A Study of GDC-0853 in Participants With Refractory Chronic Spontaneous Urticaria (CSU).

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Genentech, Inc.
Study ID
NCT03137069
Phase
PHASE2
Status
Completed

Conditions

  • Urticaria

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • GDC-0853 — DRUG
    GDC-0853 will be administered orally at dosages of 50, 150 and 200mg to participants, as per the dosing schedules described above.
  • Placebo — DRUG
    Matching Placebo will be administered orally, as per the dosing schedules described above.

Study Details

The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of GDC-0853 compared with placebo in participants with Refractory Chronic Spontaneous Urticaria (CSU) already treated with anti-histamines. Participants have the option to enter the Open-Label Extension (OLE) study after completing the 8-week treatment period.

Key Dates

First listed
May 2, 2017
Start date
May 26, 2017
Status verified
Sep 2020
Primary completion
Sep 27, 2019
Completion
Oct 25, 2019

Study Design

Enrollment
134 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Cohort 1: Placebo
    Participants received matching placebo twice daily from Day 1 to 56.
  • Experimental: Cohort 1: GDC-0853 200mg BID
    Participants received GDC-0853 200mg twice daily from Day 1 to 56.
  • Placebo Comparator: Cohort 2: Placebo
    Participants received matching placebo up to twice daily from Day 1 to 56.
  • Experimental: Cohort 2: GDC-0853 50mg QD
    Participants received GDC-0853 50mg once daily from Day 1 to 56.
  • Experimental: Cohort 2: GDC-0853 150mg QD
    Participants received GDC-0853 150mg once daily from Day 1 to 56.
  • Experimental: Cohort 2: GDC-0853 200mg BID
    Participants received GDC-0853 200mg twice daily from Day 1 to 56.

Primary Outcome Measure

Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Day 57 [ Time Frame: Baseline and Day 57 ]

Locations (13)

FacilityCityStateZIPSite coordinators
Clinical Research Center of Alabama, LLCBirminghamAlabama35209-
Allergy & Asthma Immunology AssociatesScottsdaleArizona85251-
Kern Allergy Med Clinic, Inc.BakersfieldCalifornia93301-
Southern California Research CenterMission ViejoCalifornia92691-
Allergy & Asthma ConsultantsRedwood CityCalifornia94063-
Integrated Research Group IncRiversideCalifornia92506-
Integrated Research of InlandUplandCalifornia91786-
New Horizon Research CenterMiamiFlorida33165-
Renstar Medical ResearchOcalaFlorida34470-
Vital Prospects Clinical Research Institute PC - CRNTulsaOklahoma74136-
Asthma, Nasal Disease, and Allergy Research Center of New EnglandEast ProvidenceRhode Island02914-
Center for Clinical StudiesCypressTexas77433-
Timber Lane Allergy and Asthma Research, LLCBurlingtonVermont05403-

Find similar trials in Birmingham, AL

By research site
Clinical Research Center of Alabama, LLC· Birmingham, ALAllergy & Asthma Immunology Associates· Scottsdale, AZKern Allergy Med Clinic, Inc.· Bakersfield, CASouthern California Research Center· Mission Viejo, CAAllergy & Asthma Consultants· Redwood City, CAIntegrated Research Group Inc· Riverside, CA

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