Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 2 (ECZema TRAlokinumab Trial no. 2)
Summary
Primary objective: To evaluate the efficacy of tralokinumab compared with placebo in treating moderate to severe atopic dermatitis (AD). Secondary objectives: To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health related quality of life compared with placebo. Maintenance objective: To evaluate maintenance of effect with continued tralokinumab dosing up to 52 weeks compared to placebo for subjects achieving clinical response at Week 16.
Timeline
- Start
- 2017-06-12
- Primary completion
- 2018-09-04
- Completion
- 2019-08-14
Outcome
Met primary endpoint
registry analysis (superiority test); Tralokinumab 300 mg Q2W vs Placebo Q2W; p <0.001; Risk Difference (RD) 11.1 (95% CI 5.8 to 16.4); NCT03160885 ↗
registry analysis (superiority test); Tralokinumab 300 mg Q2W vs Placebo Q2W; p <0.001; Risk Difference (RD) 21.6 (95% CI 15.8 to 27.3); NCT03160885 ↗
Publications
- 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.
- Paller AS, Soong W, Boguniewicz M, Geng B, Thyssen JP, Bennike N, Schneider S, Wollenberg A. Effect of tralokinumab on moderate-to-severe atopic dermatitis in patients with atopic comorbidities. Ann Allergy Asthma Immunol. 2025 Oct;135(4):425-433.e4. doi: 10.1016/j.anai.2025.06.022. Epub 2025 Jun 22.
- 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.
- Simpson EL, Blauvelt A, Silverberg JI, Cork MJ, Katoh N, Mark T, Schneider SKR, Wollenberg A. Tralokinumab Provides Clinically Meaningful Responses at Week 16 in Adults with Moderate-to-Severe Atopic Dermatitis Who Do Not Achieve IGA 0/1. Am J Clin Dermatol. 2024 Jan;25(1):139-148. doi: 10.1007/s40257-023-00817-0. Epub 2023 Oct 7.
- Simpson EL, Pink AE, Blauvelt A, Gooderham M, Armstrong AW, Worm M, Katoh N, Peris K, Puig L, Barbarot S, Mark T, Steffensen LA, Tindberg AM, Wollenberg A. Tralokinumab Efficacy Over 1 Year in Adults with Moderate-to-Severe Atopic Dermatitis: Pooled Data from Two Phase III Trials. Am J Clin Dermatol. 2023 Nov;24(6):939-952. doi: 10.1007/s40257-023-00806-3. Epub 2023 Sep 8.
- Blauvelt A, Gooderham M, Bhatia N, Langley RG, Schneider S, Zoidis J, Kurbasic A, Armstrong A, Silverberg JI. Tralokinumab Efficacy and Safety, with or without Topical Corticosteroids, in North American Adults with Moderate-to-Severe Atopic Dermatitis: A Subanalysis of Phase 3 Trials ECZTRA 1, 2, and 3. Dermatol Ther (Heidelb). 2022 Nov;12(11):2499-2516. doi: 10.1007/s13555-022-00805-y. Epub 2022 Sep 24.
- Wollenberg A, Blauvelt A, Guttman-Yassky E, Worm M, Lynde C, Lacour JP, Spelman L, Katoh N, Saeki H, Poulin Y, Lesiak A, Kircik L, Cho SH, Herranz P, Cork MJ, Peris K, Steffensen LA, Bang B, Kuznetsova A, Jensen TN, Osterdal ML, Simpson EL; ECZTRA 1 and ECZTRA 2 study investigators. Tralokinumab for moderate-to-severe atopic dermatitis: results from two 52-week, randomized, double-blind, multicentre, placebo-controlled phase III trials (ECZTRA 1 and ECZTRA 2). Br J Dermatol. 2021 Mar;184(3):437-449. doi: 10.1111/bjd.19574. Epub 2020 Dec 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tralokinumab | Monoclonal antibody | 300 mg | Subcutaneous |