NCT04410523 - Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma | Biotech Hunter

Enrollment

335

Participants

Timeline

Start Date

September 9, 2020

Primary Completion Date

July 12, 2022

Study Completion Date

September 6, 2022

Conditions

Asthma

Interventions

DRUG

CSJ117

"CSJ117 inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.~CSJ117 = inhaled monoclonal antibody fragment"

DRUG

Placebo

"Run-in period (all arms): Placebo inhaled once daily (in the morning) for 4 weeks. Placebo dosing extended to 8 weeks in case of asthma exacerbation or respiratory tract infection during this period.~Treatment period (Placebo arm only): Placebo inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device."

Trial Locations (113)

1000

Novartis Investigative Site, Manila

1003

Novartis Investigative Site, Manila

1011

Novartis Investigative Site, Riga

1038

Novartis Investigative Site, Riga

1884

Novartis Investigative Site, Ranelagh, Partido de Berazate

1900

Novartis Investigative Site, Buenos Aires

2100

Novartis Investigative Site, Gödöllő

2660

Novartis Investigative Site, Balassagyarmat

2900

Novartis Investigative Site, Komárom

3020

Novartis Investigative Site, Bulacan

3100

Novartis Investigative Site, Paraná

3260

Novartis Investigative Site, Concepción del Uruguay

4000

Novartis Investigative Site, San Miguel de Tucumán

Novartis Investigative Site, Liège

5000

Novartis Investigative Site, Iloilo City

5100

Novartis Investigative Site, Erpent

5500

Novartis Investigative Site, Mendoza

6000

Novartis Investigative Site, Stara Zagora

6722

Novartis Investigative Site, Szeged

7002

Novartis Investigative Site, Rousse

7600

Novartis Investigative Site, Mar del Plata

7635

Novartis Investigative Site, Pécs

10119

Novartis Investigative Site, Berlin

10717

Novartis Investigative Site, Berlin

10969

Novartis Investigative Site, Berlin

12159

Novartis Investigative Site, Berlin

12203

Novartis Investigative Site, Berlin

14467

Novartis Investigative Site, Potsdam

15241

Novartis Investigative Site, Pittsburgh

20354

Novartis Investigative Site, Hamburg

21162

Novartis Investigative Site, White Marsh

22299

Novartis Investigative Site, Hamburg

27607

Novartis Investigative Site, Raleigh

29607

Novartis Investigative Site, Greenville

30033

Novartis Investigative Site, Krakow

30060

Novartis Investigative Site, Marietta

30173

Novartis Investigative Site, Hanover

31224

Novartis Investigative Site, Peine

40747

Novartis Investigative Site, Varnsdorf

41002

Novartis Investigative Site, Lovosice

55128

Novartis Investigative Site, Mainz

58452

Novartis Investigative Site, Witten

60596

Novartis Investigative Site, Frankfurt

63141

Novartis Investigative Site, St Louis

64283

Novartis Investigative Site, Darmstadt

65203

Novartis Investigative Site, Columbia

68134

Novartis Investigative Site, Omaha

73120

Novartis Investigative Site, Oklahoma City

75069

Novartis Investigative Site, McKinney

78006

Novartis Investigative Site, Boerne

80206

Novartis Investigative Site, Denver

90017

Novartis Investigative Site, Los Angeles

90025

Novartis Investigative Site, Los Angeles

90048

Novartis Investigative Site, Los Angeles

92647

Novartis Investigative Site, Huntington Beach

92691

Novartis Investigative Site, Mission Viejo

93301

Novartis Investigative Site, Bakersfield

93401

Novartis Investigative Site, Levice

95117

Novartis Investigative Site, San Jose

96049

Novartis Investigative Site, Bamberg

194354

Novartis Investigative Site, Saint Petersburg

410012

Novartis Investigative Site, Saratov

426061

Novartis Investigative Site, Izhevsk

432063

Novartis Investigative Site, Ulyanovsk

04401

Novartis Investigative Site, Bangor

02747-3322

Novartis Investigative Site, North Dartmouth

C1056ABJ

Novartis Investigative Site, CABA

C1122AAK

Novartis Investigative Site, CABA

C1414AIF

Novartis Investigative Site, CABA

C1425BEN

Novartis Investigative Site, CABA

E3218CHH

Novartis Investigative Site, San Salvador

S2000DBS

Novartis Investigative Site, Santa Fe

Novartis Investigative Site, Rosario

S2000JKR

Novartis Investigative Site, Rosario

T4000IFL

Novartis Investigative Site, San Miguel de Tucumán

C1125ABE

Novartis Investigative Site, Buenos Aires

C1425FVH

Novartis Investigative Site, Buenos Aires

C1430CAE

Novartis Investigative Site, CABA

L1S 2J5

Novartis Investigative Site, Ajax

L7N 3V2

Novartis Investigative Site, Burlington

M9V 4B4

Novartis Investigative Site, Etobicoke

L8N 3Z5

Novartis Investigative Site, Hamilton

H2V 2K1

Novartis Investigative Site, Montreal

G8T 7A1

Novartis Investigative Site, Trois-Rivières

415 01

Novartis Investigative Site, Teplice

377 01

Novartis Investigative Site, Jindřichův Hradec

D-04299

Novartis Investigative Site, Leipzig

D-04347

Novartis Investigative Site, Leipzig

01010

Novartis Investigative Site, Guatemala City

01011

Novartis Investigative Site, Guatemala City

223-0059

Novartis Investigative Site, Yokohama

530 0001

Novartis Investigative Site, Osaka

104-0031

Novartis Investigative Site, Chuo Ku

103-0003

Novartis Investigative Site, Chuo-ku

103-0028

Novartis Investigative Site, Chuo-ku

187-0024

Novartis Investigative Site, Kodaira

157-0072

Novartis Investigative Site, Setagaya-Ku

158-0097

Novartis Investigative Site, Setagaya-ku

170-0003

Novartis Investigative Site, Toshima City

170 0003

Novartis Investigative Site, Toshima Ku

531-0073

Novartis Investigative Site, Osaka

551-0032

Novartis Investigative Site, Osaka

LV-5401

Novartis Investigative Site, Daugavpils

LV-5417

Novartis Investigative Site, Daugavpils

LV 1002

Novartis Investigative Site, Riga

15-044

Novartis Investigative Site, Bialystok

31-011

Novartis Investigative Site, Krakow

90-153

Novartis Investigative Site, Lodz

60-693

Novartis Investigative Site, Poznan

60-823

Novartis Investigative Site, Poznan

080 01

Novartis Investigative Site, Prešov