A Study of GDC-0853 in Participants With Refractory Chronic Spontaneous Urticaria (CSU).

Summary

The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of GDC-0853 compared with placebo in participants with Refractory Chronic Spontaneous Urticaria (CSU) already treated with anti-histamines. Participants have the option to enter the Open-Label Extension (OLE) study after completing the 8-week treatment period.

Timeline

Start

2017-05-26

Primary completion

2019-09-27

Completion

2019-10-25

Outcome

Met primary endpoint

registry Cohort 2: Placebo vs Cohort 2: GDC-0853 200mg BID; p = 0.0097; Least Squares Mean Difference -9.53 NCT03137069 ↗

Drugs

Indications