drugset / Trial / NCT03137069
A Study of GDC-0853 in Participants With Refractory Chronic Spontaneous Urticaria (CSU).
RandomizedParallel-groupQuadruple-blindTreatment
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
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fenebrutinib | Small molecule | 50 mg | Oral |
| Subject | Fenebrutinib | Small molecule | 150 mg | Oral |
| Subject | Fenebrutinib | Small molecule | 200 mg | Oral |