Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension.

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

470

Participants

Timeline

Start Date

November 15, 2023

Primary Completion Date

August 18, 2025

Study Completion Date

July 20, 2027

Conditions
Chronic Spontaneous Urticaria
Interventions
DRUG

Remibrutinib

Active treatment

DRUG

Placebo to remibrutinib

Placebo followed by active treatment

DRUG

Placebo to omalizumab

Placebo followed by active comparator

DRUG

Omalizumab

Active comparator

Trial Locations (111)

1000

Novartis Investigative Site, Sofia

1431

Novartis Investigative Site, Sofia

3584

Novartis Investigative Site, Utrecht

5500

Novartis Investigative Site, Mendoza

7000

Novartis Investigative Site, Ho Chi Minh City

7400

Novartis Investigative Site, Kaposvár

8091

Novartis Investigative Site, Zurich

9000

Novartis Investigative Site, Varna

10002

Novartis Investigative Site, Taipei

10400

Novartis Investigative Site, Bangkok

10450

Novartis Investigative Site, George Town

10700

Novartis Investigative Site, Bangkok

13353

Novartis Investigative Site, Berlin

14004

Novartis Investigative Site, Córdoba

17019

Novartis Investigative Site, La Rochelle

18014

Novartis Investigative Site, Granada

20070

Novartis Investigative Site, Denizli

20089

Novartis Investigative Site, Rozzano

20122

Novartis Investigative Site, Milan

21682

Novartis Investigative Site, Stade

22391

Novartis Investigative Site, Hamburg

23538

Novartis Investigative Site, Lübeck

30450

Novartis Investigative Site, Ipoh

32300

Novartis Investigative Site, Plzen Bolevec

33305

Novartis Investigative Site, Taoyuan District

34093

Novartis Investigative Site, Fatih-Istanbul

34098

Novartis Investigative Site, Istanbul

35010

Novartis Investigative Site, Las Palmas de Gran Canaria

37075

Novartis Investigative Site, Göttingen

38043

Novartis Investigative Site, Grenoble

40002

Novartis Investigative Site, Khon Kaen

41124

Novartis Investigative Site, Modena

44791

Novartis Investigative Site, Bochum

44793

Novartis Investigative Site, Bochum

45190

Novartis Investigative Site, Zapopan

46015

Novartis Investigative Site, Valencia

46026

Novartis Investigative Site, Valencia

46150

Novartis Investigative Site, Petaling Jaya

48149

Novartis Investigative Site, Münster

48455

Novartis Investigative Site, Bad Bentheim

49074

Novartis Investigative Site, Osnabrück

49241

Novartis Investigative Site, Busan

50200

Novartis Investigative Site, Chiang Mai

50586

Novartis Investigative Site, Kuala Lumpur

53100

Novartis Investigative Site, Siena

54290

Novartis Investigative Site, Sakarya

55131

Novartis Investigative Site, Mainz

59100

Novartis Investigative Site, Kuala Lumpur

62502

Novartis Investigative Site, Wilayah Persekutuan

69120

Novartis Investigative Site, Heidelberg

69495

Novartis Investigative Site, Pierre-Bénite

72076

Novartis Investigative Site, Tübingen

76031

Novartis Investigative Site, Rouen

79106

Novartis Investigative Site, Freiburg im Breisgau

80377

Novartis Investigative Site, München

81377

Novartis Investigative Site, München

84000

Novartis Investigative Site, Muar town

86035

Novartis Investigative Site, Villahermosa

90110

Novartis Investigative Site, Songkhla

91702

Novartis Investigative Site, Trnava

97070

Novartis Investigative Site, Mérida

100000

Novartis Investigative Site, Hanoi

110029

Novartis Investigative Site, New Delhi

248001

Novartis Investigative Site, Dehradun

334003

Novartis Investigative Site, Bikaner

380016

Novartis Investigative Site, Ahmedabad

422101

Novartis Investigative Site, Nashik

440012

Novartis Investigative Site, Nagpur

440015

Novartis Investigative Site, Nagpur

500004

Novartis Investigative Site, Hyderabad

560004

Novartis Investigative Site, Bangalore

570001

Novartis Investigative Site, Mysore

590010

Novartis Investigative Site, Belagavi

C1414AIF

Novartis Investigative Site, CABA

S2000DBS

Novartis Investigative Site, Rosario

B8000JRB

Novartis Investigative Site, Bahía Blanca

C1012AAY

Novartis Investigative Site, CABA

C1023AAB

Novartis Investigative Site, Capital Federal

90560 030

Novartis Investigative Site, Porto Alegre

06454010

Novartis Investigative Site, Alphaville Barueri

09060-870

Novartis Investigative Site, Santo André

18040-425

Novartis Investigative Site, Sorocaba

T6G 1C3

Novartis Investigative Site, Edmonton

L8L 3C3

Novartis Investigative Site, Hamilton

L8S 1G5

Novartis Investigative Site, Hamilton

N6H 5L5

Novartis Investigative Site, London

L2H 1H5

Novartis Investigative Site, Niagara Falls

G1V 4W2

Novartis Investigative Site, Québec

H4G 3E7

Novartis Investigative Site, Verdun

602 00

Novartis Investigative Site, Brno

100 34

Novartis Investigative Site, Prague

06000

Novartis Investigative Site, Nice

04103

Novartis Investigative Site, Leipzig

06120

Novartis Investigative Site, Halle

01307

Novartis Investigative Site, Dresden

00186

Novartis Investigative Site, Roma

06100

Novartis Investigative Site, Cuauhtémoc

80 952

Novartis Investigative Site, Gdansk

80-546

Novartis Investigative Site, Gdansk

38-400

Novartis Investigative Site, Krosno

60-823

Novartis Investigative Site, Poznan

08501

Novartis Investigative Site, Bardejov

060 01

Novartis Investigative Site, Kežmarok

08901

Novartis Investigative Site, Svidník

425-801

Novartis Investigative Site, Ansan

03722

Novartis Investigative Site, Seoul

08003

Novartis Investigative Site, Barcelona

08035

Novartis Investigative Site, Barcelona

08036

Novartis Investigative Site, Barcelona

09100

Novartis Investigative Site, Aydin

B9 5SS

Novartis Investigative Site, Birmingham

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY