CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 134 enrolled
Drug / intervention
GDC-0853 +1 moredrug
Likely dose
GDC-0853 200mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03137069
NCT03137069Phase 2Completed
CompareCT.gov

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).

Genentech, Inc.·interventional·Posted May 2, 2017·Updated Sep 29, 2020

In Brief

A Phase 2 clinical trial evaluating GDC-0853 and Placebo for Urticaria. Completed, enrolled 134 participants across 27 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrticaria
CountriesCanada, Germany, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMay 2, 2017
Enrollment StartMay 26, 2017
Primary CompletionSep 27, 2019
Study CompletionOct 25, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 9.2 years ago

Interventions

GDC-0853drug

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

Placebodrug

Matching Placebo will be administered orally, as per the dosing schedules described above.