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

Genentech

Status and phase: Terminated; Phase 2

Conditions: Urticaria

Treatments: Drug: GDC-0853

Study type: Interventional

Funder types: Industry

Identifiers

NCT03693625

GS40868

2018-002296-17 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 2 patient groups, including a placebo group

Parent Study: GDC-0853

Experimental group

Description:

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.

Treatment:

Drug: GDC-0853

Parent Study: Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: GDC-0853