Almirall has announced that its phase 3 studies in atopic dermatitis show that lebrikizumab results in clearer skin for the majority of patients. The drug was used for patients with moderate-to-severe atopic dermatitis as part of Almirall’s Advocate programme.


The announcement was made at the American Academy of Dermatology (AAD) Annual Meeting, revealing that more than 50% of patients with moderate-to-severe AD experienced at least a 75% reduction in disease severity at 16 weeks when receiving lebrikizumab monotherapy in the programme.


The ADvocate programme is made up of two parts, ADvocate 1 and ADvocate 2. The ongoing 52-week global phase 3 studies are randomised, double-blind and placebocontrolled. They are designed to assess lebrikizumab as monotherapy in adult and adolescent patients – aged 12 to less than 18 years old and weighing at least 40kg – with moderate-to-severe atopic dermatitis.


After four weeks, patients receiving lebrikizumab had clearer skin and experienced less itching, and also experienced improved sleep and quality of life. The safety profile of the 16-week period was consistent with prior lebrikizumab studies in atopic dermatitis.


Almirall is expected to submit filings to regulatory bodies worldwide by the end of 2022, once the ADvocate studies have been completed.