drugset / Trial / NCT04159701

A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria

NCT04159701 ↗

Phase 2 Terminated 52 enrolled Eli Lilly and Company
RandomizedCrossoverDouble-blindTreatment

Summary

The reason for this study is to see if the study drug LY3454738 is safe and effective as treatment for participants with hives that are caused by chronic spontaneous urticaria (CSU) and that are not controlled with H1-antihistamines.

Timeline

Start
2019-11-15
Primary completion
2021-02-24
Completion
2021-02-24

Outcome

Missed primary endpoint

Stopped: “The study was terminated for lack of efficacy after an interim analysis was performed”

registry analysis (superiority test); Sequence Group 1: (500 mg LY3454738, Placebo) vs Sequence Group 2: (Placebo, 500 mg LY3454738); p = 0.380 NCT04159701 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject UCENPRUBART Monoclonal antibody 500 mg Intravenous