A Study to Test if TEV-53275 is Effective in Relieving Asthma
Summary
The primary objective of the study is to evaluate the efficacy of TEV-53275 administered subcutaneously (sc) in adult participants with persistent asthma and an eosinophilic phenotype compared to placebo. A secondary objective is to evaluate the efficacy of TEV-53275 compared to placebo assessed by lung function, asthma symptoms, rescue medication use, and quality of life measures. Another secondary objective is to evaluate the safety and tolerability of TEV-53275 administered sc in adult participants with persistent asthma and an eosinophilic phenotype compared with placebo, and lastly, to evaluate the immunogenicity of TEV-53275 administered sc in adult participants with persistent asthma and an eosinophilic phenotype.
Timeline
- Start
- 2021-05-04
- Primary completion
- 2022-04-28
- Completion
- 2022-04-28
Outcome
Missed primary endpoint
Stopped (Business): “Stopped for strategic reasons”
registry analysis (other test); Placebo vs TEV-53275 Dose A; p = 0.7914; LS mean difference -0.027 (95% CI -0.2276 to 0.1740) NCT04847674 ↗
registry analysis (other test); Placebo vs TEV-53275 Dose B; p = 0.9115; LS mean difference -0.011 (95% CI -0.2126 to 0.1900) NCT04847674 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VAROKIBART | Monoclonal antibody | — | Subcutaneous |