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A Study of GDC-0853 in Participants With Refractory Chronic Spontaneous Urticaria (CSU).
NCT03137069 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG Placebo
- DRUG GDC-0853
Study Locations (20)
California
- Kern Allergy Med Clinic, Inc. — Bakersfield
- Southern California Research Center — Mission Viejo
- Allergy & Asthma Consultants — Redwood City
- Integrated Research Group Inc — Riverside
- Integrated Research of Inland — Upland
Ontario
- Private Practice - Dr. Jason Ohayon — Hamilton
- Lynde Institute for Dermatology — Markham
- Cheema Research — Mississauga
- Yang Medicine — Ottawa
- Gordon Sussman Clinical Research — Toronto
Florida
- New Horizon Research Center — Miami
- Renstar Medical Research — Ocala
Alabama
- Clinical Research Center of Alabama, LLC — Birmingham
Arizona
- Allergy & Asthma Immunology Associates — Scottsdale
Oklahoma
- Vital Prospects Clinical Research Institute PC - CRN — Tulsa
Rhode Island
- Asthma, Nasal Disease, and Allergy Research Center of New England — East Providence
Texas
- Center for Clinical Studies — Cypress
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2017-05-26 |
| Est. Completion | 2019-10-25 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03137069
The ClinicalTrials.gov registry entry for NCT03137069 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 134 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 206 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Urticaria appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03137069 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Ontario, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03137069 about?
NCT03137069 is a clinical study titled "A Study of GDC-0853 in Participants With Refractory Chronic Spontaneous Urticaria (CSU).". 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 af...
What is the current status of trial NCT03137069?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 134 participants. The study started on 2017-05-26. Estimated completion is 2019-10-25.
What conditions does trial NCT03137069 study?
This clinical trial studies the following conditions: Urticaria. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03137069?
The interventions under investigation include: Placebo (DRUG), GDC-0853 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03137069?
This trial is sponsored by Genentech, which has 206 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03137069 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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