A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1-antihistamines

PHASE3CompletedINTERVENTIONAL
Enrollment

455

Participants

Timeline

Start Date

December 1, 2021

Primary Completion Date

December 18, 2023

Study Completion Date

January 5, 2024

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 (122)

2400

Novartis Investigative Site, Copenhagen NV

2900

Novartis Investigative Site, Hellerup

3010

Novartis Investigative Site, Bern

7000

Novartis Investigative Site, Ho Chi Minh City

7700

Novartis Investigative Site, Cape Town

Novartis Investigative Site, Cape Town

8006

Novartis Investigative Site, Zurich

8091

Novartis Investigative Site, Zurich

10400

Novartis Investigative Site, Bangkok

10700

Novartis Investigative Site, Bangkoknoi

10990

Novartis Investigative Site, Pulau Pinang

13187

Novartis Investigative Site, Berlin

13353

Novartis Investigative Site, Berlin

15241

Allergy and Clinical Immunology Associates, Pittsburgh

21162

Chesapeake Clinical Research, White Marsh

21204

John Hopkins University, Baltimore

22391

Novartis Investigative Site, Hamburg

23538

Novartis Investigative Site, Lübeck

27260

Peters Medical Research, High Point

29420

National Allergy and Asthma Research LLS, North Charleston

30450

Novartis Investigative Site, Ipoh

31406

AeroAllergy Research Laboratories of Savannah Inc, Savannah

33028

Riverchase Dermatology, Pembroke Pines

33162

Ziaderm Research LLC, North Miami Beach

33176

Miami Dade Medical Research, Miami

33305

Novartis Investigative Site, Taoyuan District

33609

TrueBlue Clinical Research, Tampa

35039

Novartis Investigative Site, Marburg

35244

Cahaba Derm and skin hlth ctr 27, Birmingham

37075

Novartis Investigative Site, Göttingen

40002

Novartis Investigative Site, Khon Kaen

42301

Allergy and Asthma Specialist P S C, Owensboro

43016

CR Services Acquisition US, Dublin

44124

Ohio Clinical Research Associates, Mayfield Heights

46168

The Indiana Clinical Trials Center, Plainfield

48084

Revival Research Institute, Troy

48455

Novartis Investigative Site, Bad Bentheim

49565

Novartis Investigative Site, Bramsche

50200

Novartis Investigative Site, Chiang Mai

50586

Novartis Investigative Site, Kuala Lumpur

53228

Allergy Asthma and amp Sinus Ctr S C, Greenfield

55131

Novartis Investigative Site, Mainz

59808

Montana Medical Research, Missoula

60077

Northshore University Health System, Glenview

60305

Asthma and Allergy Center of Chicago S C, River Forest

62502

Novartis Investigative Site, Wilayah Persekutuan

66663

Novartis Investigative Site, Merzig

72076

Novartis Investigative Site, Tübingen

72205

Little Rock Allergy and Asthma Clnc, Little Rock

73120

Allergy Asthma and Clinical Research, Oklahoma City

78229

STAAMP Research LLC, San Antonio

80377

Novartis Investigative Site, München

81377

Novartis Investigative Site, München

83706

Treasure Valley Medical Research, Boise

84000

Novartis Investigative Site, Muar town

84102

Intermountain Clinical Research, Salt Lake City

85340

Research Solutions of Arizona, Litchfield Park

89129

Novartis Investigative Site, Langenau

92123

Allergy and Asthma Medical Group and Research Center, San Diego

95501

Novartis Investigative Site, Topoľčany

98115

Seattle Allergy and Asthma Rsch, Seattle

100000

Novartis Investigative Site, Hanoi

100050

Novartis Investigative Site, Beijing

100191

Novartis Investigative Site, Beijing

110011

Novartis Investigative Site, Shenyang

110029

Novartis Investigative Site, New Delhi

130021

Novartis Investigative Site, Changchun

196158

Novartis Investigative Site, Saint Petersburg

199226

Novartis Investigative Site, Saint Petersburg

200040

Novartis Investigative Site, Shanghai

200443

Novartis Investigative Site, Shanghai

214002

Novartis Investigative Site, Wuxi

248001

Novartis Investigative Site, Dehradun

300052

Novartis Investigative Site, Tianjin

310003

Novartis Investigative Site, Hangzhou

310016

Novartis Investigative Site, Hangzhou

322000

Novartis Investigative Site, Yiwu

355000

Novartis Investigative Site, Stavropol

380016

Novartis Investigative Site, Ahmedabad

390039

Novartis Investigative Site, Ryazan

390046

Novartis Investigative Site, Ryazan

395001

Novartis Investigative Site, Surat

407219

Novartis Investigative Site, Taichung

422101

Novartis Investigative Site, Nashik

430022

Novartis Investigative Site, Wuhan

440001

Novartis Investigative Site, Nagpur

440008

Novartis Investigative Site, Nagpur

510091

Novartis Investigative Site, Guangdong

510515

Novartis Investigative Site, Guangzhou

510630

Novartis Investigative Site, Guangzhou

570001

Novartis Investigative Site, Mysore

571401

Novartis Investigative Site, Bangalore

610041

Novartis Investigative Site, Chengdu

700073

Novartis Investigative Site, Kolkata

06030-2840

UCONN Health Dermatology, Farmington

07739

Allergy Asthma Assoc Monmouth, Little Silver

A 4020

Novartis Investigative Site, Linz

09715 090

Novartis Investigative Site, São Bernardo do Campo

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

01307

Novartis Investigative Site, Dresden

06108

Novartis Investigative Site, Halle

06120

Novartis Investigative Site, Halle S

04103

Novartis Investigative Site, Leipzig

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

060 01

Novartis Investigative Site, Kežmarok

041 90

Novartis Investigative Site, Košice

08901

Novartis Investigative Site, Svidník

0009

Novartis Investigative Site, Pretoria

LS9 7TF

Novartis Investigative Site, Leeds

CF14 4XW

Novartis Investigative Site, Cardiff

OX3 7LE

Novartis Investigative Site, Oxford

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY