This is a Phase II, multicenter, open-label extension (OLE) study to evaluate the long-term safety and efficacy of fenebrutinib in participants with Chronic Spontaneous Urticaria (CSU) who have completed the treatment period in a fenebrutinib CSU parent study. Participants may enroll in this OLE study at any time after completing the treatment period of the parent study. Participants will receive open-label fenebrutinib at a dose of 200 milligram (mg) orally twice a day. Treatment may continue until the end of the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Participants were administered GDC-0853 200mg orally, as per the dosing schedules described above.
Clinical Research Center of Alabama, LLC
Birmingham, Alabama, United States
Allergy & Asthma Immunology Associates
Scottsdale, Arizona, United States
Kern Allergy Med Clinic, Inc.
Bakersfield, California, United States
Southern California Research Center
Mission Viejo, California, United States
Allergy & Asthma Consultants
Redwood City, California, United States
Integrated Research Group Inc
Riverside, California, United States
Renstar Medical Research
Ocala, Florida, United States
Vital Prospects Clinical Research Institute PC - CRN
Tulsa, Oklahoma, United States
Asthma, Nasal Disease, and Allergy Research Center of New England
East Providence, Rhode Island, United States
Timber Lane Allergy and Asthma Research, LLC
Burlington, Vermont, United States
Percentage of Participants With Adverse Events (AEs)
An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events.
Time frame: Baseline up until 4 weeks after the last dose of study drug (up to 10 months).
Plasma Concentrations of Fenebrutinib (GDC-0853) at Specified Timepoints
Plasma Concentration Data for fenebrutinib (GDC-0853) will be tabulated and summarised by visits. Descriptive summary statistics for Arithmetic Mean and Standard Deviation will be presented.
Time frame: Week 1 Day 1; Weeks 12 and 24; Study Completion/Early Discontinuation
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