Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma

Summary

The purpose of this study is to determine the efficacy and safety of multiple CSJ117 doses (0.5; 1; 2; 4 and 8 mg) inhaled once daily compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult patients with uncontrolled asthma with respect to change from baseline in FEV1 at the end of 12 weeks of treatment.

Timeline

Start

2020-09-09

Primary completion

2022-07-12

Completion

2022-09-06

Outcome

Met primary endpoint

Stopped: “Sponsor Desicion”

registry analysis (superiority test); CSJ117 0.5mg vs Placebo; p = 0.025; Least Squares mean 0.122 (95% CI 0.016 to 0.229); MMRM NCT04410523 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CSJ117	Protein / enzyme biologic	0.5 mg	Inhaled
Subject	CSJ117	Protein / enzyme biologic	1 mg	Inhaled
Subject	CSJ117	Protein / enzyme biologic	2 mg	Inhaled
Subject	CSJ117	Protein / enzyme biologic	4 mg	Inhaled
Subject	CSJ117	Protein / enzyme biologic	8 mg	Inhaled

Indications