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

PHASE3CompletedINTERVENTIONAL
Enrollment

319

Participants

Timeline

Start Date

February 28, 2011

Primary Completion Date

October 31, 2012

Study Completion Date

October 31, 2012

Conditions
Chronic Idiopathic Urticaria
Interventions
DRUG

Omalizumab

Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.

DRUG

Placebo

Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug.

Trial Locations (66)

2400

Copenhagen

5000

Odense

10117

Berlin

10249

Berlin

10304

Staten Island

10465

The Bronx

13385

Marseille

15212

Pittsburgh

16059

Bursa

19013

Upland

20037

Washington D.C.

21224

Baltimore

22152

Springfield

27710

Durham

29406

Charleston

31003

Pamplona

31904

Columbus

32308

Tallahassee

33000

Bordeaux

33134

Coral Gables

34233

Sarasota

35100

Istanbul

35209

Birmingham

43235

Columbus

43623

Toledo

46208

Indianapolis

48149

Münster

51092

Reims

53792

Madison

54601

La Crosse

62703

Springfield

63141

St Louis

69115

Heidelberg

74136

Tulsa

76123

Fort Worth

76712

Waco

77054

Houston

79098

Freiburg im Breisgau

80112

Centennial

80337

München

84070

Sandy City

84107

Salt Lake City

90027

Los Angeles

90808

Long Beach

91607

Studio City

92647

Huntington Beach

93551

Palmdale

95817

Sacramento

97210

Portland

95117-1840

San Jose

02114

Boston

01805

Burlington

08820

Edison

08558

Skillman

D-13585

Berlin

D-01062

Dresden

06159

Perugia

00167

Roma

05100

Terni

31-531

Krakow

90-153

Lodz

20-718

Lublin

51-124

Wroclaw

08003

Barcelona

08041

Barcelona

06500

Ankara

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY