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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT03137069

Public ClinicalTrials.gov record NCT03137069. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 18, 2026, 4:11 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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).

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT03137069
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Genentech, Inc.
Industry
Enrollment
134 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 26, 2017 (Actual)
Primary completion
Sep 27, 2019 (Actual)
Completion
Oct 25, 2019 (Actual)
Last update posted
Sep 29, 2020

2017 – 2019

United States locations

U.S. sites
13
U.S. states
8
U.S. cities
13
Facility City State ZIP Site status
Clinical Research Center of Alabama, LLC Birmingham Alabama 35209 —
Allergy & Asthma Immunology Associates Scottsdale Arizona 85251 —
Kern Allergy Med Clinic, Inc. Bakersfield California 93301 —
Southern California Research Center Mission Viejo California 92691 —
Allergy & Asthma Consultants Redwood City California 94063 —
Integrated Research Group Inc Riverside California 92506 —
Integrated Research of Inland Upland California 91786 —
New Horizon Research Center Miami Florida 33165 —
Renstar Medical Research Ocala Florida 34470 —
Vital Prospects Clinical Research Institute PC - CRN Tulsa Oklahoma 74136 —
Asthma, Nasal Disease, and Allergy Research Center of New England East Providence Rhode Island 02914 —
Center for Clinical Studies Cypress Texas 77433 —
Timber Lane Allergy and Asthma Research, LLC Burlington Vermont 05403 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03137069, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 29, 2020 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03137069 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →