LEO Pharma announced results from the Enstilar phase 3 trial in China in adult patients living with stable plaque psoriasis.

The trial is a phase 3, randomised, investigator-blind, active controlled, parallel group, multicenter trial comparing the efficacy and safety of once daily Enstilar (LEO 90100) and Daivobet ointment for 4 weeks of treatment in adult Chinese subjects with stable plaque psoriasis. A total of 604 patients were recruited across 39 sites in China.¹

The primary objective of the study was to evaluate the efficacy of Enstilar (LEO 90100) compared with Daivobet on severity and extent of stable plaque psoriasis. The secondary objective evaluated treatment safety. Exploratory objectives included evaluating health-related quality of life.¹

The topline results show that Enstilar demonstrated superiority to Daivobet ointment in the primary objective, according to LEO Pharma. 

“With these inspiring clinical results, we are very happy to be able to proceed toward submission of Enstilar to the Chinese authorities, but I am equally pleased that we will now proceed toward hopefully providing Chinese patients with a new treatment option for their psoriasis in addition to the existing portfolio offering from LEO Pharma China,” Byron Yin, General Manager for LEO Pharma in China, said in a company news release.

Following the results, LEO Pharma said it will proceed with preparations to submit Enstilar for approval with the Chinese authorities.

Detailed results from the Enstilar China trial will be submitted for scientific presentation and publication at a later date. For more information on the Enstilar trial (NCT05919082) go to clinicaltrials.gov.