Trial Outcomes & Findings for A Study to Evaluate the Long-term Safety and Efficacy of Fenebrutinib in Participants Previously Enrolled in a Fenebrutinib Chronic Spontaneous Urticaria (CSU) Study (NCT NCT03693625)

Last Updated: 2020-09-25

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

31 participants

Primary outcome timeframe

Baseline up until 4 weeks after the last dose of study drug (up to 10 months).

Results posted on

2020-09-25

Participant Flow

The study was conducted at 9 centers in 1 country.

A total of 31 participants were enrolled at 9 centers.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	23	8
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	23	8

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Adverse Event	2	0
Overall Study Study Terminated By Sponsor	20	7
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

A Study to Evaluate the Long-term Safety and Efficacy of Fenebrutinib in Participants Previously Enrolled in a Fenebrutinib Chronic Spontaneous Urticaria (CSU) Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Parent Study: GDC-0853 n=23 Participants 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.	Parent Study: Placebo n=8 Participants 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.	Total n=31 Participants Total of all reporting groups
Age, Continuous	45.7 Years STANDARD_DEVIATION 16.5 • n=99 Participants	40.8 Years STANDARD_DEVIATION 11.0 • n=107 Participants	44.5 Years STANDARD_DEVIATION 15.3 • n=206 Participants
Sex: Female, Male Female	19 Participants n=99 Participants	6 Participants n=107 Participants	25 Participants n=206 Participants
Sex: Female, Male Male	4 Participants n=99 Participants	2 Participants n=107 Participants	6 Participants n=206 Participants
Race/Ethnicity, Customized Hispanic or Latino	4 Participants n=99 Participants	4 Participants n=107 Participants	8 Participants n=206 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	19 Participants n=99 Participants	3 Participants n=107 Participants	22 Participants n=206 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race/Ethnicity, Customized Asian	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Race/Ethnicity, Customized White	20 Participants n=99 Participants	6 Participants n=107 Participants	26 Participants n=206 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Parent Study: GDC-0853 n=23 Participants 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.	Parent Study: Placebo n=8 Participants 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.
Percentage of Participants With Adverse Events (AEs)	60.9 Percentage of Participants	62.5 Percentage of Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Parent Study: GDC-0853 n=23 Participants 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.	Parent Study: Placebo n=8 Participants 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.
Plasma Concentrations of Fenebrutinib (GDC-0853) at Specified Timepoints Week 1 Day 1	NA ng/mL Standard Deviation NA No Drug administered at this timepoint.	NA ng/mL Standard Deviation NA No Drug administered at this timepoint.
Plasma Concentrations of Fenebrutinib (GDC-0853) at Specified Timepoints Week 12	192 ng/mL Standard Deviation 181	190 ng/mL Standard Deviation 278
Plasma Concentrations of Fenebrutinib (GDC-0853) at Specified Timepoints Week 24	130 ng/mL Standard Deviation 63.8	467 ng/mL Standard Deviation 480
Plasma Concentrations of Fenebrutinib (GDC-0853) at Specified Timepoints Study Completion/Early Discontinuation	NA ng/mL Standard Deviation NA No Drug administered at this timepoint.	NA ng/mL Standard Deviation NA No Drug administered at this timepoint.

Adverse Events

Parent Study: GDC-0853

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Parent Study: Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	Parent Study: GDC-0853 n=23 participants at risk 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.	Parent Study: Placebo n=8 participants at risk 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.
Blood and lymphatic system disorders INCREASED TENDENCY TO BRUISE	0.00% 0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).	12.5% 1/8 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).
Gastrointestinal disorders DIARRHOEA	0.00% 0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).	12.5% 1/8 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).
Gastrointestinal disorders DYSPEPSIA	0.00% 0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).	12.5% 1/8 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.00% 0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).	12.5% 1/8 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).
Infections and infestations ABSCESS LIMB	0.00% 0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).	12.5% 1/8 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).
Infections and infestations ORAL HERPES	0.00% 0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).	12.5% 1/8 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).
Infections and infestations SKIN INFECTION	0.00% 0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).	12.5% 1/8 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).
Investigations ALANINE AMINOTRANSFERASE INCREASED	4.3% 1/23 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).	12.5% 1/8 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	4.3% 1/23 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).	12.5% 1/8 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).
Investigations BLOOD CREATINE PHOSPHOKINASE INCREASED	4.3% 1/23 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).	12.5% 1/8 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).	12.5% 1/8 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	0.00% 0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).	12.5% 1/8 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).
Musculoskeletal and connective tissue disorders MYALGIA	0.00% 0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).	12.5% 1/8 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).
Nervous system disorders HEADACHE	0.00% 0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).	12.5% 1/8 • Number of events 2 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).
Nervous system disorders MIGRAINE	0.00% 0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).	12.5% 1/8 • Number of events 2 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).
Renal and urinary disorders HAEMATURIA	0.00% 0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).	12.5% 1/8 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).
Respiratory, thoracic and mediastinal disorders COUGH	0.00% 0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).	12.5% 1/8 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).
Skin and subcutaneous tissue disorders PRURITUS	0.00% 0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).	12.5% 1/8 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).
Skin and subcutaneous tissue disorders RASH	0.00% 0/23 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).	12.5% 1/8 • Number of events 1 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).
Skin and subcutaneous tissue disorders URTICARIA	8.7% 2/23 • Number of events 2 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).	0.00% 0/8 • Baseline up until 4 weeks after the last dose of study drug (up to 10 months).