Study to Test if TEV-53275 is Effective in Relieving Asthma

Study Title

A Study to Test if TEV-53275 is Effective in Relieving Asthma

Teva Identifier

TV53275-AS-20033

ClinicalTrials.gov Identifier

NCT04847674

Study Status

Terminated

Trial Condition(s)

Asthma

Interventions

Drug: TEV-53275 Dose A | Drug: TEV-53275 Dose B | Drug: Placebo

Study Description

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. The planned study duration is approximately 16 months. The total duration of study participation is approximately 34 weeks including up to a 2-week screening period, a 2-week run-in period, a 16-week treatment period, and a follow-up visit 14 weeks after the final treatment visit.


Key Participation Requirements

Gender

Female, Male

Trial Duration

May 4, 2021 - April 28, 2022

Phase

Phase 2

Additional info


Study Type

Interventional