A Study to Evaluate the Long-term Safety and Efficacy of Fenebrutinib in Participants Previously Enrolled in a Fenebrutinib Chronic Spontaneous Urticaria (CSU) Study
TerminatedPhase 2Results postedLast updated 25 September 2020
What this trial tests
Phase 2 trial testing GDC-0853 in Urticaria in 31 participants. Terminated before completion.
Adults 18 to 75, any sex, with Urticaria. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Adverse Events (AEs)Primary· Baseline up until 4 weeks after the last dose of study drug (up to 10 months).
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.
Group
Value
95% CI
Parent Study: GDC-0853
60.9
Parent Study: Placebo
62.5
Plasma Concentrations of Fenebrutinib (GDC-0853) at Specified TimepointsSecondary· Week 1 Day 1; Weeks 12 and 24; Study Completion/Early Discontinuation
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.
Week 1 Day 1
Group
Value
95% CI
Parent Study: GDC-0853
NA
± NA
Parent Study: Placebo
NA
± NA
Week 12
Group
Value
95% CI
Parent Study: GDC-0853
192
± 181
Parent Study: Placebo
190
± 278
Week 24
Group
Value
95% CI
Parent Study: GDC-0853
130
± 63.8
Parent Study: Placebo
467
± 480
Study Completion/Early Discontinuation
Group
Value
95% CI
Parent Study: GDC-0853
NA
± NA
Parent Study: Placebo
NA
± NA
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline up until 4 weeks after the last dose of study drug (up to 10 months)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03407482 — An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
· Phase 2
· terminated
NCT03137069 — A Study of GDC-0853 in Participants With Refractory Chronic Spontaneous Urticaria (CSU).
· Phase 2
· completed
NCT03174041 — A Drug-Drug Interaction Study Between GDC-0853 and Midazolam, Itraconazole, Rosuvastatin, and Simvastatin
· Phase 1
· completed
NCT03290703 — A Study to Investigate the Effect of Formulation, Food, and Rabeprazole on the Pharmacokinetics (PK) of GDC-0853 in Heal
· Phase 1
· completed
NCT03188783 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GDC-0853 in Healthy Japanese and
· Phase 1
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Genentech, Inc.
Last refreshed: 25 September 2020
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