Patients enrolled in ECZTRA 1 and 2 parent trials who continued into ECZTEND have now been treated with tralokinumab for two years
The overall safety profile of tralokinumab was consistent with that observed in the parent trials

BALLERUP, DENMARK, & MADISON, N.J.-- April 26, 2021 -- LEO Pharma A/S, a global leader in medical dermatology, today announced results on the long-term safety and efficacy profile of tralokinumab in adult patients with moderate-to-severe atopic dermatitis. Results were shared as an oral presentation during the American Academy of Dermatology Virtual Meeting Experience (AAD VMX) 2021.

Tralokinumab is a high affinity, human monoclonal antibody that specifically binds to and inhibits the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms.[2,3] It is an investigational therapy in clinical development, and its safety and efficacy are currently being evaluated by regulatory authorities.

The interim analysis at 56 weeks in the ECZTEND trial (NCT03587805) showed tralokinumab 300 mg every other week plus optional topical corticosteroids (TCS) demonstrated long-term improvements in itch, sleep, and in atopic dermatitis signs and symptoms.[1] Patients who had enrolled in pivotal Phase 3 trials ECZTRA 1 and 2 who continued into ECZTEND were on treatment for at least two years.[1]

“Atopic dermatitis is a complex, chronic skin disease that can have devastating and lasting impacts due to the unpredictable nature of the disease. Since patients can live with atopic dermatitis for decades, clinicians are looking for new treatment options that provide predictable long-term results,” said Andrew Blauvelt, MD, MBA, President of Oregon Medical Research Center in Portland, Oregon, and lead investigator for ECZTEND. “We are encouraged by the sustained improvements seen over time in patients treated with tralokinumab in the ECZTEND trial, showing great potential for a promising new treatment option for adults living with uncontrolled moderate-to-severe atopic dermatitis.”

The ongoing 268-week open-label extension trial is investigating the long-term safety and efficacy of tralokinumab 300 mg every other week in patients who previously participated in parent trials ECZTRA 1-8 and TraSki investigator-initiated study.[1] The primary endpoint was defined as the number of adverse events during the treatment period from baseline up to Week 268.[1]

Interim analysis at Week 56 included patients from parent trials ECZTRA 1, 2, ECZTRA 3 and ECZTRA 5. Interim efficacy results at Week 56 were based on the Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and at least a 75% improvement in the Eczema Area and Severity Index score (EASI-75).[