Study Stopped
Recruitment was stopped after an interim analysis of the parent GS39684 study.
A Study to Evaluate the Long-term Safety and Efficacy of Fenebrutinib in Participants Previously Enrolled in a Fenebrutinib Chronic Spontaneous Urticaria (CSU) Study
A Phase II Open-Label Extension Study To Evaluate The Long-Term Safety And Efficacy Of Fenebrutinib In Patients Previously Enrolled In A Fenebrutinib Chronic Spontaneous Urticaria Study
2 other identifiers
interventional
31
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2018
Shorter than P25 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 27, 2018
CompletedFirst Submitted
Initial submission to the registry
October 1, 2018
CompletedFirst Posted
Study publicly available on registry
October 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 23, 2019
CompletedResults Posted
Study results publicly available
September 25, 2020
CompletedSeptember 25, 2020
August 1, 2020
1.1 years
October 1, 2018
September 2, 2020
September 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline up until 4 weeks after the last dose of study drug (up to 10 months).
Secondary Outcomes (1)
Plasma Concentrations of Fenebrutinib (GDC-0853) at Specified Timepoints
Week 1 Day 1; Weeks 12 and 24; Study Completion/Early Discontinuation
Study Arms (2)
Parent Study: GDC-0853
EXPERIMENTALParticipants (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
PLACEBO COMPARATORParticipants (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.
Interventions
Participants were administered GDC-0853 200mg orally, as per the dosing schedules described above.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (10)
Clinical Research Center of Alabama, LLC
Birmingham, Alabama, 35209, United States
Allergy & Asthma Immunology Associates
Scottsdale, Arizona, 85251, United States
Kern Allergy Med Clinic, Inc.
Bakersfield, California, 93301, United States
Southern California Research Center
Mission Viejo, California, 92691, United States
Allergy & Asthma Consultants
Redwood City, California, 94063, United States
Integrated Research Group Inc
Riverside, California, 92506, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
Vital Prospects Clinical Research Institute PC - CRN
Tulsa, Oklahoma, 74136, United States
Asthma, Nasal Disease, and Allergy Research Center of New England
East Providence, Rhode Island, 02914, United States
Timber Lane Allergy and Asthma Research, LLC
Burlington, Vermont, 05403, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Recruitment was stopped after an interim analysis of the parent GS39684 study.
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2018
First Posted
October 3, 2018
Study Start
September 27, 2018
Primary Completion
October 23, 2019
Study Completion
October 23, 2019
Last Updated
September 25, 2020
Results First Posted
September 25, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).