A Study to Evaluate the Long-term Safety and Efficacy of Fenebrutinib in Participants Previously Enrolled in a Fenebrutinib Chronic Spontaneous Urticaria (CSU) Study
Status: | Recruiting |
---|---|
Conditions: | Skin and Soft Tissue Infections, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 4/6/2019 |
Start Date: | September 27, 2018 |
End Date: | September 29, 2020 |
Contact: | Reference Study ID Number: GS40868 www.roche.com/about_roche/roche_worldwide.htm |
Email: | global-roche-genentech-trials@gene.com |
Phone: | 888-662-6728 (U.S. Only) |
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
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.
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.
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
We found this trial at
16
sites
East Providence, Rhode Island 02914
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University of South Florida The University of South Florida is a high-impact, global research university...
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