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NCT03137069 · ClinicalTrials.gov registry record · Phase 2
A Study of GDC-0853 in Participants With Refractory Chronic Spontaneous Urticaria (CSU).
A Phase 2 study of Urticaria, sponsored by Genentech.
- Completed
- Registry status
- Phase 2
- Development phase
- 134
- Enrollment target
- 20
- Study locations
NCT03137069: Completed Phase 2 study of Urticaria, sponsored by Genentech.
NCT03137069 is a Phase 2 study of Urticaria that has completed, run by Genentech. The registered enrollment target is 134 participants, above the 16-participant average among 3 other Urticaria trials with a reported enrollment target (738% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03137069, a Phase 2 study of Urticaria, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 134 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. The maximum UAS7 value is 42. A higher s
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 |
What the finished NCT03137069 record still lists
NCT03137069 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, above the 16-participant average among 3 other Urticaria trials with a reported enrollment target (738% higher).
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.
NCT03137069 names 20 study sites across 11 states, led by California, Ontario, Florida.
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.
What interventions are being tested in trial NCT03137069?
The interventions under investigation include: Placebo (DRUG), GDC-0853 (DRUG).
Who is sponsoring clinical trial NCT03137069?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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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