Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps

PHASE3CompletedINTERVENTIONAL
Enrollment

448

Participants

Timeline

Start Date

November 28, 2016

Primary Completion Date

August 27, 2018

Study Completion Date

November 16, 2018

Conditions
Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)
Interventions
DRUG

Dupilumab SAR231893 (REGN668)

"Pharmaceutical form: Solution~Route of administration: Subcutaneous"

DRUG

Placebo

"Pharmaceutical form: Solution~Route of administration: Subcutaneous"

DRUG

Mometasone furoate nasal spray

"Pharmaceutical form: Suspension~Route of administration: Intranasal"

Trial Locations (123)

1200

Investigational Site Number 0560003, Brussels

3004

Investigational Site Number 0360003, Prahran

3050

Investigational Site Number 0360001, Parkville

3168

Investigational Site Number 0360002, Clayton

3500

Investigational Site Number 0560002, Leuven

4029

Investigational Site Number 0360004, Herston

5500

Investigational Site Number 0320003, Mendoza

6150

Investigational Site Number 0360005, Murdoch

9000

Investigational Site Number 0560001, Ghent

10461

Investigational Site Number 8400024, The Bronx

11407

Investigational Site Number 7240003, Jerez de la Frontera

15213

Investigational Site Number 8400003, Pittsburgh

16059

Investigational Site Number 7920013, Bursa

18017

Investigational Site Number 8400013, Bethlehem

19104

Investigational Site Number 8400005, Philadelphia

22100

Investigational Site Number 3760003, Nahariya

28040

Investigational Site Number 7240002, Madrid

29420

Investigational Site Number 8400016, North Charleston

31000

Investigational Site Number 4840001, Chihuahua City

31200

Investigational Site Number 4840005, Chihuahua City

34010

Investigational Site Number 7920010, Istanbul

34080

Investigational Site Number 4840004, Durango

34360

Investigational Site Number 7920009, Istanbul

34373

Investigational Site Number 7920003, Istanbul

34390

Investigational Site Number 7920001, Istanbul

34764

Investigational Site Number 7920002, Istanbul

35100

Investigational Site Number 7920006, Izmir

35209

Investigational Site Number 8400019, Birmingham

35340

Investigational Site Number 7920007, Izmir

38100

Investigational Site Number 3760001, Hadera

40207

Investigational Site Number 8400002, Louisville

41071

Investigational Site Number 7240007, Seville

44100

Investigational Site Number 4840002, Guadalajara

46026

Investigational Site Number 7240009, Valencia

49100

Investigational Site Number 3760002, Petah Tikva

52621

Investigational Site Number 3760004, Tel Litwinsky

53100

Investigational Site Number 7920011, Rize

53219

Investigational Site Number 8400007, Milwaukee

64114

Investigational Site Number 8400014, Kansas City

64460

Investigational Site Number 4840003, Monterrey

76100

Investigational Site Number 3760005, Rehovot

80230

Investigational Site Number 8400006, Denver

80909

Investigational Site Number 8400017, Colorado Springs

84132

Investigational Site Number 8400009, Salt Lake City

90274

Investigational Site Number 8400004, Rolling Hills Estates

92647

Investigational Site Number 8400008, Huntington Beach

93720

Investigational Site Number 8400011, Fresno

94598

Investigational Site Number 8400012, Walnut Creek

98225

Investigational Site Number 8400010, Bellevue

123182

Investigational Site Number 6430006, Moscow

143005

Investigational Site Number 6430003, Odintsovo

150062

Investigational Site Number 6430001, Yaroslavl

197022

Investigational Site Number 6430002, Saint Petersburg

355030

Investigational Site Number 6430005, Stavropol

2260877

Investigational Site Number 1520009, Quillota

7500010

Investigational Site Number 1520005, Santiago

7500571

Investigational Site Number 1520011, Santiago

7500692

Investigational Site Number 1520008, Santiago

7980378

Investigational Site Number 1520006, Santiago

8207257

Investigational Site Number 1520001, Santiago

8910131

Investigational Site Number 1520014, Santiago

06519

Investigational Site Number 8400022, New Haven

02114

Investigational Site Number 8400021, Boston

B1602DQD

Investigational Site Number 0320006, Buenos Aires

C1121ABE

Investigational Site Number 0320004, Buenos Aires

C1414AIF

Investigational Site Number 0320005, Caba

C1425BEN

Investigational Site Number 0320001, Caba

C1426ABP

Investigational Site Number 0320007, Caba

S2000DBS

Investigational Site Number 0320008, Rosario

T4000IAR

Investigational Site Number 0320002, San Miguel de Tucumán

K7L 2V7

Investigational Site Number 1240007, Kingston

H2W 1T8

Investigational Site Number 1240002, Montreal

H4A 3J1

Investigational Site Number 1240006, Montreal

K1G 6C6

Investigational Site Number 1240005, Ottawa

G1V 4G5

Investigational Site Number 1240003, Québec

G1V 4W2

Investigational Site Number 1240004, Québec

G8T 7A1

Investigational Site Number 1240008, Trois-Rivières

V5Z 1M9

Investigational Site Number 1240001, Vancouver

Unknown

Investigational Site Number 1520010, San Fernando

Investigational Site Number 1520003, Talca

Investigational Site Number 1520007, Viña del Mar

Investigational Site Number 3920004, Bunkyō City

Investigational Site Number 3920009, Bunkyō City

Investigational Site Number 3920026, Bunkyō City

Investigational Site Number 3920006, Chiyoda-Ku

Investigational Site Number 3920024, Fukuoka

Investigational Site Number 3920010, Hirakata-Shi

Investigational Site Number 3920011, Hiroshima

Investigational Site Number 3920007, Iida-Shi

Investigational Site Number 3920015, Inzai-Shi

Investigational Site Number 3920012, Itabashi-Ku

Investigational Site Number 3920014, Izumisano

Investigational Site Number 3920016, Kawasaki-Shi

Investigational Site Number 3920020, Kitakyushu-Shi

Investigational Site Number 3920027, Kitakyushu-Shi

Investigational Site Number 3920002, Kumamoto

Investigational Site Number 3920021, Kumamoto

Investigational Site Number 3920003, Kyoto

Investigational Site Number 3920023, Meguro-Ku

Investigational Site Number 3920013, Moriguchi-Shi

Investigational Site Number 3920025, Okayama

Investigational Site Number 3920018, Osaka

Investigational Site Number 3920017, Ōta-ku

Investigational Site Number 3920005, Sendai

Investigational Site Number 3920022, Sendai

Investigational Site Number 3920001, Shimonoseki-Shi

Investigational Site Number 3920029, Shinagawa-Ku

Investigational Site Number 3920030, Shinjyuku-Ku

Investigational Site Number 3920028, Takatsuki-Shi

Investigational Site Number 3920019, Yoshida-Gun

3810-501

Investigational Site Number 6200004, Aveiro

4810-061

Investigational Site Number 6200006, Guimarães

1349-019

Investigational Site Number 6200002, Lisbon

4460-188

Investigational Site Number 6200007, Matosinhos Municipality

4099-001

Investigational Site Number 6200001, Porto

4901-858

Investigational Site Number 6200005, Viana do Castelo

08036

Investigational Site Number 7240001, Barcelona

08041

Investigational Site Number 7240006, Barcelona

221 85

Investigational Site Number 7520002, Lund

171 76

Investigational Site Number 7520001, Stockholm

06100

Investigational Site Number 7920004, Ankara

06500

Investigational Site Number 7920005, Ankara

06520

Investigational Site Number 7920008, Ankara

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY