Clinical trial NCT03693625: A Study to Evaluate the Long-term Safety and Efficacy of Fenebrutinib in Participants Previously Enrolled in a Fenebrutinib Chronic Spontaneous Urticaria (CSU) Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Urticaria
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-03
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Baseline up until 4 weeks after the last dose of study drug (up to 10 months).
Secondary outcomes:
measure: Plasma Concentrations of Fenebrutinib (GDC-0853) at Specified Timepoints
timeFrame: Week 1 Day 1; Weeks 12 and 24; Study Completion/Early Discontinuation
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama, LLC
state: Alabama
city: Scottsdale
country: United States
facility: Allergy & Asthma Immunology Associates
state: Arizona
city: Bakersfield
country: United States
facility: Kern Allergy Med Clinic, Inc.
state: California
city: Mission Viejo
country: United States
facility: Southern California Research Center
state: California
city: Redwood City
country: United States
facility: Allergy & Asthma Consultants
state: California
city: Riverside
country: United States
facility: Integrated Research Group Inc
state: California
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute PC - CRN
state: Oklahoma
city: East Providence
country: United States
facility: Asthma, Nasal Disease, and Allergy Research Center of New England
state: Rhode Island
city: Burlington
country: United States
facility: Timber Lane Allergy and Asthma Research, LLC
state: Vermont
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: