A Controlled Clinical Study of Dupilumab in Patients With Bilateral Nasal Polyps

PHASE3CompletedINTERVENTIONAL
Enrollment

276

Participants

Timeline

Start Date

December 5, 2016

Primary Completion Date

July 5, 2018

Study Completion Date

July 5, 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 50 micrograms

"Pharmaceutical form: Suspension (Nasal spray)~Route of administration: Intranasal"

Trial Locations (76)

1062

Investigational Site Number 3480006, Budapest

1083

Investigational Site Number 3480007, Budapest

1115

Investigational Site Number 3480004, Budapest

1125

Investigational Site Number 3480003, Budapest

1527

Investigational Site Number 1000002, Sofia

1606

Investigational Site Number 1000001, Sofia

4002

Investigational Site Number 1000003, Plovdiv

4032

Investigational Site Number 3480005, Debrecen

6725

Investigational Site Number 3480001, Szeged

7621

Investigational Site Number 3480002, Pécs

12808

Investigational Site Number 2030004, Prague

13353

Investigational Site Number 2760001, Berlin

20089

Investigational Site Number 3800005, Rozzano

20132

Investigational Site Number 3800004, Milan

20142

Investigational Site Number 3800006, Milan

21100

Investigational Site Number 3800003, Varese

23507

Investigational Site Number 8400015, Norfolk

27103

Investigational Site Number 8400008, Winston-Salem

29425

Investigational Site Number 8400018, Charleston

31059

Investigational Site Number 2500002, Toulouse

33613

Investigational Site Number 8400013, Tampa

34000

Investigational Site Number 2500001, Montpellier

36011

Investigational Site Number 8040001, Poltava

40139

Investigational Site Number 3800007, Bologna

44035

Investigational Site Number 2500006, Nantes

46000

Investigational Site Number 8040008, Ternopil

48149

Investigational Site Number 2760002, Münster

50005

Investigational Site Number 2030001, Hradec Králové

50265

Investigational Site Number 8400022, West Des Moines

53203

Investigational Site Number 2030002, Pardubice

53226

Investigational Site Number 8400010, Milwaukee

54511

Investigational Site Number 2500004, Vandœuvre-lès-Nancy

55905

Investigational Site Number 8400005, Rochester

56124

Investigational Site Number 3800001, Pisa

59000

Investigational Site Number 2500007, Lille

61166

Investigational Site Number 8040004, Kharkiv

63141

Investigational Site Number 8400021, St Louis

69317

Investigational Site Number 2500003, Lyon

74136

Investigational Site Number 8400019, Tulsa

75231

Investigational Site Number 8400001, Dallas

76000

Investigational Site Number 8040002, Ivano-Frankivsk

80112

Investigational Site Number 8400016, Centennial

81377

Investigational Site Number 2760003, München

85925

Investigational Site Number 2500005, La Roche-sur-Yon

90720

Investigational Site Number 8400009, Long Beach

92123

Investigational Site Number 8400014, San Diego

92868

Investigational Site Number 8400004, Orange

95123

Investigational Site Number 3800002, Catania

95207

Investigational Site Number 8400002, Stockton

97504

Investigational Site Number 8400020, Medford

119435

Investigational Site Number 6430004, Moscow

129090

Investigational Site Number 6430003, Moscow

150003

Investigational Site Number 6430006, Yaroslavl

190013

Investigational Site Number 6430002, Saint Petersburg

195030

Investigational Site Number 6430001, Saint Petersburg

197022

Investigational Site Number 6430007, Saint Petersburg

200642

Investigational Site Number 6420008, Craiova

400015

Investigational Site Number 6420009, Cluj-Napoca

500283

Investigational Site Number 6420007, Brasov

Investigational Site Number 6420013, Brasov

540098

Investigational Site Number 6420010, Târgu Mureş

02115

Investigational Site Number 8400007, Boston

37232-8695

Investigational Site Number 8400003, Nashville

1105 AZ

Investigational Site Number 5280001, Amsterdam

40-611

Investigational Site Number 6160002, Katowice

90-153

Investigational Site Number 6160001, Lodz

04-141

Investigational Site Number 6160003, Warsaw

011172

Investigational Site Number 6420003, Bucharest

01133

Investigational Site Number 8040005, Kyiv

03680

Investigational Site Number 8040006, Kyiv

BD9 6RJ

Investigational Site Number 8260001, Bradford

DD1 9SY

Investigational Site Number 8260002, Dundee

NR31 6LA

Investigational Site Number 8260007, Great Yarmouth

SE1 7EH

Investigational Site Number 8260006, London

SK2 7JE

Investigational Site Number 8260004, Stockport

WN1 2NN

Investigational Site Number 8260005, Wigan

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY