An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

696

Participants

Timeline

Start Date

December 9, 2022

Primary Completion Date

August 26, 2024

Study Completion Date

August 2, 2027

Conditions
Chronic Spontaneous Urticaria
Interventions
DRUG

LOU064 (blinded)

LOU064 (blinded) active treatment

DRUG

Placebo

Placebo

DRUG

LOU064 (open label)

LOU064 (open-label) active treatment

Trial Locations (207)

1407

Novartis Investigative Site, Sofia

1431

Novartis Investigative Site, Sofia

2000

Novartis Investigative Site, Rosario

2400

Novartis Investigative Site, Kobenhavn N V

2900

Novartis Investigative Site, Hellerup

3002

Novartis Investigative Site, East Melbourne

3010

Novartis Investigative Site, Bern

3050

Novartis Investigative Site, Parkville

4026

Novartis Investigative Site, Debrecen

4032

Novartis Investigative Site, Debrecen

5800

Novartis Investigative Site, Pleven

7700

Novartis Investigative Site, Cape Town

8006

Novartis Investigative Site, Zurich

8091

Novartis Investigative Site, Zurich

10002

Novartis Investigative Site, Taipei

10400

Novartis Investigative Site, Bangkok

10450

Novartis Investigative Site, George Town

10700

Novartis Investigative Site, Bangkok

11217

Novartis Investigative Site, Taipei

13187

Novartis Investigative Site, Berlin

13353

Novartis Investigative Site, Berlin

15241

Allergy and Clinical Immunology Associates, Pittsburgh

16499

Novartis Investigative Site, Suwon

18450

Novartis Investigative Site, Hwaseong-si

20162

Novartis Investigative Site, Milan

20815

Institute for Asthma and Allergy PC, Chevy Chase

21204

John Hopkins University, Baltimore

23538

Novartis Investigative Site, Lübeck

28006

Novartis Investigative Site, Madrid

28041

Novartis Investigative Site, Madrid

29420

National Allergy and Asthma Research LLS, North Charleston

29609

Novartis Investigative Site, Brest

30450

Novartis Investigative Site, Ipoh

30625

Novartis Investigative Site, Hanover

31400

Novartis Investigative Site, Toulouse

31406

AeroAllergy Research Laboratories of Savannah Inc, Savannah

32308

Allergy and Asthma Diagnostic Treatment Center, Tallahassee

33075

Novartis Investigative Site, Bordeaux

33176

Miami Dade Medical Research, Miami

33180

Florida Ctr Allergy Asthma Research, Aventura

33305

Novartis Investigative Site, Taoyuan District

33467

Finlay Medical Research, Greenacres City

34233

Sarasota Clinical Research, Sarasota

34295

Novartis Investigative Site, Montpellier

34662

Novartis Investigative Site, Istanbul

35010

Novartis Investigative Site, Las Palmas de Gran Canaria

35039

Novartis Investigative Site, Marburg

35100

Novartis Investigative Site, Izmir

35140

Novartis Investigative Site, Izmir

35209

Allervie Clinical Research, Birmingham

35244

Cahaba Derm and skin hlth ctr 27, Birmingham

35380

Novartis Investigative Site, Izmir

35620

Novartis Investigative Site, Izmir

37075

Novartis Investigative Site, Göttingen

38039

Novartis Investigative Site, Talas Kayseri

38070

Novartis Investigative Site, Kayseri

40002

Novartis Investigative Site, Khon Kaen

42301

Allergy and Asthma Specialist P S C, Owensboro

42602

Novartis Investigative Site, Daegu

43016

CR Services Acquisition US, Dublin

43235

Optimed Research LLC, Columbus

43617

Toledo Institute of Clinical Research, Toledo

45701

Oakview Dermatology, Athens

46015

Novartis Investigative Site, Valencia

46026

Novartis Investigative Site, Valencia

46168

The Indiana Clinical Trials Center, Plainfield

47715

Deaconess Clin Allerg Res Inst, Evansville

48455

Novartis Investigative Site, Bad Bentheim

49565

Novartis Investigative Site, Bramsche

49933

Novartis Investigative Site, Angers

50200

Novartis Investigative Site, Chiang Mai

50586

Novartis Investigative Site, Kuala Lumpur

51100

Novartis Investigative Site, Reims

53228

Allergy Asthma and amp Sinus Ctr S C, Greenfield

54290

Novartis Investigative Site, Sakarya

55131

Novartis Investigative Site, Mainz

55139

Novartis Investigative Site, Samsun

60077

Endeavor Health, Glenview

60126

Novartis Investigative Site, Ancona

60305

Asthma and Allergy Center of Chicago S C, River Forest

61469

Novartis Investigative Site, Gwangju

62502

Novartis Investigative Site, Wilayah Persekutuan

63141

The Clinical Research Center, St Louis

66663

Novartis Investigative Site, Merzig

68510

Somnos Clinical Research, Lincoln

69495

Novartis Investigative Site, Pierre-Bénite

72117

Arkansas Research Trials, North Little Rock

72205

Acuro Research Inc, Little Rock

73120

Allergy Asthma and Clinical Research, Oklahoma City

74136

Vital Prospects Clinical Research Institute, Tulsa

75970

Novartis Investigative Site, Paris

76031

Novartis Investigative Site, Rouen

78213

RFSA Dermatology, San Antonio

78759

Orion Clinical Research, Austin

79924

Western Sky Medical Research, El Paso

80230

Colorado Allergy and Asthma Ctr PC, Denver

80377

Novartis Investigative Site, München

80907

Asthma and Allergy Associates P C, Colorado Springs

81377

Novartis Investigative Site, München

83706

