NCT03137069

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

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot and Dose-Ranging Study of GDC-0853 in Patients With Refractory Chronic Spontaneous Urticaria (CSU).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urticaria

Interventions

Type	Name	Description
DRUG	GDC-0853	GDC-0853 will be administered orally at dosages of 50, 150 and 200mg to participants, as per the dosing schedules described above.
DRUG	Placebo	Matching Placebo will be administered orally, as per the dosing schedules described above.

Timeline

• Start date: 2017-05-26
• Primary completion: 2019-09-27
• Completion: 2019-10-25
• First posted: 2017-05-02
• Last updated: 2020-09-29
• Results posted: 2020-09-29

Locations

27 sites across 3 countries: United States, Canada, Germany

Regulatory

• FDA-regulated drug study