Almirall announced the publication of Week 16 and Week 52 results of ADvocate1 and ADvocate2 by the New England Journal of Medicine (NEJM) and the British Journal of Dermatology (BJD), respectively. ADvocate1 and ADvocate2 are two identical 52-week randomized, double-blind, placebo-controlled, parallel-group, Phase 3 studies (NCT04146363 and NCT04178967), evaluating lebrikizumab as monotherapy in adult and adolescent patients with moderate-to-severe atopic dermatitis.

“People living with moderate to severe atopic dermatitis need more treatment options that are tailored to their unique needs and preferences,” Jonathan Silverberg, M.D., professor of Dermatology at George Washington University School of Medicine & Health Sciences and co-investigator of the studies, said in a company news release. “In clinical trials, patients experienced significantly clearer skin and less interference with sleep due to itch when taking lebrikizumab compared to placebo. These results are very promising for patients with atopic dermatitis.”

The Phase 3 studies, which included 851 patients, evaluated the efficacy and safety of monotherapy with subcutaneous lebrikizumab 250 mg (with a 500 mg loading dose given at baseline and Week 2) in adult and adolescent patients with moderate-to-severe AD. Patients were randomly assigned in a 2:1 ratio to lebrikizumab 250 mg or placebo every 2 weeks in the 16-week induction period.

Both Phase 3 studies met the co-primary endpoints, which were IGA 0/1 with a reduction of at least two points from baseline at Week 16, and the proportion of patients achieving EASI-75 or greater change from baseline at Week 16. For patients who achieved a clinical response at Week 16 through 1 year of treatment, lebrikizumab maintained robust and durable efficacy in skin clearance and itch. The results delivered were similar when dosed once every 4 weeks or once every 2 weeks.

“We are delighted by the publication of the Phase 3 data in the NEJM and BJD respectively, highly regarded and rigorously peer-reviewed journals. The published clinical trial data support the positive results we have reported previously on the potential efficacy of lebrikizumab in moderate-to-severe AD and underscore our commitment to people living with AD,” said Karl Ziegelbauer, PhD, Almirall’s Chief Scientific Officer. “Awaiting approval in Europe later this year, we are still working toward the market launch of this treatment, convinced of its potential to become a best-in-class treatment for atopic dermatitis.”

Recently, the peer-reviewed medical journal JAMA Dermatology published the results of the Phase 3 clinical trial Adhere (ClinicalTrials.gov Identifier: NCT04250337) evaluating the efficacy and safety of lebrikizumab in combination with topical corticosteroid (TCS) therapy in adolescents and adults with moderate-to-severe AD. In this randomized Phase 3 clinical trial, lebrikizumab in combination with TCS was associated with improved outcomes compared with TCS alone, and safety was consistent with previously reported AD trials.

Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including AD, in Europe. Eli Lilly has exclusive rights for the development and commercialization of lebrikizumab in the United States and the rest of the world, not including Europe.