NCT04402866

TD-0903 for ALI Associated With COVID-19

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-group, Multi-center Study of an Inhaled Pan-Janus Kinase Inhibitor, TD-0903, to Treat Symptomatic Acute Lung Injury Associated With COVID-19

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 235 (actual)
• Sponsor: Theravance Biopharma · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Part 1 of the study includes up to 3 ascending dose cohorts, each comprised of 8 subjects (6 receiving TD-0903 and 2 receiving placebo). Part 2 of the study will evaluate one dose of TD-0903 (selected based on the data from Part 1) as compared with placebo. Part 2 is targeting 198 subjects total.

Conditions

• Acute Lung Injury (ALI) Associated With COVID-19
• Lung Inflammation Associated With COVID-19

Interventions

Type	Name	Description
DRUG	TD-0903	Study Drug to be administered by inhalation
DRUG	Placebo	Placebo to be administered by inhalation

Timeline

• Start date: 2020-06-24
• Primary completion: 2021-04-21
• Completion: 2021-04-21
• First posted: 2020-05-27
• Last updated: 2022-03-17
• Results posted: 2022-03-17

Locations

24 sites across 7 countries: United States, Brazil, Finland, Moldova, Romania, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study