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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03693625
Other study ID # GS40868
Secondary ID 2018-002296-17
Status Terminated
Phase Phase 2
First received
Last updated
Start date September 27, 2018
Est. completion date October 23, 2019

Study information

Verified date August 2020
Source Genentech, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 31
Est. completion date October 23, 2019
Est. primary completion date October 23, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
GDC-0853
Participants were administered GDC-0853 200mg orally, as per the dosing schedules described above.

Locations

Country Name City State
United States Kern Allergy Med Clinic, Inc. Bakersfield California
United States Clinical Research Center of Alabama, LLC Birmingham Alabama
United States Timber Lane Allergy and Asthma Research, LLC Burlington Vermont
United States Asthma, Nasal Disease, and Allergy Research Center of New England East Providence Rhode Island
United States Southern California Research Center Mission Viejo California
United States Renstar Medical Research Ocala Florida
United States Allergy & Asthma Consultants Redwood City California
United States Integrated Research Group Inc Riverside California
United States Allergy & Asthma Immunology Associates Scottsdale Arizona
United States Vital Prospects Clinical Research Institute PC - CRN Tulsa Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Plasma Concentrations of Fenebrutinib (GDC-0853) at Specified Timepoints 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. Week 1 Day 1; Weeks 12 and 24; Study Completion/Early Discontinuation
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