An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma

PHASE2CompletedINTERVENTIONAL
Enrollment

776

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

November 30, 2014

Study Completion Date

April 30, 2015

Conditions
Asthma
Interventions
DRUG

Dupilumab

Solution for injection, Subcutaneous injection

DRUG

placebo

Solution for injection, Subcutaneous injection

DRUG

ICS/LABA therapy

Oral inhalation, Prior therapy with Mometasone furoate /formoterol, budesonide / formoterol, or fluticasone propionate / salmeterol continued at stable dose

DRUG

Salbutamol/albuterol

Oral inhalation as needed

DRUG

Levosalbutamol/levalbuterol

Oral inhalation as needed

Trial Locations (201)

1424

Investigational Site Number 032008, Caba

1425

Investigational Site Number 032010, Caba

1900

Investigational Site Number 032002, La Plata

2000

Investigational Site Number 032005, Rosario

Investigational Site Number 032006, Rosario

Investigational Site Number 032007, Rosario

2560

Investigational Site Number 036005, Campbelltown

3000

Investigational Site Number 032012, Santa Fe

3004

Investigational Site Number 036009, Prahran

3168

Investigational Site Number 036001, Clayton

3199

Investigational Site Number 036008, Frankston

4000

Investigational Site Number 032009, San Miguel de Tucumán

4101

Investigational Site Number 036002, Brisbane

4102

Investigational Site Number 036006, Woolloongabba

5000

Investigational Site Number 036004, Adelaide

6009

Investigational Site Number 036003, Nedlands

6021

Investigational Site Number 554002, Wellington

7531

Investigational Site Number 710001, Cape Town

7764

Investigational Site Number 710002, Cape Town

9012

Investigational Site Number 554001, Dunedin

10003

Investigational Site Number 724004, Cáceres

10126

Investigational Site Number 380005, Torino

13915

Investigational Site Number 250001, Marseille

14618

Investigational Site Number 840016, Rochester

15213

Investigational Site Number 840010, Pittsburgh

16059

Investigational Site Number 792008, Bursa

19013

Investigational Site Number 840009, Upland

19107

Investigational Site Number 840042, Philadelphia

20902

Investigational Site Number 840052, Wheaton

21001

Investigational Site Number 804019, Vinnytsia

21287

Investigational Site Number 840028, Baltimore

23225

Investigational Site Number 840035, Richmond

27103

Investigational Site Number 840004, Papillion

27200

Investigational Site Number 250011, Vernon

28223

Investigational Site Number 724006, Pozuelo de Alarcón

29303

Investigational Site Number 840021, Spartanburg

29610

Investigational Site Number 250009, Brest

30029

Investigational Site Number 250007, Nîmes

31000

Investigational Site Number 484006, Chihuahua City

31707

Investigational Site Number 840048, Albany

32117

Investigational Site Number 840027, Daytona Beach

33070

Investigational Site Number 792006, Mersin

33135

Investigational Site Number 840039, Miami

33604

Investigational Site Number 250003, Pessac

34020

Investigational Site Number 792007, Istanbul

34098

Investigational Site Number 792001, Istanbul

Investigational Site Number 792004, Istanbul

34295

Investigational Site Number 250002, Montpellier

34844

Investigational Site Number 792003, Istanbul

35040

Investigational Site Number 792005, Izmir

35128

Investigational Site Number 380007, Padua

36038

Investigational Site Number 804002, Poltava

37126

Investigational Site Number 380006, Verona

38043

Investigational Site Number 250004, Grenoble

41124

Investigational Site Number 380003, Modena

42303

Investigational Site Number 840030, Owensboro

44093

Investigational Site Number 250005, Nantes

44100

Investigational Site Number 484001, Guadalajara

44121

Investigational Site Number 380004, Ferrara

45231

Investigational Site Number 840025, Cincinnati

45236

Investigational Site Number 840015, Cincinnati

45241

Investigational Site Number 840020, Cincinnati

47713

Investigational Site Number 840053, Evansville

48375

Investigational Site Number 840046, Novi

Investigational Site Number 840051, Novi

50134

Investigational Site Number 380002, Florence

53100

Investigational Site Number 792011, Amasya

55402

Investigational Site Number 840018, Minneapolis

56100

Investigational Site Number 380001, Pisa

59037

Investigational Site Number 250010, Lille

59804

Investigational Site Number 840037, Missoula

60126

Investigational Site Number 380010, Ancona

60305

Investigational Site Number 840026, River Forest

61124

Investigational Site Number 804001, Kharkiv

63110

Investigational Site Number 840002, St Louis

63141

Investigational Site Number 840003, St Louis

64460

Investigational Site Number 484003, Monterrey

64718

Investigational Site Number 484004, Mexico City

65025

Investigational Site Number 804006, Odesa

67091

Investigational Site Number 250008, Strasbourg

69118

Investigational Site Number 804012, Zaporizhzhya

69317

Investigational Site Number 250006, Lyon

71100

Investigational Site Number 380008, Foggia

71450

Investigational Site Number 792013, Kırıkkale

73120

Investigational Site Number 840001, Oklahoma City

75231

Investigational Site Number 840023, Dallas

78229

Investigational Site Number 840008, San Antonio

79902

Investigational Site Number 840005, El Paso

80206

Investigational Site Number 840043, Denver

80230

Investigational Site Number 840006, Denver

Investigational Site Number 840024, Denver

80907

Investigational Site Number 840032, Colorado Springs

Investigational Site Number 840040, Colorado Springs

83099

Investigational Site Number 804016, Donetsk

90025

Investigational Site Number 840019, Los Angeles

Investigational Site Number 840029, Los Angeles

90048

Investigational Site Number 840022, Los Angeles

90274

Investigational Site Number 840014, Rolling Hills Estates

92506

Investigational Site Number 840007, Riverside

92647

Investigational Site Number 840041, Huntington Beach

92663

Investigational Site Number 840044, Newport Beach

92691

Investigational Site Number 840013, Mission Viejo

92835

Investigational Site Number 840050, Fullerton

95117

Investigational Site Number 840036, San Jose

95123

Investigational Site Number 380009, Catania

97035

Investigational Site Number 840031, Lake Oswego

97504

Investigational Site Number 840034, Medford

98203

Investigational Site Number 840054, Everett

98405

Investigational Site Number 840033, Tacoma

98603

Investigational Site Number 804015, Yalta

105229

Investigational Site Number 643003, Moscow

109240

Investigational Site Number 643002, Moscow

115446

Investigational Site Number 643007, Moscow

123182

Investigational Site Number 643012, Moscow

125367

Investigational Site Number 643001, Moscow

150003

Investigational Site Number 643008, Yaroslavl

194354

Investigational Site Number 643010, Saint Petersburg

196356

Investigational Site Number 643011, Saint Petersburg

197022

Investigational Site Number 643009, Saint Petersburg

226000

Investigational Site Number 152007, Quillota

630091

Investigational Site Number 643006, Novosibirsk

7500710

Investigational Site Number 152001, Santiago

8380456

Investigational Site Number 152002, Santiago

8910131

Investigational Site Number 152014, Santiago

40223-5440

Investigational Site Number 840017, Louisville

02747

Investigational Site Number 840045, North Dartmouth

08540

Investigational Site Number 840011, Princeton

B6500BWQ

Investigational Site Number 032004, Buenos Aires

C1121ABE

Investigational Site Number 032003, Buenos Aires

Unknown

Investigational Site Number 032001, Caba

Investigational Site Number 152003, Santiago

Investigational Site Number 152005, Santiago

Investigational Site Number 152012, Santiago

Investigational Site Number 152013, Santiago

Investigational Site Number 152008, Talca

Investigational Site Number 152006, Viña del Mar

Investigational Site Number 392009, Asahi-Shi

Investigational Site Number 392037, Chiyoda-Ku

Investigational Site Number 392007, Chuoh-Ku

Investigational Site Number 392002, Chūōku

Investigational Site Number 392012, Edogawa-Ku

Investigational Site Number 392017, Fukuoka

Investigational Site Number 392021, Fukuyama-Shi

Investigational Site Number 392030, Habikino-Shi

Investigational Site Number 392004, Himeji-Shi

Investigational Site Number 392032, Hirakata-Shi

Investigational Site Number 392013, Iizuka-Shi

Investigational Site Number 392042, Isesaki-Shi

Investigational Site Number 392026, Itabashi-Ku

Investigational Site Number 392023, Kanazawa

Investigational Site Number 392001, Kitakyushu-Shi

Investigational Site Number 392022, Kiyose-Shi

Investigational Site Number 392025, Kobe

Investigational Site Number 392040, Kodaira-Shi

Investigational Site Number 392044, Kokubunji-Shi

Investigational Site Number 392010, Kurashiki-Shi

Investigational Site Number 392036, Kyoto

Investigational Site Number 392041, Nagaoka-Shi

Investigational Site Number 392020, Naka-Gun

Investigational Site Number 392015, Nakano

Investigational Site Number 392005, Naruto-Shi

Investigational Site Number 392043, Ohta-Shi

Investigational Site Number 392019, Sagamihara-Shi

Investigational Site Number 392011, Sakaide-Shi

Investigational Site Number 392024, Sakaishi

Investigational Site Number 392008, Sapporo

Investigational Site Number 392034, Sapporo

Investigational Site Number 392038, Setagaya-Ku

Investigational Site Number 392028, Sumida-Ku

Investigational Site Number 392006, Tomakomai-Shi

Investigational Site Number 392003, Toride-Shi

Investigational Site Number 392029, Tsu

Investigational Site Number 392018, Tsukubo-Gun

Investigational Site Number 392045, Uruma

Investigational Site Number 392014, Yokohama

Investigational Site Number 392035, Yokohama

00000

Investigational Site Number 152011, Santiago

07760

Investigational Site Number 484005, Distrito Federal

15-025

Investigational Site Number 616006, Bialystok

80-405

Investigational Site Number 616004, Gdansk

80-952

Investigational Site Number 616003, Gdansk

31-159

Investigational Site Number 616007, Krakow

90-153

Investigational Site Number 616001, Lodz

Investigational Site Number 616005, Lodz

00-013

Investigational Site Number 616008, Warsaw

420-767

Investigational Site Number 410002, Bucheon-si

361-711

Investigational Site Number 410003, Cheongju-si

120-752

Investigational Site Number 410004, Seoul

138-736

Investigational Site Number 410005, Seoul

443-721

Investigational Site Number 410001, Suwon

08025

Investigational Site Number 724005, Barcelona

08035

Investigational Site Number 724002, Barcelona

08036

Investigational Site Number 724001, Barcelona

08208

Investigational Site Number 724003, Sabadell

08830

Investigational Site Number 724007, Sant Boi de Llobregat

06100

Investigational Site Number 792002, Ankara

03049

Investigational Site Number 804004, Kyiv

03680

Investigational Site Number 804003, Kyiv

Investigational Site Number 804008, Kyiv

Investigational Site Number 804018, Kyiv

Investigational Site Number 804020, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY