Celgene has reported positive results from the RELIEF Phase III clinical trial, which examined OTEZLA (apremilast) for the treatment of patients with active Behçet's disease with oral ulcers.
The findings have demonstrated statistically significant reductions in oral ulcers with apremilast 30mg twice-daily (BID) against placebo through week 12.
The randomised, placebo-controlled, double-blind trial assessed apremilast 30mg BID in 207 patients with active Behçet's disease who were previously treated with at least one topical or systemic medication.
The trial was conducted for a period of 52 weeks at 63 sites throughout ten countries.
Its primary objective was the area under the curve (AUC) for the number of oral ulcers at week 12.
Secondary objectives included change from baseline in pain of oral ulcers, Behçet's syndrome activity score, Behçet's disease current activity index and Behçet's disease quality of life score at week 12.
Celgene inflammation and immunology president Terrie Curran said: “The positive Phase III findings in Behçet's disease reflect the unique aspects of the profile of OTEZLA (apremilast) 30mg across inflammatory-related diseases.
“OTEZLA (apremilast) 30mg has the potential to provide a clinically meaningful new treatment option for patients and doctors and to become the first product indicated specifically for the treatment of active Behçet's disease with oral ulcers.”
According to Celgene, the most common adverse events (AEs) observed in the RELIEF trial were diarrhea, nausea, headache, and upper respiratory tract infection, while the safety profile was found to be consistent with the known safety profile of apremilast.
Celgene intends to submit supplemental new drug applications for apremilast 30mg BID for the treatment of active Behçet's disease with oral ulcers in the US and Japan in the second half of this year.
The company also plans to submit a Type II variation to the marketing authorisation application to the EU next year.