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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Urticaria

In brief

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.

Key facts

Study ID

NCT03693625

Run by

Genentech, Inc.

People needed

31

Starts

2018-09-27

Expected to finish

2019-10-23

Last updated by the study team

2020-09-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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