Biopharmaceutical firm Dermira has commenced a Phase III programme comprising two identical trials of lebrikizumab for the treatment of moderate-to-severe atopic dermatitis.
Dosing has started in a trial designed to assess the drug’s safety and efficacy in adult and adolescent patients aged 12 and above.
Lebrikizumab is an investigational, monoclonal antibody that binds to IL-13 to prevent the formation of the IL-13Rα1/IL-4Rα heterodimer complex and its signalling in order to inhibit IL-13’s biological effects.
IL-13 is believed to play a key role in the atopic dermatitis pathophysiology by inducing type 2 inflammation and mediating its effects on tissue.
Dermira chairman and CEO Tom Wiggans said: “The positive results of our Phase IIb dose-ranging study suggest specifically targeting IL-13 with lebrikizumab has the potential to deliver a best-in-disease therapy for people living with moderate-to-severe atopic dermatitis.
“Our Phase III clinical programme is designed to confirm those findings and hopefully bring an important new treatment option to the millions of people living with this chronic and often debilitating disease.”
The two randomised, double-blind, placebo-controlled, parallel-group studies under the Phase III programme are set to enrol around 800 patients at 200 sites in the US, Europe and Asia.
During the trials, 250mg subcutaneous lebrikizumab administered every two weeks after a 500mg loading dose at baseline and week two will be compared to placebo for 16 weeks.
After the completion of the 16-week induction period, participants achieving a response will be re-randomised to receive either 250mg lebrikizumab every two/four weeks or placebo every two weeks.
Subjects without a response at week 16 will be administered with the 250mg dose as an open-label treatment every two weeks until week 52.
Data from the trial is expected to be reported in the first half of 2021.
The company also intends to further study the drug in combination with topical corticosteroids in a separate trial under the Phase III programme.