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)

Use our guide to learn which trials are right for you!

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.


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
104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
2126
mi
from 91732
Ocala, FL
Click here to add this to my saved trials
4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
2135
mi
from 91732
Tampa, FL
Click here to add this to my saved trials
2121 17th Street
Bakersfield, California 93301
106
mi
from 91732
Bakersfield, CA
Click here to add this to my saved trials
Birmingham, Alabama 35209
1785
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
Boerne, Texas 78006
1165
mi
from 91732
Boerne, TX
Click here to add this to my saved trials
2467
mi
from 91732
Burlington, VT
Click here to add this to my saved trials
2564
mi
from 91732
East Providence, RI
Click here to add this to my saved trials
Gilbert, Arizona 85234
361
mi
from 91732
Gilbert, AZ
Click here to add this to my saved trials
Mission Viejo, California 92691
38
mi
from 91732
Mission Viejo, CA
Click here to add this to my saved trials
Redwood City, California 94063
333
mi
from 91732
Redwood City, CA
Click here to add this to my saved trials
Richmond, Virginia
2268
mi
from 91732
Richmond, VA
Click here to add this to my saved trials
Riverside, California 92506
37
mi
from 91732
Riverside, CA
Click here to add this to my saved trials
Scottsdale, Arizona 85251
353
mi
from 91732
Scottsdale, AZ
Click here to add this to my saved trials
1250
mi
from 91732
Tulsa, OK
Click here to add this to my saved trials
Upland, California 91786
21
mi
from 91732
Upland, CA
Click here to add this to my saved trials
Vancouver, British Columbia
?
mi
from 91732
Vancouver,
Click here to add this to my saved trials