drugset / Trial / NCT04178967
Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a randomized, double-blind, placebo-controlled, parallel-group study which is 52 weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week induction treatment period and a 36-week long-term maintenance treatment period.
Timeline
- Start
- 2019-10-29
- Primary completion
- 2021-07-12
- Completion
- 2022-04-28
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs Lebrikizumab Q2W; p = 0.000004; Risk Difference (RD) 21.9 (95% CI 14.2 to 29.6) NCT04178967 ↗
registry analysis (superiority test); Placebo vs Lebrikizumab Q2W; p <0.000001; Risk Difference (RD) 33.3 (95% CI 24.4 to 42.2) NCT04178967 ↗
release “In August 2021, Lilly announced top-line data from ADvocate 1 and ADvocate 2 showing lebrikizumab as a monotherapy met primary and all key secondary endpoints” lilly.com ↗
Publications
- Sher ER, Golant A, de Bruin-Weller M, Carrascosa JM, Mehta V, Bieber T, Dawson Z, Atwater AR, Zhong J, Rodriguez Calleja L, Boguniewicz M. Lebrikizumab is efficacious in adults and adolescents with moderate-to-severe atopic dermatitis regardless of atopic comorbidities. Ann Allergy Asthma Immunol. 2026 May;136(5):565-571. doi: 10.1016/j.anai.2025.12.017. Epub 2025 Dec 21.
- Silverberg JI, Wollenberg A, Stein Gold L, Yosipovitch G, Lio P, Vestergaard C, Stander S, Carrascosa JM, Gallo G, Casillas M, Ding Y, Yang FE, Pierce E, Agell H, Del Rosso J. Lebrikizumab provides stable skin response with no or minimal fluctuations for up to 2 years in patients with atopic dermatitis. Clin Exp Dermatol. 2026 May 26;51(6):1012-1019. doi: 10.1093/ced/llaf490.
- Guttman-Yassky E, Sun Z, Mena LR, Hahn N, Nickoloff BJ, Preuss C, Siu K, Natalie CR, Gallo G, Wolf E, Eyerich K, Aparici M, Benschop RJ, Okragly A. Lebrikizumab Rapidly Lowers Inflammatory Biomarkers with Clinical Correlations in Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2025 Sep;15(9):2595-2614. doi: 10.1007/s13555-025-01481-4. Epub 2025 Jul 15.
- Simpson E, Fernandez-Penas P, de Bruin-Weller M, Lio PA, Chu CY, Ezzedine K, Agell H, Casillas M, Ding Y, Yang FE, Pierce E, Bieber T. Improvement Across Dimensions of Disease with Lebrikizumab Use in Atopic Dermatitis: Two Phase 3, Randomized, Double-Blind, Placebo-Controlled Monotherapy Trials (ADvocate1 and ADvocate2). Adv Ther. 2025 Jan;42(1):132-143. doi: 10.1007/s12325-024-02974-y. Epub 2024 Sep 9.
- Silverberg JI, Wollenberg A, Stein Gold L, Del Rosso J, Yosipovitch G, Lio P, Carrascosa JM, Gallo G, Ding Y, Xu Z, Casillas M, Pierce E, Agell H, Stander S. Patients with Moderate-to-Severe Atopic Dermatitis Maintain Stable Response with No or Minimal Fluctuations with 1 Year of Lebrikizumab Treatment. Dermatol Ther (Heidelb). 2024 Aug;14(8):2249-2260. doi: 10.1007/s13555-024-01226-9. Epub 2024 Aug 10.
- Yosipovitch G, Lio P, Legat FJ, Chovatiya R, Deleuran M, Pierce E, Casillas M, Ding Y, Yang FE, Bardolet L, Stander S. Stable Response and Sustained Improvement of Itch and Sleep Symptoms in Patients with Atopic Dermatitis Treated with Lebrikizumab over 52 Weeks. Dermatol Ther (Heidelb). 2024 Aug;14(8):2171-2180. doi: 10.1007/s13555-024-01225-w. Epub 2024 Jul 13.
- Lio PA, Armstrong A, Gutermuth J, Nosbaum A, Sofen H, Gil EG, Casillas M, Chen S, Sun L, Pierce E, Elmaraghy H, Dawson Z, Torres T. Lebrikizumab Improves Quality of Life and Patient-Reported Symptoms of Anxiety and Depression in Patients with Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Jul;14(7):1929-1943. doi: 10.1007/s13555-024-01199-9. Epub 2024 Jun 26.
- Simpson EL, de Bruin-Weller M, Hong HC, Staumont-Salle D, Blauvelt A, Eyerich K, Gooderham M, Shahriari M, Mallbris L, Atwater AR, Rueda MJ, Ding Y, Liu Z, Agell H, Silverberg JI. Lebrikizumab Provides Rapid Clinical Responses Across All Eczema Area and Severity Index Body Regions and Clinical Signs in Adolescents and Adults with Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 May;14(5):1145-1160. doi: 10.1007/s13555-024-01158-4. Epub 2024 May 3.
- Soung J, Stander S, Gutermuth J, Pau-Charles I, Dawson Z, Yang FE, Sun L, Pierce E, Elmaraghy H, Stein-Gold L. Lebrikizumab monotherapy impacts on quality of life scores through improved itch and sleep interference in two Phase 3 trials. J Dermatolog Treat. 2024 Dec;35(1):2329240. doi: 10.1080/09546634.2024.2329240. Epub 2024 Apr 28.
- Blauvelt A, Thyssen JP, Guttman-Yassky E, Bieber T, Serra-Baldrich E, Simpson E, Rosmarin D, Elmaraghy H, Meskimen E, Natalie CR, Liu Z, Xu C, Pierce E, Morgan-Cox M, Garcia Gil E, Silverberg JI. Efficacy and safety of lebrikizumab in moderate-to-severe atopic dermatitis: 52-week results of two randomized double-blinded placebo-controlled phase III trials. Br J Dermatol. 2023 May 24;188(6):740-748. doi: 10.1093/bjd/ljad022.
- Silverberg JI, Guttman-Yassky E, Thaci D, Irvine AD, Stein Gold L, Blauvelt A, Simpson EL, Chu CY, Liu Z, Gontijo Lima R, Pillai SG, Seneschal J; ADvocate1 and ADvocate2 Investigators. Two Phase 3 Trials of Lebrikizumab for Moderate-to-Severe Atopic Dermatitis. N Engl J Med. 2023 Mar 23;388(12):1080-1091. doi: 10.1056/NEJMoa2206714. Epub 2023 Mar 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lebrikizumab | Monoclonal antibody | 250 mg | Subcutaneous |