A Study to Evaluate the Long-term Safety and Efficacy of Fenebrutinib in Participants Previously Enrolled in a Fenebrutinib Chronic Spontaneous Urticaria (CSU) Study

Urticaria Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03693625
• Other study ID #: GS40868
• Secondary ID: 2018-002296-17
• Status: Terminated
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Urticaria

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