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Trial record 11 of 11 for:    GDC-0853

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

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ClinicalTrials.gov Identifier: NCT03693625
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

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: Fenebrutinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
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
Estimated Primary Completion Date : September 29, 2020
Estimated Study Completion Date : September 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives

Arm Intervention/treatment
Experimental: Open-label Arm
Participants will receive open-label fenebrutinib at a dose of 200 milligram (mg) orally twice a day
Drug: Fenebrutinib
200 mg orally, twice daily
Other Name: GDC-0853, RO7010939




Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events (AE) [ Time Frame: 12 Months ]

Secondary Outcome Measures :
  1. Plasma Concentrations of Fenebrutinib [ Time Frame: 12 Months ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03693625


Contacts
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Contact: Reference Study ID Number: GS40868 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

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Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT03693625     History of Changes
Other Study ID Numbers: GS40868
2018-002296-17 ( EudraCT Number )
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019

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

Additional relevant MeSH terms:
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Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases