MedTrace Logo

A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)

NCT00866788 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2017-07-11

Study results available
· View outcomes & findings →

Summary

The study is a Phase II, dose-ranging, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of a single subcutaneously administered omalizumab dose as add-on therapy for the treatment of adolescent and adult patients 12-75 years old who have been diagnosed with CIU and remain symptomatic despite treatment with therapeutic doses of an H1 antihistamine. The study will enroll approximately 76 patients at approximately 45 study centers in the United States and Germany.

Conditions

  • Chronic Idiopathic Urticaria

Interventions

DRUG

omalizumab

Administered by subcutaneous injection

DRUG

placebo

Participants received a single subcutaneous placebo injection on Day 0 of the study.

DRUG

H1 antihistamines

Patients received one of the following: Cetirizine 10 mg once per day (QD), Levocetirizine dihydrochloride 5 mg QD, Fexofenadine 60 mg twice per day or 180 mg QD, Loratadine 10 mg QD or Desloratadine 5 mg QD

DRUG

Diphenhydramine

Diphenhydramine was provided and used on an as-needed basis (25 mg per dose)

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Karin Rosen, M.D., Ph.D. · Genentech, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-01-31
Completion
2010-01-31

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 NCT00866788 on ClinicalTrials.gov