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.

Abstract

Tralokinumab, a fully human IgG4 monoclonal antibody, specifically neutralizes IL-13. The ATMOSPHERE clinical development program comprised four randomized, placebo-controlled clinical trials and an open-label study that aimed to assess the efficacy and safety of tralokinumab for the treatment of severe, uncontrolled asthma. The two pivotal trials (STRATOS 1 and STRATOS 2; NCT02161757 and NCT02194699) evaluated the efficacy and safety of tralokinumab, with STRATOS 1 identifying a subgroup most likely to demonstrate enhanced response to treatment. Further trials have assessed the ability of tralokinumab to reduce oral corticosteroid use (TROPOS; NCT02281357) and determined its mechanistic effects (MESOS; NCT02449473). An open-label study in Japanese individuals (NCT02902809) assessed the long-term safety and tolerability of tralokinumab in this population.

Keywords: MESOS; STRATOS 1; STRATOS 2; TROPOS; airway obstruction; anti-IL-13; biomarkers; monoclonal antibody; severe asthma.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Animals
  • Anti-Asthmatic Agents / therapeutic use*
  • Antibodies, Monoclonal / therapeutic use*
  • Asthma / drug therapy*
  • Biomarkers / blood
  • Disease Progression
  • Humans
  • Interleukin-13 / blood
  • Interleukin-13 / immunology
  • Randomized Controlled Trials as Topic

Substances

  • Anti-Asthmatic Agents
  • Antibodies, Monoclonal
  • Biomarkers
  • Interleukin-13
  • tralokinumab

Associated data

  • ClinicalTrials.gov/NCT02161757
  • ClinicalTrials.gov/NCT02194699
  • ClinicalTrials.gov/NCT02281357
  • ClinicalTrials.gov/NCT02449473
  • ClinicalTrials.gov/NCT02902809