NCT03693625

A Study to Evaluate the Long-term Safety and Efficacy of Fenebrutinib in Participants Previously Enrolled in a Fenebrutinib Chronic Spontaneous Urticaria (CSU) Study

A Phase II Open-Label Extension Study To Evaluate The Long-Term Safety And Efficacy Of Fenebrutinib In Patients Previously Enrolled In A Fenebrutinib Chronic Spontaneous Urticaria Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, multicenter, open-label extension (OLE) study to evaluate the long-term safety and efficacy of fenebrutinib in participants with Chronic Spontaneous Urticaria (CSU) who have completed the treatment period in a fenebrutinib CSU parent study. Participants may enroll in this OLE study at any time after completing the treatment period of the parent study. Participants will receive open-label fenebrutinib at a dose of 200 milligram (mg) orally twice a day. Treatment may continue until the end of the study.

Conditions

• Urticaria

Interventions

Type	Name	Description
DRUG	GDC-0853	Participants were administered GDC-0853 200mg orally, as per the dosing schedules described above.

Timeline

• Start date: 2018-09-27
• Primary completion: 2019-10-23
• Completion: 2019-10-23
• First posted: 2018-10-03
• Last updated: 2020-09-25
• Results posted: 2020-09-25

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study