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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 1, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

October 8, 2018

Estimated Primary Completion Date

August 10, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percentage of Participants with Adverse Events (AE)[ Time Frame: 12 Months ]

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Plasma Concentrations of Fenebrutinib[ Time Frame: 12 Months ]

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

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

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Drug: Fenebrutinib
200 mg orally, twice daily

Study Arms

Experimental: Open-label Arm
Participants will receive open-label fenebrutinib at a dose of 200 milligram (mg) orally twice a day

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

165

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

August 10, 2020

Estimated Primary Completion Date

August 10, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Canada|Germany|United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Genentech, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director: Clinical Trials Hoffmann-La Roche

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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