Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials - ECZTEND

Summary

The purpose of this extension trial is to evaluate the long-term safety of tralokinumab.

Timeline

Start

2018-03-18

Primary completion

2024-07-03

Completion

2024-07-03

Publications

• Background Blauvelt A, Langley RG, Lacour JP, Toth D, Laquer V, Beissert S, Wollenberg A, Herranz P, Pink AE, Peris K, Fangel S, Gjerum L, Corriveau J, Saeki H, Warren RB, Simpson E, Reich K. 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 Oct;87(4):815-824. doi: 10.1016/j.jaad.2022.07.019. Epub 2022 Jul 19.
• Background Guttman-Yassky E, Kabashima K, Staumont-Salle D, Nahm WK, Pauser S, Da Rosa JC, Martel BC, Madsen DE, Ropke M, Arlert P, Steffensen L, Blauvelt A, Reich K. Targeting IL-13 with tralokinumab normalizes type 2 inflammation in atopic dermatitis both early and at 2 years. Allergy. 2024 Jun;79(6):1560-1572. doi: 10.1111/all.16108. Epub 2024 Apr 2.
• Background Blauvelt A, Pink A, Worm M, Langley RGB, Elewski BE, Gjerum L, Guttman-Yassky E. Outcomes of COVID-19 and Vaccination in Patients With Moderate to Severe Atopic Dermatitis Treated With Tralokinumab. JAMA Dermatol. 2022 Nov 1;158(11):1327-1330. doi: 10.1001/jamadermatol.2022.3488.
• Blauvelt A, Hong HC, Katoh N, Langley RG, Laquer V, Lesiak A, Peris K, Seneschal J, Silvestre JF, Warren RB, Wollenberg A, Zirwas M, Bennike NH, Safavimanesh F, Tindberg AM, Reich K. Long-Term Safety and Efficacy of Tralokinumab in Patients with Moderate-to-Severe Atopic Dermatitis Treated for up to 6 Years: Final Results from the Open-Label Extension Trial ECZTEND. Dermatol Ther (Heidelb). 2026 Apr;16(4):2001-2018. doi: 10.1007/s13555-026-01656-7. Epub 2026 Feb 5.
• Mayo T, Silverberg JI, Armstrong A, Guttman-Yassky E, Blauvelt A, Esdaile B, Kabashima K, Gooderham M, Kircik L, Schneider S, Bennike N, von Eyben R, Martel BC, Ropke MA, Katoh N, Alexis AF. Efficacy and Safety of Tralokinumab Across Racial Subgroups in Adults with Moderate-to-Severe Atopic Dermatitis: Post Hoc Analysis of Phase III Trials. Am J Clin Dermatol. 2026 Jan;27(1):149-166. doi: 10.1007/s40257-025-00985-1. Epub 2025 Oct 21.
• Reich K, Langley RG, Silvestre Salvador JF, Staumont-Salle D, Costanzo A, Pink AE, Paller AS, Katoh N, Wollenberg A, Warren RB, Blauvelt A, Bjerregard Oland C, Tindberg AM, Gjerum L, Simpson EL. Safety of tralokinumab in patients with moderate-to-severe atopic dermatitis followed for up to 4.5 years: an integrated analysis of eight clinical trials. Br J Dermatol. 2026 Jan 27;194(2):225-235. doi: 10.1093/bjd/ljaf309.
• Chovatiya R, Ribero S, Wollenberg A, Park CO, Silvestre JF, Hong HC, Seneschal J, Saeki H, Thyssen JP, Oland CB, Gjerum L, Maslin D, Blauvelt A. Long-Term Disease Control and Minimal Disease Activity of Head and Neck Atopic Dermatitis in Patients Treated with Tralokinumab up to 4 Years. Am J Clin Dermatol. 2025 Jul;26(4):587-601. doi: 10.1007/s40257-025-00931-1. Epub 2025 Mar 14.

Drugs

Indications