drugset / Trial / NCT02161757
A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma
RandomizedParallel-groupTriple-blindTreatment
Summary
A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist
Timeline
- Start
- 2014-06-13
- Primary completion
- 2017-02-28
- Completion
- 2017-07-18
Outcome
Missed primary endpoint
registry analysis (superiority test); Tralo 300 mg Q2W vs Placebo; p = 0.5859; Rate ratio 0.93 (95% CI 0.72 to 1.21); Negative binomial NCT02161757 ↗
paper In the STRATOS 1 all-comers population, tralokinumab every 2 weeks did not significantly reduce AAER compared with placebo PMID 29792288 ↗
Publications
- Gottlow M, Svensson DJ, Lipkovich I, Huhn M, Bowen K, Wessman P, Colice G. Application of structured statistical analyses to identify a biomarker predictive of enhanced tralokinumab efficacy in phase III clinical trials for severe, uncontrolled asthma. BMC Pulm Med. 2019 Jul 17;19(1):129. doi: 10.1186/s12890-019-0889-4.
- Carlsson M, Braddock M, Li Y, Wang J, Xu W, White N, Megally A, Hunter G, Colice G. Evaluation of Antibody Properties and Clinically Relevant Immunogenicity, Anaphylaxis, and Hypersensitivity Reactions in Two Phase III Trials of Tralokinumab in Severe, Uncontrolled Asthma. Drug Saf. 2019 Jun;42(6):769-784. doi: 10.1007/s40264-018-00788-w.
- Panettieri RA Jr, Sjobring U, Peterffy A, Wessman P, Bowen K, Piper E, Colice G, Brightling CE. Tralokinumab for severe, uncontrolled asthma (STRATOS 1 and STRATOS 2): two randomised, double-blind, placebo-controlled, phase 3 clinical trials. Lancet Respir Med. 2018 Jul;6(7):511-525. doi: 10.1016/S2213-2600(18)30184-X. Epub 2018 May 20.
- Panettieri RA Jr, Wang M, Braddock M, Bowen K, Colice G. Tralokinumab for the treatment of severe, uncontrolled asthma: the ATMOSPHERE clinical development program. Immunotherapy. 2018 Mar 1;10(6):473-490. doi: 10.2217/imt-2017-0191. Epub 2018 Mar 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tralokinumab | Monoclonal antibody | 300 mg | Subcutaneous |