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

NCT03137069 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2020-09-29

Study results available
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Summary

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.

Conditions

  • Urticaria

Interventions

DRUG

GDC-0853

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

DRUG

Placebo

Matching Placebo will be administered orally, as per the dosing schedules described above.

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-26
Primary Completion
2019-09-27
Completion
2019-10-25
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03137069 on ClinicalTrials.gov