Treasure Valley Medical Research, Boise

84000

Novartis Investigative Site, Muar town

84093

Allergy Associates of Utah, Sandy City

85340

Research Solutions of Arizona, Litchfield Park

92160

Novartis Investigative Site, Antony

93301

Kern Research, Bakersfield

93534

Antelope Valley Clinical Trials, Lancaster

94063

Allergy and Asthma Consultants, Redwood City

94160

Novartis Investigative Site, Saint-Mandé

98115

Seattle Allergy and Asthma Rsch, Seattle

98225

Bellingham Asthma Allergy and Immunology, Bellingham

100050

Novartis Investigative Site, Beijing

100191

Novartis Investigative Site, Beijing

110221

Novartis Investigative Site, Bogotá

130021

Novartis Investigative Site, Changchun

199226

Novartis Investigative Site, Saint Petersburg

200040

Novartis Investigative Site, Shanghai

200443

Novartis Investigative Site, Shanghai

214002

Novartis Investigative Site, Wuxi

280796

Novartis Investigative Site, Madrid

300052

Novartis Investigative Site, Tianjin

308205

Novartis Investigative Site, Singapore

310003

Novartis Investigative Site, Hangzhou

310016

Novartis Investigative Site, Hangzhou

355000

Novartis Investigative Site, Stavropol

390039

Novartis Investigative Site, Ryazan

390046

Novartis Investigative Site, Ryazan

407219

Novartis Investigative Site, Taichung

426061

Novartis Investigative Site, Izhevsk

430022

Novartis Investigative Site, Wuhan

510091

Novartis Investigative Site, Guangdong

510515

Novartis Investigative Site, Guangzhou

510630

Novartis Investigative Site, Guangzhou

590010

Novartis Investigative Site, Belagavi

610041

Novartis Investigative Site, Chengdu

06030-2840

UCONN Health Dermatology, Farmington

07739

Allergy Asthma Assoc Monmouth, Little Silver

C1181ACH

Novartis Investigative Site, CABA

C1414AIF

Novartis Investigative Site, CABA

B1902COS

Novartis Investigative Site, La Plata

B6500BWQ

Novartis Investigative Site, Buenos Aires

S2000JKR

Novartis Investigative Site, Rosario

B8000JRB

Novartis Investigative Site, Bahía Blanca

C1023AAB

Novartis Investigative Site, Capital Federal

S3000FIL

Novartis Investigative Site, Santa Fe

09060 650

Novartis Investigative Site, Santo André

T2M 1A6

Novartis Investigative Site, Calgary

T6G 1C3

Novartis Investigative Site, Edmonton

E3B 1G9

Novartis Investigative Site, Fredericton

K7L 2V7

Novartis Investigative Site, Kingston

N6H 5L5

Novartis Investigative Site, London

L2H 1H5

Novartis Investigative Site, Niagara Falls

K1G 6C6

Novartis Investigative Site, Ottawa

M3B 3S6

Novartis Investigative Site, Toronto

H4G 3E7

Novartis Investigative Site, Verdun

050010

Novartis Investigative Site, Medellín

080002

Novartis Investigative Site, Barranquilla

080020

Novartis Investigative Site, Barranquilla

602 00

Novartis Investigative Site, Brno

779 00

Novartis Investigative Site, Olomouc

301 00

Novartis Investigative Site, Plzen Bory

150 06

Novartis Investigative Site, Prague

06000

Novartis Investigative Site, Nice

04103

Novartis Investigative Site, Leipzig

06108

Novartis Investigative Site, Halle

06120

Novartis Investigative Site, Halle

01307

Novartis Investigative Site, Dresden

454-0012

Novartis Investigative Site, Nagoya

279-0011

Novartis Investigative Site, Urayasu

080 0013

Novartis Investigative Site, Obihiro

220-6208

Novartis Investigative Site, Yokohama

861-3106

Novartis Investigative Site, Kamimashi-gun

595-0025

Novartis Investigative Site, Izumiōtsu

572-0838

Novartis Investigative Site, Neyagawa

593-8324

Novartis Investigative Site, Sakai

569-0824

Novartis Investigative Site, Takatsuki

569-8686

Novartis Investigative Site, Takatsuki

693 8501

Novartis Investigative Site, Izumo

173-8610

Novartis Investigative Site, Itabashi-ku

136-0074

Novartis Investigative Site, Koto

108-0014

Novartis Investigative Site, Minato

143-0023

Novartis Investigative Site, Ōta-ku

734-8551

Novartis Investigative Site, Hiroshima

554 0014

Novartis Investigative Site, Osaka

558-0003

Novartis Investigative Site, Osaka

15 276

Novartis Investigative Site, Bialystok

90-265

Novartis Investigative Site, Lodz

60-693

Novartis Investigative Site, Poznan

60-823

Novartis Investigative Site, Poznan

02-507

Novartis Investigative Site, Warsaw

00985

Alma Cruz-Santana Private Practice, Carolina

060 01

Novartis Investigative Site, Kežmarok

945 01

Novartis Investigative Site, Komárno

041 90

Novartis Investigative Site, Košice

934 01

Novartis Investigative Site, Levice

940 34

Novartis Investigative Site, Nové Zámky

08901

Novartis Investigative Site, Svidník

0009

Novartis Investigative Site, Pretoria

405 760

Novartis Investigative Site, Incheon

03080

Novartis Investigative Site, Seoul

03722

Novartis Investigative Site, Seoul

07061

Novartis Investigative Site, Seoul

07441

Novartis Investigative Site, Seoul

08003

Novartis Investigative Site, Barcelona

08035

Novartis Investigative Site, Barcelona

03010

Novartis Investigative Site, Alicante

09100

Novartis Investigative Site, Aydin

CF14 4XW

Novartis Investigative Site, Cardiff

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY