NCT02528214 - Evaluation of Dupilumab in Patients With Severe Steroid Dependent Asthma | Biotech Hunter

Enrollment

210

Participants

Timeline

Start Date

October 15, 2015

Primary Completion Date

September 20, 2017

Study Completion Date

November 13, 2017

Conditions

Asthma

Interventions

DRUG

Dupilumab

Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.

DRUG

Placebo

Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.

DRUG

Oral corticosteroid therapy (prednisone/prednisolone)

Oral administration.

DRUG

Inhaled corticosteroid (ICS) therapy

Oral inhalation, stable dose (high dose) of ICS in combination with up to 2 other controller medicines (second or third controller therapy).

DRUG

Albuterol/Salbutamol

Oral inhalation as needed.

DRUG

Levalbuterol/Levosalbutamol

Oral inhalation as needed.

Trial Locations (80)

1020

Investigational Site Number 056002, Brussels

2660

Investigational Site Number 348301, Balassagyarmat

3000

Investigational Site Number 056001, Leuven

3780

Investigational Site Number 348303, Edelény

9000

Investigational Site Number 056003, Ghent

15213

Investigational Site Number 840010, Pittsburgh

15706

Investigational Site Number 724096, Santiago de Compostela

16132

Investigational Site Number 380002, Genova

21001

Investigational Site Number 804019, Vinnytsia

28223

Investigational Site Number 724006, Pozuelo de Alarcón

28942

Investigational Site Number 724013, Madrid

31020

Investigational Site Number 484013, Chihuahua City

34362

Investigational Site Number 376003, Haifa

36038

Investigational Site Number 804002, Poltava

39670

Investigational Site Number 484016, Acapulco

42123

Investigational Site Number 380003, Reggio Emilia

44100

Investigational Site Number 484001, Guadalajara

44281

Investigational Site Number 376001, Kfar Saba

49100

Investigational Site Number 376005, Petah Tikva

52621

Investigational Site Number 376004, Tel Litwinsky

56124

Investigational Site Number 380001, Pisa

58001

Investigational Site Number 804007, Chernivtsi

61124

Investigational Site Number 804001, Kharkiv

63110

Investigational Site Number 840002, St Louis

64460

Investigational Site Number 484003, Monterrey

65025

Investigational Site Number 804006, Odesa

75069

Investigational Site Number 840070, McKinney

75071

Investigational Site Number 840128, McKinney

75093

Investigational Site Number 840118, Plano

76018

Investigational Site Number 804004, Ivano-Frankivsk

Investigational Site Number 804009, Ivano-Frankivsk

76100

Investigational Site Number 376002, Rehovot

79106

Investigational Site Number 840062, Amarillo

80131

Investigational Site Number 380008, Napoli

90048

Investigational Site Number 840022, Los Angeles

90146

Investigational Site Number 380009, Palermo

90274

Investigational Site Number 840014, Rolling Hills Estates

95123

Investigational Site Number 380005, Catania

105077

Investigational Site Number 643006, Moscow

110121

Investigational Site Number 170001, Bogotá

117574

Investigational Site Number 643007, Moscow

193231

Investigational Site Number 643099, Saint Petersburg

194356

Investigational Site Number 643011, Saint Petersburg

197022

Investigational Site Number 643009, Saint Petersburg

300310

Investigational Site Number 642105, Timișoara

Investigational Site Number 642106, Timișoara

400162

Investigational Site Number 642102, Cluj-Napoca

400371

Investigational Site Number 642107, Cluj-Napoca

Investigational Site Number 642108, Cluj-Napoca

2260877

Investigational Site Number 152007, Quillota

3460001

Investigational Site Number 152008, Talca

7500692

Investigational Site Number 152005, Santiago

C1121ABE

Investigational Site Number 032003, Buenos Aires

C1425BEN

Investigational Site Number 032001, Caba

C1426ABP

Investigational Site Number 032091, Caba

09780-000

Investigational Site Number 076013, São Bernardo do Campo

04020-041

Investigational Site Number 076011, São Paulo

18040-425

Investigational Site Number 076002, Sorocaba

T2N 4Z6

Investigational Site Number 124009, Calgary

L8N 4A6

Investigational Site Number 124016, Hamilton

L5A 3V4

Investigational Site Number 124003, Mississauga

K1G 6C6

Investigational Site Number 124013, Ottawa

M5T 3A9

Investigational Site Number 124002, Toronto

V6Z 1Y6

Investigational Site Number 124017, Vancouver

Unknown

Investigational Site Number 170006, Bogotá

06726

Investigational Site Number 484002, Mexico City

6815 AD

Investigational Site Number 528001, Arnhem

3318 AT

Investigational Site Number 528002, Dordrecht

15-010

Investigational Site Number 616006, Bialystok

31-159

Investigational Site Number 616097, Krakow

90-141

Investigational Site Number 616001, Lodz

04-141

Investigational Site Number 616010, Warsaw

88-400

Investigational Site Number 616011, Żnin

011461

Investigational Site Number 642104, Bucharest

050159

Investigational Site Number 642103, Bucharest

08023

Investigational Site Number 724014, Barcelona

08035

Investigational Site Number 724002, Barcelona

08830

Investigational Site Number 724007, Sant Boi de Llobregat

03680

Investigational Site Number 804003, Kyiv

Investigational Site Number 804011, Kyiv