drugset / Trial / NCT04946318
Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to provide safety and tolerability, pharmacokinetics and immunogenicity data for multiple CSJ117 doses inhaled once daily compared with placebo, in adult asthma participants treated with medium or high dose ICS plus LABA alone or with additional asthma controllers (additional controllers allowed: LTRA, LAMA, Theophylline and its derivatives), who have completed the prior phase llb study CCSJ117A12201C (NCT04410523).
Timeline
- Start
- 2021-09-08
- Primary completion
- 2022-09-08
- Completion
- 2022-09-08
Outcome
Outcome not reported
Stopped (Business): “Sponsor Decision”
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 |