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drugset / Trial / NCT04545385

A Study to Test if TEV-48574 is Effective in Relieving Asthma

NCT04545385 ↗

Phase 2 Terminated 65 enrolled Teva Branded Pharmaceutical Products R&D, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of the study is to evaluate the effect of TEV-48574 compared with placebo on loss of asthma control (LoAC) in adult participants with T2-low and non-T2 severe asthma uncontrolled on inhaled corticosteroids plus long-acting beta-agonists (ICS+LABA). The secondary efficacy objective is to evaluate the effect of TEV-48574 compared with placebo on a range of clinical measures of asthma control. The duration of participant participation in the study is planned to be up to approximately 30 weeks.

Timeline

Start
2020-10-07
Primary completion
2022-01-17
Completion
2022-01-17

Outcome

Missed primary endpoint

Stopped: “Met pre-specified criteria for futility at interim analysis”

registry analysis (other test); Placebo vs TEV-48574; p = 0.7817; Odds Ratio (OR) 1.49 (95% CI 0.545 to 4.071); Regression, Logistic NCT04545385 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Duvakitug Monoclonal antibody — Subcutaneous

Indications

asthma