Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma
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- STATUS
- Recruiting
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- End date
- Feb 15, 2024
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- participants needed
- 625
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- sponsor
- Novartis Pharmaceuticals
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.
Description
This study is a phase IIb, multicenter, multi-national, double-blind, randomized, parallel-arm, placebo-controlled study to evaluate the effect of 5 dose levels of CSJ117 (0.5; 1; 2; 4 and 8 mg) inhaled once daily compared with placebo, when added to standard of care asthma therapy in adult subjects with inadequately controlled asthma despite medium to high dose ICS plus LABA. Approximately 625 patients will be randomized into this study.
Details
| Condition | Asthma |
|---|---|
| Treatment | Placebo, CSJ117 |
| Clinical Study Identifier | NCT04410523 |
| Sponsor | Novartis Pharmaceuticals |
| Last Modified on | 18 May 2022 |
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