Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab

PHASE3TerminatedINTERVENTIONAL
Enrollment

1,033

Participants

Timeline

Start Date

April 8, 2020

Primary Completion Date

September 1, 2022

Study Completion Date

September 1, 2022

Conditions
Chronic Spontaneous Urticaria
Interventions
DRUG

Ligelizumab

"For the first 12 weeks of treatment: i) participants transitioning from CQGE031C2302 (NCT03580369) and CQGE031C2303 (NCT03580356) previously treated with ligelizumab 72 mg LIVI s.c. Q4W were treated with the same dose regimen in a double-blind manner; ii) all other participants transitioning from CQGE031C2302 (NCT03580369) and CQGE031C2303 (NCT03580356) were treated with ligelizumab 120 mg LIVI s.c. Q4W in a double-blind manner; iii) participants transitioning from CQGE031C1301 (NCT03907878) and CQGE031C2202 (NCT03437278) were treated with ligelizumab 120 mg LIVI s.c. Q4W in an open-label manner.~Thereafter, all participants were switched to ligelizumab 120 mg s.c. PFS Q4W in an open-label manner and they were offered an opportunity to self-administer ligelizumab.~The longest possible treatment was 104 weeks, however this treatment might not be continuous and might span over a period of 156 weeks due to the possibility of entering the intervening observation period."

Trial Locations (273)

41

Novartis Investigative Site, San Borja

123

Novartis Investigative Site, Muscat

333

Novartis Investigative Site, Taoyuan District

652

Novartis Investigative Site, Saida

1007

Novartis Investigative Site, Tunis

1015

Novartis Investigative Site, Guatemala City

1035

Novartis Investigative Site, CABA

1090

Novartis Investigative Site, Jette

1407

Novartis Investigative Site, Sofia

1431

Novartis Investigative Site, Sofia

1605

Novartis Investigative Site, Pasig

1606

Novartis Investigative Site, Sofia

1634

Novartis Investigative Site, City of Taguig

2400

Novartis Investigative Site, Copenhagen NV

3000

Novartis Investigative Site, Leuven

3002

Novartis Investigative Site, East Melbourne

Novartis Investigative Site, Parkville

3029

Novartis Investigative Site, Sfax

3630

Novartis Investigative Site, Durban

4000

Novartis Investigative Site, Sousse

4032

Novartis Investigative Site, Debrecen

4400

Novartis Investigative Site, Salta

5000

Novartis Investigative Site, Adelaide

5800

Novartis Investigative Site, Pleven

6000

Novartis Investigative Site, Kecskemét

6280

Novartis Investigative Site, Loverval

6720

Novartis Investigative Site, Szeged

7000

Novartis Investigative Site, Ho Chi Minh City

7632

Novartis Investigative Site, Pécs

7700

Novartis Investigative Site, Cape Town

Novartis Investigative Site, Cape Town

9000

Novartis Investigative Site, Ghent

Novartis Investigative Site, Varna

10000

Novartis Investigative Site, Zagreb

10002

Novartis Investigative Site, Taipei

10138

Novartis Investigative Site, Tallinn

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

15074

Novartis Investigative Site, Miraflores

15241

Novartis Investigative Site, Pittsburgh

16499

Novartis Investigative Site, Suwon

18450

Novartis Investigative Site, Hwaseong-si

20070

Novartis Investigative Site, Denizli

20089

Novartis Investigative Site, Rozzano

21162

Novartis Investigative Site, White Marsh

21204

Novartis Investigative Site, Baltimore

21682

Novartis Investigative Site, Stade

22391

Novartis Investigative Site, Hamburg

26426

Novartis Investigative Site, Wŏnju

28041

Novartis Investigative Site, Madrid

28223

Novartis Investigative Site, Pozuelo de Alarcón

28922

Novartis Investigative Site, Alcorcón

29420

Novartis Investigative Site, North Charleston

30450

Novartis Investigative Site, Ipoh

30625

Novartis Investigative Site, Hanover

31008

Novartis Investigative Site, Pamplona

31400

Novartis Investigative Site, Toulouse

32308

Novartis Investigative Site, Tallahassee

33467

Novartis Investigative Site, Greenacres City

33609

Novartis Investigative Site, Tampa

34098

Novartis Investigative Site, Istanbul

34233

Novartis Investigative Site, Sarasota

34370

Novartis Investigative Site, Okmeydanı

35039

Novartis Investigative Site, Marburg

35209

Novartis Investigative Site, Birmingham

35380

Novartis Investigative Site, Izmir

37075

Novartis Investigative Site, Göttingen

38320

Novartis Investigative Site, San Cristóbal de La Laguna

40705

Novartis Investigative Site, Taichung

41009

Novartis Investigative Site, Seville

42602

Novartis Investigative Site, Daegu

43617

Novartis Investigative Site, Toledo

44130

Novartis Investigative Site, Guadalajara

44793

Novartis Investigative Site, Bochum

45147

Novartis Investigative Site, Essen

45231

Novartis Investigative Site, Cincinnati

46015

Novartis Investigative Site, Valencia

46026

Novartis Investigative Site, Valencia

46256

Novartis Investigative Site, Indianapolis

47713

Novartis Investigative Site, Evansville

48013

Novartis Investigative Site, Bilbao

48197

Novartis Investigative Site, Ypsilanti

48455

Novartis Investigative Site, Bad Bentheim

49074

Novartis Investigative Site, Osnabrück

50122

Novartis Investigative Site, Florence

50586

Novartis Investigative Site, Kuala Lumpur

52621

Novartis Investigative Site, Ramat Gan

53100

Novartis Investigative Site, Siena

55131

Novartis Investigative Site, Mainz

55139

Novartis Investigative Site, Samsun

55402

Novartis Investigative Site, Minneapolis

55905

Novartis Investigative Site, Rochester

59808

Novartis Investigative Site, Missoula

60590

Novartis Investigative Site, Frankfurt

63003

Novartis Investigative Site, Clermont-Ferrand

63141

Novartis Investigative Site, St Louis

66211

Novartis Investigative Site, Overland Park

69120

Novartis Investigative Site, Heidelberg

69495

Novartis Investigative Site, Pierre-Bénite

70178

Novartis Investigative Site, Stuttgart

72076

Novartis Investigative Site, Tübingen

72205

Novartis Investigative Site, Little Rock

73120

Novartis Investigative Site, Oklahoma City

74136

Novartis Investigative Site, Tulsa

76031

Novartis Investigative Site, Rouen

76100

Novartis Investigative Site, Rehovot

78229

Novartis Investigative Site, San Antonio

79106

Novartis Investigative Site, Freiburg im Breisgau

79903

Novartis Investigative Site, El Paso

80230

Novartis Investigative Site, Denver

80377

Novartis Investigative Site, München

80907

Novartis Investigative Site, Colorado Springs

81377

Novartis Investigative Site, München

83706

Novartis Investigative Site, Boise

84107

Novartis Investigative Site, Murray

85234

Novartis Investigative Site, Gilbert

85251

Novartis Investigative Site, Scottsdale

85340

Novartis Investigative Site, Litchfield Park

86035

Novartis Investigative Site, Villahermosa

87700

Novartis Investigative Site, Memmingen

89129

Novartis Investigative Site, Langenau

90025

Novartis Investigative Site, Los Angeles

91054

Novartis Investigative Site, Erlangen

93301

Novartis Investigative Site, Bakersfield

94063

Novartis Investigative Site, Redwood City

95117

Novartis Investigative Site, San Jose

95501

Novartis Investigative Site, Topoľčany

97015

Novartis Investigative Site, Clackamas

97504

Novartis Investigative Site, Medford

98225

Novartis Investigative Site, Bellingham

100000

Novartis Investigative Site, Hanoi

110029

Novartis Investigative Site, New Delhi

115478

Novartis Investigative Site, Moscow

119074

Novartis Investigative Site, Singapore

123182

Novartis Investigative Site, Moscow

166378

Novartis Investigative Site, Beirut

166830

Novartis Investigative Site, El Achrafiyé

169608

Novartis Investigative Site, Singapore

191015

Novartis Investigative Site, Saint Petersburg

191123

Novartis Investigative Site, Saint Petersburg

193231

Novartis Investigative Site, Saint Petersburg

194223

Novartis Investigative Site, Saint Petersburg

194354

Novartis Investigative Site, Saint Petersburg

195112

Novartis Investigative Site, Saint Petersburg

214019

Novartis Investigative Site, Smolensk

308205

Novartis Investigative Site, Singapore

344022

Novartis Investigative Site, Rostov-on-Don

348999

Novartis Investigative Site, Istanbul

355000

Novartis Investigative Site, Stavropol

390046

Novartis Investigative Site, Ryazan

400162

Novartis Investigative Site, Cluj-Napoca

410012

Novartis Investigative Site, Saratov

420012

Novartis Investigative Site, Kazan'

