TD-0903 for ALI Associated With COVID-19

Phase 2 Completed 235 enrolled Theravance Biopharma

RandomizedParallel-groupTriple-blindTreatment

Summary

This Phase 2 study will evaluate the efficacy, safety, pharmacodynamics and pharmacokinetics of inhaled TD-0903 compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with confirmed COVID-19 associated acute lung injury and impaired oxygenation.

Timeline

Start: 2020-06-24
Primary completion: 2021-04-21
Completion: 2021-04-21

Outcome

Missed primary endpoint

paper There was no statistically significant difference between nezulcitinib versus placebo in the primary endpoint (RFF days; median, 21.0 vs 21.0; p=0.6137) PMID 37460276 ↗

Publications

Belperio J, Nguyen T, Lombardi DA, Bogus M, Moskalenko V, Singh D, Haumann B, Bourdet DL, Kaufman E, Pfeifer ND, Thompson CG, Woo J, Moran EJ, Saggar R. Efficacy and safety of an inhaled pan-Janus kinase inhibitor, nezulcitinib, in hospitalised patients with COVID-19: results from a phase 2 clinical trial. BMJ Open Respir Res. 2023 Jul;10(1):e001627. doi: 10.1136/bmjresp-2023-001627.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nezulcitinib	Small molecule	3 mg	Inhaled