 500 mg once daily or 250 mg twice daily of Traficet-EN.
2. A 4-week active treatment period during which all subjects received Traficet-EN 250 mg twice daily.
3. A 36-week maintenance period during which all subjects 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 were re-randomized to either Traficet-EN 250 mg twice daily or placebo.
4. A 4-week follow-up period during which all subjects were followed for safety while off the drug.

Overall, Traficet-EN™ (CCX282-B) in patients with moderate-to-severe Crohn's disease demonstrated evidence of efficacy in both the induction of treatment response as well as the maintenance of remission based on results from the PROTECT-1 study. Furthermore, Traficet-EN was shown to be well tolerated and safe over the one-year course of this study.

More specifically, data reported from the induction period of the PROTECT-1 trial showed that the 500 mg once-daily dose (QD) of Traficet-EN in patients with small bowel and/or colonic Crohn's disease was consistently superior to placebo across multiple efficacy endpoints. At week 12, the CDAI ≥ 70-point response was 61 percent in the 500 mg QD group versus 47 percent for placebo (p=0.039). Similarly, the CDAI ≥ 100-point response was 55 percent in this group versus 40 percent for placebo (p=0.029). In addition, colonoscopic evidence of improvement based on the Crohn's Disease Endoscopic Index of Severity (CDEIS) was observed in the 500 mg QD group compared to placebo (CDEIS decrease of -8.4 vs. -1.1 for placebo, p=0.049). C-reactive protein (CRP) results confirmed the effect of 500 mg QD Traficet-EN.

Furthermore, data from the maintenance period of PROTECT-1 showed that Traficet-EN treatment was able to maintain the clinical remission rate at about 50%, whereas the remission rate dropped progressively in the placebo group over the course of the maintenance period. At week 36, 47% of patients in the Traficet-EN group were in remission compared to 31% in placebo (p=0.011).

Finally, safety and tolerability data of Traficet-EN administered orally for up to 12 consecutive months to subjects in the PROTECT-1 trial showed that Traficet-EN was safe and well tolerated, with no evidence of immune system compromise.

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