An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU

PHASE2CompletedINTERVENTIONAL
Enrollment

229

Participants

Timeline

Start Date

October 24, 2019

Primary Completion Date

September 9, 2022

Study Completion Date

September 9, 2022

Conditions
Chronic Spontaneous Urticaria
Interventions
DRUG

LOU064

Participants with a UAS7≥16 at Week 12 or Week 16 in the CLOU064A2201, as well as participants who experienced a relapse during the 12-week observational period, were administered LOU064 50mg capsules b.i.d. (i.e. two capsules of LOU064 50mg in the morning and two capsules of LOU064 50mg in the evening) from Day 1 up to Week 52 of the Treatment period.

Trial Locations (69)

1035

Novartis Investigative Site, CABA

1085

Novartis Investigative Site, Budapest

2400

Novartis Investigative Site, Copenhagen NV

2650

Novartis Investigative Site, Edegem

4000

Novartis Investigative Site, Liège

4032

Novartis Investigative Site, Debrecen

5000

Novartis Investigative Site, Szolnok

5900

Novartis Investigative Site, Orosháza

7632

Novartis Investigative Site, Pécs

11000

Novartis Investigative Site, Prague

20070

Novartis Investigative Site, Denizli

28006

Novartis Investigative Site, Madrid

28046

Novartis Investigative Site, Madrid

33028

Novartis Investigative Site, Pembroke Pines

34098

Novartis Investigative Site, Istanbul

38039

Novartis Investigative Site, Talas / Kayseri

42301

Novartis Investigative Site, Owensboro

43123

Novartis Investigative Site, Grove City

44093

Novartis Investigative Site, Nantes

48197

Novartis Investigative Site, Ypsilanti

59037

Novartis Investigative Site, Lille

63141

Novartis Investigative Site, St Louis

72205

Novartis Investigative Site, Little Rock

85340

Novartis Investigative Site, Litchfield Park

92123

Novartis Investigative Site, San Diego

92691

Novartis Investigative Site, Mission Viejo

94598

Novartis Investigative Site, Walnut Creek

123182

Novartis Investigative Site, Moscow

194354

Novartis Investigative Site, Saint Petersburg

195112

Novartis Investigative Site, Saint Petersburg

355000

Novartis Investigative Site, Stavropol

C1414AIF

Novartis Investigative Site, CABA

B1902COS

Novartis Investigative Site, La Plata

M5500AWD

Novartis Investigative Site, Mendoza

T5K 1X3

Novartis Investigative Site, Edmonton

N6H 5L5

Novartis Investigative Site, London

L2H 1H5

Novartis Investigative Site, Niagara Falls

K1G 6C6

Novartis Investigative Site, Ottawa

G1V 4W2

Novartis Investigative Site, Québec

H4G 3E7

Novartis Investigative Site, Verdun

180 00

Novartis Investigative Site, Prague

390 01

Novartis Investigative Site, Tábor

DK 8000

Novartis Investigative Site, Arhus C

06202

Novartis Investigative Site, Nice

491-0041

Novartis Investigative Site, Ichinomiya

273-0031

Novartis Investigative Site, Funabashi

734-8551

Novartis Investigative Site, Hiroshima

080 0013

Novartis Investigative Site, Obihiro

220-6208

Novartis Investigative Site, Yokohama

221-0825

Novartis Investigative Site, Yokohama

240-0013

Novartis Investigative Site, Yokohama

173-8610

Novartis Investigative Site, Itabashi-ku

933-0871

Novartis Investigative Site, Takaoka

80 803

Novartis Investigative Site, Gdansk

90-265

Novartis Investigative Site, Lodz

90-436

Novartis Investigative Site, Lodz

35 055

Novartis Investigative Site, Rzeszów

02 777

Novartis Investigative Site, Warsaw

040 15

Novartis Investigative Site, Košice

940 34

Novartis Investigative Site, Nové Zámky

08901

Novartis Investigative Site, Svidník

08003

Novartis Investigative Site, Barcelona

08035

Novartis Investigative Site, Barcelona

08036

Novartis Investigative Site, Barcelona

03010

Novartis Investigative Site, Alicante

LS9 7TF

Novartis Investigative Site, Leeds

SE1 9RT

Novartis Investigative Site, London

OX3 7LJ

Novartis Investigative Site, Oxford

PL6 8DH

Novartis Investigative Site, Plymouth

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY