PK/PD and Long Term Safety Study of Benralizumab in Children With Severe Eosinophilic Asthma

Summary

This study will evaluate the PK, PD and long-term safety of Benralizumab administered subcutaneously in 30 children aged 6 to 11 years with severe eosinophilic asthma. Up to an additional 3 Japanese patients aged 12 to 14 years will be enrolled to meet local regulatory requirements.

Timeline

Start

2019-11-21

Primary completion

2022-09-12

Completion

2022-09-12

Publications

• Wedner HJ, Fujisawa T, Guilbert TW, Ikeda M, Mehta V, Tam JS, Lukka PB, Asimus S, Durzynski T, Johnston J, White WI, Shah M, Werkstrom V, Jison ML; all TATE investigators. Benralizumab in children with severe eosinophilic asthma: Pharmacokinetics and long-term safety (TATE study). Pediatr Allergy Immunol. 2024 Mar;35(3):e14092. doi: 10.1111/pai.14092.

Drugs

Indications