422005

Novartis Investigative Site, Nashik

422101

Novartis Investigative Site, Nashik

454048

Novartis Investigative Site, Chelyabinsk

500283

Novartis Investigative Site, Brasov

520002

Novartis Investigative Site, Vijayawada

560004

Novartis Investigative Site, Bangalore

575002

Novartis Investigative Site, Mangalore

590010

Novartis Investigative Site, Belagavi

3339419

Novartis Investigative Site, Haifa

4428164

Novartis Investigative Site, Kfar Saba

5311297

Novartis Investigative Site, Osorno

7640881

Novartis Investigative Site, Vitacura

8420383

Novartis Investigative Site, Santiago

9112001

Novartis Investigative Site, Jerusalem

04401

Novartis Investigative Site, Bangor

C1056ABJ

Novartis Investigative Site, CABA

C1181ACH

Novartis Investigative Site, CABA

C1414AIF

Novartis Investigative Site, CABA

C1425BEA

Novartis Investigative Site, Ciudad Autonoma de Bs As

B1902COS

Novartis Investigative Site, La Plata

M5500AWD

Novartis Investigative Site, Mendoza

B6500BWQ

Novartis Investigative Site, Buenos Aires

S2000DBS

Novartis Investigative Site, Santa Fe

S2000BRH

Novartis Investigative Site, Rosario

S2000JKR

Novartis Investigative Site, Rosario

B8000JRB

Novartis Investigative Site, Bahía Blanca

C1125ABE

Novartis Investigative Site, Buenos Aires

C1425DKG

Novartis Investigative Site, Buenos Aires

C1023AAB

Novartis Investigative Site, Capital Federal

A 1090

Novartis Investigative Site, Vienna

40110-060

Novartis Investigative Site, Salvador

21941-913

Novartis Investigative Site, Rio de Janeiro

06454010

Novartis Investigative Site, Alphaville Barueri

09060 650

Novartis Investigative Site, Santo André

15090 000

Novartis Investigative Site, São José do Rio Preto

05403 000

Novartis Investigative Site, São Paulo

L8N 3Z5

Novartis Investigative Site, Hamilton

K7L 2V7

Novartis Investigative Site, Kingston

M3B 3S6

Novartis Investigative Site, Toronto

N2J 1C4

Novartis Investigative Site, Waterloo

H2V 2K1

Novartis Investigative Site, Montreal

H3H 1P3

Novartis Investigative Site, Montreal

G1V 4W2

Novartis Investigative Site, Québec

0050010

Novartis Investigative Site, Medellín

415 01

Novartis Investigative Site, Teplice

779 00

Novartis Investigative Site, Olomouc

305 99

Novartis Investigative Site, Pilsen

06202

Novartis Investigative Site, Nice

01307

Novartis Investigative Site, Dresden

06097

Novartis Investigative Site, Halle

07740

Novartis Investigative Site, Jena

04103

Novartis Investigative Site, Leipzig

115 27

Novartis Investigative Site, Athens

161 21

Novartis Investigative Site, Athens

01010

Novartis Investigative Site, Guatemala City

110 060

Novartis Investigative Site, New Delhi

09042

Novartis Investigative Site, Cagliari

454-0012

Novartis Investigative Site, Nagoya

272-0033

Novartis Investigative Site, Ichikawa

818 0083

Novartis Investigative Site, Chikushino-shi

734-8551

Novartis Investigative Site, Hiroshima

080 0013

Novartis Investigative Site, Obihiro

650-0017

Novartis Investigative Site, Kobe

663-8186

Novartis Investigative Site, Nishinomiya

211-0063

Novartis Investigative Site, Kawasaki

220-6208

Novartis Investigative Site, Yokohama

221-0825

Novartis Investigative Site, Yokohama

222-0033

Novartis Investigative Site, Yokohama

861-3106

Novartis Investigative Site, Kamimashi-gun

572-0838

Novartis Investigative Site, Neyagawa

593-8324

Novartis Investigative Site, Sakai

693 8501

Novartis Investigative Site, Izumo

173-8610

Novartis Investigative Site, Itabashi-ku

194-0013

Novartis Investigative Site, Machida

158-0097

Novartis Investigative Site, Setagaya-ku

141 8625

Novartis Investigative Site, Shinagawa Ku

819 0167

Novartis Investigative Site, Fukuoka

4624 VT

Novartis Investigative Site, Bergen op Zoom

4819 EV

Novartis Investigative Site, Breda

3584CX

Novartis Investigative Site, Utrecht

95-054

Novartis Investigative Site, Ksawerów

80-402

Novartis Investigative Site, Gdansk

80-803

Novartis Investigative Site, Gdansk

31-530

Novartis Investigative Site, Krakow

90-436

Novartis Investigative Site, Lodz

35 055

Novartis Investigative Site, Rzeszów

02-507

Novartis Investigative Site, Warsaw

50 566

Novartis Investigative Site, Wroclaw

00927

Novartis Investigative Site, San Juan

020762

Novartis Investigative Site, Bucharest

060 01

Novartis Investigative Site, Kežmarok

945 01

Novartis Investigative Site, Komárno

934 01

Novartis Investigative Site, Levice

940 34

Novartis Investigative Site, Nové Zámky

017 26

Novartis Investigative Site, Považská Bystrica

08901

Novartis Investigative Site, Svidník

010 01

Novartis Investigative Site, Žilina

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

06973

Novartis Investigative Site, Seoul

07061

Novartis Investigative Site, Seoul

150-950

Novartis Investigative Site, Seoul

08950

Novartis Investigative Site, Esplugues de Llobregat

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

06100

Novartis Investigative Site, Ankara

09100

Novartis Investigative Site, Aydin

SE1 7EH

Novartis Investigative Site, London

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