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

• ClinicalTrials.gov Identifier: NCT03693625
• Recruitment Status: Terminated
• First Posted: October 3, 2018
• Results First Posted: September 25, 2020
• Last Update Posted: September 25, 2020
• Sponsor: Genentech, Inc.
• Information provided by (Responsible Party): Genentech, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Urticaria	Drug: GDC-0853	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 31 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: September 27, 2018
• Actual Primary Completion Date: October 23, 2019
• Actual Study Completion Date: October 23, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: GDC-0853; Participants were administered GDC-0853 200mg orally, as per the dosing schedules described above.; Other Name: fenebrutinib, RO7010939
Placebo Comparator: 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.	Drug: GDC-0853; Participants were administered GDC-0853 200mg orally, as per the dosing schedules described above.; Other Name: fenebrutinib, RO7010939

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants With Adverse Events (AEs) [ Time Frame: Baseline up until 4 weeks after the last dose of study drug (up to 10 months). ]
   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.

Secondary Outcome Measures :

1. Plasma Concentrations of Fenebrutinib (GDC-0853) at Specified Timepoints [ Time Frame: Week 1 Day 1; Weeks 12 and 24; Study Completion/Early Discontinuation ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Alabama

Clinical Research Center of Alabama, LLC

Birmingham, Alabama, United States, 35209

United States, Arizona

Allergy & Asthma Immunology Associates

Scottsdale, Arizona, United States, 85251

United States, California

Kern Allergy Med Clinic, Inc.

Bakersfield, California, United States, 93301

Southern California Research Center

Mission Viejo, California, United States, 92691

Allergy & Asthma Consultants

Redwood City, California, United States, 94063

Integrated Research Group Inc

Riverside, California, United States, 92506

United States, Florida

Renstar Medical Research

Ocala, Florida, United States, 34470

United States, Oklahoma

Vital Prospects Clinical Research Institute PC - CRN

Tulsa, Oklahoma, United States, 74136

United States, Rhode Island

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

East Providence, Rhode Island, United States, 02914

United States, Vermont

Timber Lane Allergy and Asthma Research, LLC

Burlington, Vermont, United States, 05403

Sponsors and Collaborators

Genentech, Inc.

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

  Study Documents (Full-Text)

Documents provided by Genentech, Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] August 9, 2018

More Information

• Responsible Party: Genentech, Inc.
• ClinicalTrials.gov Identifier: NCT03693625
• Other Study ID Numbers: GS40868; 2018-002296-17 ( EudraCT Number )
• First Posted: October 3, 2018
• Results First Posted: September 25, 2020
• Last Update Posted: September 25, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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

Additional relevant MeSH terms:

Urticaria; Chronic Urticaria; Skin Diseases, Vascular; Skin Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes