A Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)

PHASE3CompletedINTERVENTIONAL
Enrollment

323

Participants

Timeline

Start Date

March 31, 2011

Primary Completion Date

June 30, 2012

Study Completion Date

June 30, 2012

Conditions
Chronic Idiopathic Urticaria
Interventions
DRUG

Placebo

Placebo was supplied lyophilized in vials.

DRUG

Omalizumab

Omalizumab was supplied lyophilized in vials.

Trial Locations (61)

2900

Copenhagen

8000

Aarhus

10461

The Bronx

11203

Brooklyn

11361

Bayside

11570

Rockville Centre

13212

North Syracuse

14642

Rochester

15213

Pittsburgh

15241

Pittsburgh

16132

Genova

19140

Philadelphia

20122

Milan

20132

Milan

20902

Wheaton

21237

Baltimore

28041

Madrid

28801

Asheville

30188

Woodstock

30449

Hanover

31405

Savannah

33173

Miami

34295

Montpellier

34372

Istanbul

35100

Izmir

38039

Kayseri

44718

Canton

45231

Cincinnati

46256

Indianapolis

48149

Münster

48197

Ypsilanti

53127

Bonn

53226

Milwaukee

53715

Madison

55131

Mainz

62269

Shiloh

66210

Overland Park

68130

Omaha

68131

Omaha

75475

Paris

79903

El Paso

80206

Denver

80802

München

84070

Sandy City

90045

Los Angeles

92037

La Jolla

94063

Redwood City

94598

Walnut Creek

98105

Seattle

99204

Spokane

08724

Brick

02906

Providence

06200

Nice

D-'04103

Leipzig

80-211

Gdansk

31-913

Krakow

90-265

Lodz

02-256

Warsaw

54-239

Wroclaw

08003

Barcelona

06100

Ankara

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY