drugset / Trial / NCT01402986
A Safety and Efficacy Study of Tralokinumab in Adults With Asthma
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to determine whether the addition of tralokinumab to standard asthma medication is effective in the treatment of adults with asthma.
Timeline
- Start
- 2011-08
- Primary completion
- 2013-06
- Completion
- 2014-02
Outcome
Missed primary endpoint
registry p = 0.709; Rate Ratio 0.94 (95% CI 0.67 to 1.31); Poisson regression NCT01402986 ↗
registry p = 0.904; Rate Ratio 1.02 (95% CI 0.71 to 1.46); Poisson regression NCT01402986 ↗
Publications
- Background Brightling CE, Chanez P, Leigh R, O'Byrne PM, Korn S, She D, May RD, Streicher K, Ranade K, Piper E. Efficacy and safety of tralokinumab in patients with severe uncontrolled asthma: a randomised, double-blind, placebo-controlled, phase 2b trial. Lancet Respir Med. 2015 Sep;3(9):692-701. doi: 10.1016/S2213-2600(15)00197-6. Epub 2015 Jul 28.
- Baverel PG, White N, Vicini P, Karlsson MO, Agoram B. Dose-Exposure-Response Relationship of the Investigational Anti-Interleukin-13 Monoclonal Antibody Tralokinumab in Patients With Severe, Uncontrolled Asthma. Clin Pharmacol Ther. 2018 May;103(5):826-835. doi: 10.1002/cpt.803. Epub 2017 Sep 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tralokinumab | Monoclonal antibody | 300 mg | Subcutaneous |