LEO Pharma Presents New Adtralza® (tralokinumab) Data in Adolescent Population from ECZTRA 6 and ECZTEND Trials at ISAD 2023 Meeting

BALLERUP, Denmark, September 8 – LEO Pharma A/S presented new clinical data from the ECZTRA 6 and ECZTEND trials of Adtralza^® (tralokinumab) in adolescent patients aged 12 to 17 years with moderate-to-severe AD. The data was presented at the International Society of Atopic Dermatitis (ISAD) 2023 Meeting.

Post hoc analysis from the Phase 3 ECZTRA 6 trial demonstrated progressive improvements in control in adolescents with AD treated with a subcutaneous injection of 300 mg Adtralza every two weeks. Greater proportions of patients treated with 300 mg Adtralza met primary and secondary endpoints compared to placebo, including statistically and clinically significant improvements in the Eczema Area and Severity Index (EASI) and patient-reported outcomes (PROs). These improvements were sustained across all endpoints through Week 52. The safety profile was also consistent with prolonged treatment following Week 16.¹

Data from the ongoing open-label ECZTEND study, which included 126 adolescents continuing treatment after the completion of the ECZTRA 6 trial, demonstrated that Adtralza continues to provide disease control for up to two years in adolescents with moderate-to-severe AD. Sustained efficacy after two years was demonstrated across several endpoints, including at least a 75% EASI reduction (EASI-75) in 84.4% of adolescent participants, and an EASI-90 of 69.7%. The safety profile remained consistent with that of ECZTRA 6.²

“We are incredibly encouraged by this additional analysis, which further reinforces our evidence of sustained improvement in atopic dermatitis symptoms among adolescents when treated with Adtralza,” said Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma. “This debilitating disease can have a particularly strong impact on young people, who often feel socially isolated because of their skin condition.”

About atopic dermatitis

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.³ Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.⁴ Type 2 cytokines, including IL-13, play an important role in the key aspects of atopic dermatitis pathophysiology.^4,5

About Adtralza^® (tralokinumab)

Adtralza^® (tralokinumab), which is marketed under the tradename Adbry^® in the U.S., is a high-affinity fully human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms.^4,5 Adtralza specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).⁶

Adtralza is approved for the treatment of moderate-to-severe AD in adult and adolescent patients 12 years and older who are candidates for systemic therapy in the European Union, Canada, Great Britain, the United Arab Emirates, and South Korea. Adtralza is approved for use in adults with moderate-to-severe AD in the U.S., Switzerland, Saudi Arabia, and Japan.

About the ECZTRA 6 Trial   

ECZTRA 6 is a randomized, double-blind, placebo-controlled, parallel-group, multinational 52-week trial, with 289 patients aged 12 to 17 (195 Adtralza patients and 94 placebo patients), evaluating the efficacy and safety of Adtralza (150 mg or 300 mg) monotherapy compared to placebo in adolescents with moderate-to-severe atopic dermatitis who were candidates for systemic therapy.⁷ 

About the ECZTEND - Long-Term Extension (LTE) Trial 

ECZTEND (Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials) is an ongoing Phase 3, long-term, five-year, open-label, single-arm extension trial to evaluate the safety and efficacy of Adtralza in patients with atopic dermatitis who participated in the previous Adtralza monotherapy trials (ECZTRA 1 and ECZTRA 2), the combination therapy Adtralza plus TCS trial (ECZTRA 3), the Drug-drug interaction (DDI) trial (ECZTRA 4), the vaccine trial (ECZTRA 5), the adolescent trial (ECZTRA 6), the oral cyclosporine A trial (ECZTRA 7), the combination therapy Adbry plus TCS trial in Japanese subjects (ECZTRA 8), and the Adtralza monotherapy skin barrier function trial (TraSki). Patients were permitted to enter ECZTEND after completion of the parent trial regardless of their treatment response or whether they were treated with Adtralza or placebo.^2,8,9 

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References

1. Wollenberg A, et al. Progressive and sustained disease control in patients with atopic dermatitis (AD) aged 12–17 years treated with tralokinumab for 52 weeks. Presented at the International Society of Atopic Dermatitis (ISAD) 2023 Meeting. Gdansk, Poland. 31 August – 02 September.
2. Wollenberg A, et al. Long-term efficacy of tralokinumab in adolescents with moderate-to-severe atopic dermatitis. Presented at the International Society of Atopic Dermatitis (ISAD) 2023 Meeting. Gdansk, Poland. 31 August – 02 September.
3. Weidinger S, et al. Atopic dermatitis. Lancet. 2016;387:1109-1122.
4. Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233-46.
5. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
6. Popovic B, et al. Structural characterisation reveals mechanism of IL-13-neutralising monoclonal antibody tralokinumab as inhibition of binding to IL-13Rα1 and IL-13Rα2. J Mol Biol. 2017; 429:208-19.
7. ClinicalTrials.gov. National Library of Medicine (U.S.). Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6). Identifier: NCT03526861. https://clinicaltrials.gov/ct2/show/NCT03526861. 
8. Blauvelt A, Langley RG, Lacour JP, et al. Long-term 2-year safety and efficacy of tralokinumab in adults with moderate-to-severe atopic dermatitis: Interim analysis of the ECZTEND open-label extension trial. J Am Acad Dermatol. 2022;87(4):815-824.
9. ClinicalTrials.gov. National Library of Medicine (U.S.). Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials – ECZTEND. Identifier: NCT03587805. https://clinicaltrials.gov/ct2/show/NCT03587805.

MAT-68073 September 2023