drugset / Trial / 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

NCT03693625

Phase 2 Terminated 31 enrolled Genentech, Inc.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2018-09-27
Primary completion
2019-10-23
Completion
2019-10-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Fenebrutinib Small molecule 200 mg Oral

Indications