Celgene International Sàrl, a subsidiary of Celgene Corp. (CELG) presented results from a randomized, placebo-controlled phase II trial in patients with Behçet's disease.
The company announced statistical significance for the primary endpoint of the mean number of oral ulcers at week 12 evaluating the company's oral small-molecule inhibitor of phophodiesterase 4 in patients with Behcet's disease. The complete response rate at week 12 was also statistically significant. Statistically significant and clinically meaningful responses were demonstrated across all secondary endpoints, including all patient-reported outcomes, the company said. Notably, improvement in oral ulcer pain was significantly higher with apremilast than with placebo.
The company said the overall safety and tolerability profile was consistent with previous experience in other apremilast studies with other patient populations.
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