Urticaria
Conditions
Brief summary
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.
Interventions
DRUGGDC-0853
Participants were administered GDC-0853 200mg orally, as per the dosing schedules described above.
Sponsors
Genentech, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Ability to comply with the study protocol, in the investigator's judgment * Completion of the treatment period as specified in the parent study * Acceptable demonstration of tolerance to study drug during the parent study as determined by the investigator or Medical Monitor * For participants receiving treatment with proton-pump inhibitors (PPIs) or H2-receptor antagonists (H2RAs), agreement to maintain treatment at a stable dose for the first 12 weeks of the study * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm
Exclusion criteria
* Pregnant or breastfeeding, or intending to become pregnant during the study or within 4 weeks after the final dose of fenebrutinib * Treatment with any investigational agent or live/attenuated vaccine in the preceding 6 weeks * Any signs or symptoms of infection judged by the investigator to be clinically significant since completing the treatment period of the parent study * Any significant changes (e.g., events, changes in medication) occurring after completion of participation in the parent study that, in the investigator's judgment, would increase the risk of adverse events in this OLE study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentrations of Fenebrutinib (GDC-0853) at Specified Timepoints | 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. |
Countries
United States
Participant flow
Recruitment details
The study was conducted at 9 centers in 1 country.
Pre-assignment details
A total of 31 participants were enrolled at 9 centers.
Participants by arm
| Arm | Count |
|---|---|
| Parent Study: GDC-0853 Participants (who had received 50, 150 and 200mg GDC-0853 in Cohort 2 of the Parent GS39684 Study) received open-label fenebrutinib/GDC-0853 at a dose of 200mg orally twice a day. | 23 |
| Parent Study: Placebo Participants (who had received Placebo in Cohort 2 of the Parent GS39684 Study) received open-label fenebrutinib/GDC-0853 at a dose of 200mg orally twice a day. | 8 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Study Terminated By Sponsor | 20 | 7 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Parent Study: Placebo | Parent Study: GDC-0853 | Total |
|---|---|---|---|
| Age, Continuous | 40.8 Years STANDARD_DEVIATION 11 | 45.7 Years STANDARD_DEVIATION 16.5 | 44.5 Years STANDARD_DEVIATION 15.3 |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 4 Participants | 4 Participants | 8 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 3 Participants | 19 Participants | 22 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 6 Participants | 20 Participants | 26 Participants |
| Sex: Female, Male Female | 6 Participants | 19 Participants | 25 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 8 |
| other Total, other adverse events | 4 / 23 | 5 / 8 |
| serious Total, serious adverse events | 0 / 23 | 0 / 8 |
Outcome results
Primary
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).
Population: The Safety-evaluable population was defined as all participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Parent Study: GDC-0853 | Percentage of Participants With Adverse Events (AEs) | 60.9 Percentage of Participants |
| Parent Study: Placebo | Percentage of Participants With Adverse Events (AEs) | 62.5 Percentage of Participants |
Secondary
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
Population: The PK population was defined as all participants who received at least one dose of study drug and had at least 1 evaluable PK sample.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parent Study: GDC-0853 | Plasma Concentrations of Fenebrutinib (GDC-0853) at Specified Timepoints | Week 1 Day 1 | NA ng/mL | — |
| Parent Study: GDC-0853 | Plasma Concentrations of Fenebrutinib (GDC-0853) at Specified Timepoints | Week 12 | 192 ng/mL | Standard Deviation 181 |
| Parent Study: GDC-0853 | Plasma Concentrations of Fenebrutinib (GDC-0853) at Specified Timepoints | Week 24 | 130 ng/mL | Standard Deviation 63.8 |
| Parent Study: GDC-0853 | Plasma Concentrations of Fenebrutinib (GDC-0853) at Specified Timepoints | Study Completion/Early Discontinuation | NA ng/mL | — |
| Parent Study: Placebo | Plasma Concentrations of Fenebrutinib (GDC-0853) at Specified Timepoints | Study Completion/Early Discontinuation | NA ng/mL | — |
| Parent Study: Placebo | Plasma Concentrations of Fenebrutinib (GDC-0853) at Specified Timepoints | Week 1 Day 1 | NA ng/mL | — |
| Parent Study: Placebo | Plasma Concentrations of Fenebrutinib (GDC-0853) at Specified Timepoints | Week 24 | 467 ng/mL | Standard Deviation 480 |
| Parent Study: Placebo | Plasma Concentrations of Fenebrutinib (GDC-0853) at Specified Timepoints | Week 12 | 190 ng/mL | Standard Deviation 278 |