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

Conditions

• Urticaria

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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 Dates

First listed

Oct 3, 2018

Start date

Sep 27, 2018

Status verified

Aug 2020

Primary completion

Oct 23, 2019

Completion

Oct 23, 2019

Study Design

Enrollment

31 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• 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.
• 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.

Primary Outcome Measure

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). ]

Locations (10)

Find similar trials in Birmingham, AL

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