drugset / Trial / NCT02347176
Phase 2 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults With Atopic Dermatitis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The aim of the study is to evaluate the efficacy and safety of tralokinumab in adults with atopic dermatitis
Timeline
- Start
- 2015-01-23
- Primary completion
- 2015-11-27
- Completion
- 2016-02-05
Outcome
Mixed primary results
paper At week 12, 300 mg of tralokinumab significantly improved change from baseline in Eczema Area Severity Index score versus placebo PMID 29906525 ↗
registry analysis (superiority test); Placebo vs Tralokinumab Dose 3; p = 0.011; Adjusted Mean Difference -4.94 (95% CI -8.76 to -1.13); Mixed Model Repeated Measures Analysis NCT02347176 ↗
registry analysis (superiority test); Placebo vs Tralokinumab Dose 3; p = 0.061; Odds Ratio (OR) 2.83 (95% CI 0.95 to 8.37); Regression, Logistic NCT02347176 ↗
Publications
- Silverberg JI, Guttman-Yassky E, Gooderham M, Worm M, Rippon S, O'Quinn S, van der Merwe R, Kragh N, Kurbasic A, Wollenberg A. Health-related quality of life with tralokinumab in moderate-to-severe atopic dermatitis: A phase 2b randomized study. Ann Allergy Asthma Immunol. 2021 May;126(5):576-583.e4. doi: 10.1016/j.anai.2020.12.004. Epub 2020 Dec 15.
- Wollenberg A, Howell MD, Guttman-Yassky E, Silverberg JI, Kell C, Ranade K, Moate R, van der Merwe R. Treatment of atopic dermatitis with tralokinumab, an anti-IL-13 mAb. J Allergy Clin Immunol. 2019 Jan;143(1):135-141. doi: 10.1016/j.jaci.2018.05.029. Epub 2018 Jun 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tralokinumab | Monoclonal antibody | 45 mg | Subcutaneous |
| Subject | Tralokinumab | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | Tralokinumab | Monoclonal antibody | 300 mg | Subcutaneous |