NCT05030311 - A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines | Biotech Hunter

Enrollment

470

Participants

Timeline

Start Date

November 30, 2021

Primary Completion Date

December 27, 2023

Study Completion Date

January 19, 2024

Conditions

Chronic Spontaneous Urticaria

Interventions

DRUG

LOU064 25 mg (b.i.d)

LOU064 25 mg was administered by oral route twice a day (b.i.d) as a tablet.

DRUG

Placebo

DRUG

LOU064 25 mg (b.i.d) as a tablet.

LOU064 25 mg was administered by oral route twice a day (b.i.d) as a tablet in open label phase.

Trial Locations (112)

1407

Novartis Investigative Site, Sofia

1431

Novartis Investigative Site, Sofia

2010

Novartis Investigative Site, Sydney

3002

Novartis Investigative Site, East Melbourne

3050

Novartis Investigative Site, Parkville

4026

Novartis Investigative Site, Debrecen

4032

Novartis Investigative Site, Debrecen

5800

Novartis Investigative Site, Pleven

6720

Novartis Investigative Site, Szeged

10002

Novartis Investigative Site, Taipei

10128

Novartis Investigative Site, Torino

11217

Novartis Investigative Site, Taipei

16499

Novartis Investigative Site, Suwon

18450

Novartis Investigative Site, Hwaseong-si

20162

Novartis Investigative Site, Milan

20815

Novartis Investigative Site, Chevy Chase

30188

Novartis Investigative Site, Woodstock

31707

Novartis Investigative Site, Albany

32308

Novartis Investigative Site, Tallahassee

33075

Novartis Investigative Site, Bordeaux

33180

Novartis Investigative Site, Aventura

33467

Finlay Medical Research, Greenacres City

34233

Novartis Investigative Site, Sarasota

34662

Novartis Investigative Site, Istanbul

35010

Novartis Investigative Site, Las Palmas de Gran Canaria

35100

Novartis Investigative Site, Izmir

35209

Novartis Investigative Site, Birmingham

35380

Novartis Investigative Site, Izmir

35620

Novartis Investigative Site, Izmir

38039

Novartis Investigative Site, Talas Kayseri

38070

Novartis Investigative Site, Kayseri

42602

Novartis Investigative Site, Daegu

43235

Novartis Investigative Site, Columbus

43617

Novartis Investigative Site, Toledo

44130

Novartis Investigative Site, Guadalajara

45701

Novartis Investigative Site, Athens

46015

Novartis Investigative Site, Valencia

46026

Novartis Investigative Site, Valencia

47715

Novartis Investigative Site, Evansville

51100

Novartis Investigative Site, Reims

54290

Novartis Investigative Site, Sakarya

55139

Novartis Investigative Site, Samsun

56124

Novartis Investigative Site, Pisa

60126

Novartis Investigative Site, Ancona

61469

Novartis Investigative Site, Gwangju

63141

Novartis Investigative Site, St Louis

68510

Novartis Investigative Site, Lincoln

69495

Novartis Investigative Site, Pierre-Bénite

72117

Novartis Investigative Site, North Little Rock

74136

Novartis Investigative Site, Tulsa

76031

Novartis Investigative Site, Rouen

78213

Novartis Investigative Site, San Antonio

78759

Novartis Investigative Site, Austin

79924

Novartis Investigative Site, El Paso

80230

Novartis Investigative Site, Denver

84093

Novartis Investigative Site, Sandy City

86035

Novartis Investigative Site, Villahermosa

90025

Novartis Investigative Site, Los Angeles

92160

Novartis Investigative Site, Antony

93301

Novartis Investigative Site, Bakersfield

93534

Novartis Investigative Site, Lancaster

94063

Novartis Investigative Site, Redwood City

98225

Novartis Investigative Site, Bellingham

110221

Novartis Investigative Site, Bogotá

160012

Novartis Investigative Site, Chandigarh

221005

Novartis Investigative Site, Varanasi

280796

Novartis Investigative Site, Madrid

308205

Novartis Investigative Site, Singapore

422005

Novartis Investigative Site, Nashik

426061

Novartis Investigative Site, Izhevsk

440012

Novartis Investigative Site, Nagpur

440015

Novartis Investigative Site, Nagpur

500004

Novartis Investigative Site, Hyderabad

590010

Novartis Investigative Site, Belgavi

700054

Novartis Investigative Site, Kolkata

C1181ACH

Novartis Investigative Site, CABA

C1414AIF

Novartis Investigative Site, CABA

B1902COS

Novartis Investigative Site, La Plata

B6500BWQ

Novartis Investigative Site, Buenos Aires

S2000DBS

Novartis Investigative Site, Santa Fe

S2000JKR

Novartis Investigative Site, Rosario

B8000JRB

Novartis Investigative Site, Bahía Blanca

C1023AAB

Novartis Investigative Site, Capital Federal

S3000FIL

Novartis Investigative Site, Santa Fe

050010

Novartis Investigative Site, Medellín

080002

Novartis Investigative Site, Barranquilla

080020

Novartis Investigative Site, Barranquilla

656 91

Novartis Investigative Site, Brno

779 00

Novartis Investigative Site, Olomouc

305 99

Novartis Investigative Site, Pilsen

150 06

Novartis Investigative Site, Prague

06000

Novartis Investigative Site, Nice

110 060

Novartis Investigative Site, New Delhi

080 0013

Novartis Investigative Site, Obihiro

220-6208

Novartis Investigative Site, Yokohama

861-3106

Novartis Investigative Site, Kamimashi-gun

569-8686

Novartis Investigative Site, Takatsuki

136-0074

Novartis Investigative Site, Koto

819 0167

Novartis Investigative Site, Fukuoka

734-8551

Novartis Investigative Site, Hiroshima

06700

Novartis Investigative Site, Mexico City

00985

Novartis Investigative Site, Carolina

00927

Novartis Investigative Site, San Juan

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