A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines

PHASE3CompletedINTERVENTIONAL
Enrollment

1,072

Participants

Timeline

Start Date

October 17, 2018

Primary Completion Date

July 16, 2021

Study Completion Date

June 14, 2022

Conditions
Chronic Spontaneous Urticaria
Interventions
BIOLOGICAL

Ligelizumab

Liquid in vial

BIOLOGICAL

Omalizumab

Lyophilized powder for solution in vial

OTHER

Placebo

Liquid in vial

Trial Locations (161)

41

Novartis Investigative Site, San Borja

123

Novartis Investigative Site, Muscat

1015

Novartis Investigative Site, Guatemala City

1407

Novartis Investigative Site, Sofia

1431

Novartis Investigative Site, Sofia

1606

Novartis Investigative Site, Sofia

2400

Novartis Investigative Site, Copenhagen NV

2730

Novartis Investigative Site, Herlev

3630

Novartis Investigative Site, Durban

4032

Novartis Investigative Site, Debrecen

5800

Novartis Investigative Site, Pleven

6000

Novartis Investigative Site, Kecskemét

6020

Novartis Investigative Site, Innsbruck

6720

Novartis Investigative Site, Szeged

7623

Novartis Investigative Site, Pécs

7700

Novartis Investigative Site, Cape Town

Novartis Investigative Site, Cape Town

9000

Novartis Investigative Site, Varna

10000

Novartis Investigative Site, Zagreb

10400

Novartis Investigative Site, Bangkok

Novartis Investigative Site, Bangkok

10700

Novartis Investigative Site, Bangkoknoi

10990

Novartis Investigative Site, George Town

11000

Novartis Investigative Site, Prague

12462

Novartis Investigative Site, Athens

13353

Novartis Investigative Site, Berlin

13620

Novartis Investigative Site, Bundang Gu

15074

Novartis Investigative Site, Miraflores

16499

Novartis Investigative Site, Suwon

18450

Novartis Investigative Site, Hwaseong-si

20070

Novartis Investigative Site, Denizli

20602

Novartis Investigative Site, Waldorf

26133

Novartis Investigative Site, Oldenburg

26426

Novartis Investigative Site, Wŏnju

27310

Novartis Investigative Site, Gaziantep

28801

Novartis Investigative Site, Asheville

29009

Novartis Investigative Site, Málaga

30450

Novartis Investigative Site, Ipoh

31400

Novartis Investigative Site, Toulouse

32308

Novartis Investigative Site, Tallahassee

33075

Novartis Investigative Site, Bordeaux

33467

Novartis Investigative Site, Greenacres City

33613

Novartis Investigative Site, Tampa

34098

Novartis Investigative Site, Istanbul

34295

Novartis Investigative Site, Montpellier

34370

Novartis Investigative Site, Okmeydanı

35039

Novartis Investigative Site, Marburg

35380

Novartis Investigative Site, Izmir

41009

Novartis Investigative Site, Seville

42602

Novartis Investigative Site, Daegu

44791

Novartis Investigative Site, Bochum

44793

Novartis Investigative Site, Bochum

45147

Novartis Investigative Site, Essen

45231

Novartis Investigative Site, Cincinnati

46256

Novartis Investigative Site, Indianapolis

47713

Novartis Investigative Site, Evansville

48013

Novartis Investigative Site, Bilbao

48197

Novartis Investigative Site, Ypsilanti

48346

Novartis Investigative Site, Clarkston

50586

Novartis Investigative Site, Kuala Lumpur

55131

Novartis Investigative Site, Mainz

55139

Novartis Investigative Site, Samsun

55441

Novartis Investigative Site, Plymouth

66211

Novartis Investigative Site, Overland Park

69495

Novartis Investigative Site, Pierre-Bénite

72205

Novartis Investigative Site, Little Rock

74136

Novartis Investigative Site, Tulsa

75230

Novartis Investigative Site, Dallas

75231

Novartis Investigative Site, Dallas

78229

Novartis Investigative Site, San Antonio

78660

Novartis Investigative Site, Pflugerville

79106

Novartis Investigative Site, Freiburg im Breisgau

80230

Novartis Investigative Site, Denver

80907

Novartis Investigative Site, Colorado Springs

81377

Novartis Investigative Site, München

83706

Novartis Investigative Site, Boise

85234

Novartis Investigative Site, Gilbert

85258

Novartis Investigative Site, Scottsdale

85340

Novartis Investigative Site, Litchfield Park

87700

Novartis Investigative Site, Memmingen

89129

Novartis Investigative Site, Langenau

90400

Novartis Investigative Site, Trévenans

90808

Novartis Investigative Site, Long Beach

91054

Novartis Investigative Site, Erlangen

92647

Novartis Investigative Site, Huntington Beach

93301

Novartis Investigative Site, Bakersfield

97504

Novartis Investigative Site, Medford

110029

Novartis Investigative Site, New Delhi

110221

Novartis Investigative Site, Bogotá

119074

Novartis Investigative Site, Singapore

123182

Novartis Investigative Site, Moscow

169608

Novartis Investigative Site, Singapore

193231

Novartis Investigative Site, Saint Petersburg

194354

Novartis Investigative Site, Saint Petersburg

214019

Novartis Investigative Site, Smolensk

229899

Novartis Investigative Site, Singapore

308205

Novartis Investigative Site, Singapore

344022

Novartis Investigative Site, Rostov-on-Don

348999

Novartis Investigative Site, Istanbul

390046

Novartis Investigative Site, Ryazan

410012

Novartis Investigative Site, Saratov

422005

Novartis Investigative Site, Nashik

520002

Novartis Investigative Site, Vijayawada

590010

Novartis Investigative Site, Belagavi

04401

Novartis Investigative Site, Bangor

05403

Novartis Investigative Site, South Burlington

C1056ABJ

Novartis Investigative Site, CABA

C1414AIF

Novartis Investigative Site, CABA

C1425BEA

Novartis Investigative Site, Ciudad Autonoma de Bs As

B1902COS

Novartis Investigative Site, La Plata

B6500BWQ

Novartis Investigative Site, Buenos Aires

B8000JRB

Novartis Investigative Site, Bahía Blanca

C1125ABE

Novartis Investigative Site, Buenos Aires

C1023AAB

Novartis Investigative Site, Capital Federal

A 1090

Novartis Investigative Site, Vienna

29025 023

Novartis Investigative Site, Vitória

06454010

Novartis Investigative Site, Alphaville Barueri

09060 650

Novartis Investigative Site, Santo André

05403 000

Novartis Investigative Site, São Paulo

L8N 3Z5

Novartis Investigative Site, Hamilton

K7L 2V7

Novartis Investigative Site, Kingston

L5A 3V4

Novartis Investigative Site, Mississauga

M3B 3S6

Novartis Investigative Site, Toronto

N2J 1C4

Novartis Investigative Site, Waterloo

H2V 2K1

Novartis Investigative Site, Montreal

G1V 4W2

Novartis Investigative Site, Québec

0050010

Novartis Investigative Site, Medellín

415 01

Novartis Investigative Site, Teplice

775 20

Novartis Investigative Site, Olomouc

305 99

Novartis Investigative Site, Pilsen

07740

Novartis Investigative Site, Jena

115 27

Novartis Investigative Site, Athens

Novartis Investigative Site, Athens

161 21

Novartis Investigative Site, Athens

01010

Novartis Investigative Site, Guatemala City

422 101

Novartis Investigative Site, Nashik

400 706

Novartis Investigative Site, Navi Mumbai

95-054

Novartis Investigative Site, Ksawerów

25-155

Novartis Investigative Site, Kielce

31-530

Novartis Investigative Site, Krakow

20-080

Novartis Investigative Site, Lublin

35 055

Novartis Investigative Site, Rzeszów

50 566

Novartis Investigative Site, Wroclaw

00927

Novartis Investigative Site, San Juan

08308

Novartis Investigative Site, Seoul

06591

Novartis Investigative Site, Seoul

405 760

Novartis Investigative Site, Incheon

03080

Novartis Investigative Site, Seoul

03722

Novartis Investigative Site, Seoul

05505

Novartis Investigative Site, Seoul

06973

Novartis Investigative Site, Seoul

07061

Novartis Investigative Site, Seoul

150-950

Novartis Investigative Site, Seoul

08907

Novartis Investigative Site, L'Hospitalet de Llobregat

08003

Novartis Investigative Site, Barcelona

08035

Novartis Investigative Site, Barcelona

08036

Novartis Investigative Site, Barcelona

03010

Novartis Investigative Site, Alicante

08041

Novartis Investigative Site, Barcelona

SE-205 02

Novartis Investigative Site, Malmo

09100

Novartis Investigative Site, Aydin

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY