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

NCT ID: NCT03693625

Last Updated: 2020-09-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-27
• Study Completion Date: 2019-10-23

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.

Conditions

Urticaria

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Parent Study: GDC-0853

Participants (who had received 50, 150 and 200mg GDC-0853 in Cohort 2 of the Parent GS39684 Study) received open-label fenebrutinib/GDC-0853 at a dose of 200mg orally twice a day.

Group Type: EXPERIMENTAL

GDC-0853

Intervention Type: DRUG

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

Parent Study: Placebo

Participants (who had received Placebo in Cohort 2 of the Parent GS39684 Study) received open-label fenebrutinib/GDC-0853 at a dose of 200mg orally twice a day.

Group Type: PLACEBO_COMPARATOR

GDC-0853

Intervention Type: DRUG

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

Interventions

GDC-0853

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

Intervention Type: DRUG

Other Intervention Names

fenebrutinib, RO7010939

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Clinical Research Center of Alabama, LLC

Birmingham, Alabama, United States

Allergy & Asthma Immunology Associates

Scottsdale, Arizona, United States

Kern Allergy Med Clinic, Inc.

Bakersfield, California, United States

Southern California Research Center

Mission Viejo, California, United States

Allergy & Asthma Consultants

Redwood City, California, United States

Integrated Research Group Inc

Riverside, California, United States

Renstar Medical Research

Ocala, Florida, United States

Vital Prospects Clinical Research Institute PC - CRN

Tulsa, Oklahoma, United States

Asthma, Nasal Disease, and Allergy Research Center of New England

East Providence, Rhode Island, United States

Timber Lane Allergy and Asthma Research, LLC

Burlington, Vermont, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2018-002296-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GS40868

Identifier Type: -

Identifier Source: org_study_id