A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps

PHASE3RecruitingINTERVENTIONAL
Enrollment

210

Participants

Timeline

Start Date

February 12, 2025

Primary Completion Date

January 8, 2027

Study Completion Date

December 13, 2027

Conditions
Chronic Rhinosinusitis With Nasal Polyps
Interventions
DRUG

Itepekimab (SAR440340)

Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous

DRUG

Placebo

Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous

DRUG

Mometasone furoate nasal spray (MFNS)

Pharmaceutical form: Solution for administration via spray pump. Route of administration: Intranasal spray

Trial Locations (93)

1046

RECRUITING

Investigational Site Number : 3480002, Budapest

1090

RECRUITING

Investigational Site Number : 0400001, Vienna

2000

RECRUITING

Investigational Site Number : 0320004, Rosario

4010

RECRUITING

Investigational Site Number : 0400002, Linz

5500

RECRUITING

Investigational Site Number : 0320003, Mendoza

7621

RECRUITING

Investigational Site Number : 3480001, Pécs

8036

RECRUITING

Investigational Site Number : 0400005, Graz

10117

RECRUITING

Investigational Site Number : 2760004, Berlin

11020

RECRUITING

Rheumatology- Site Number : 8400028, Great Neck

11407

RECRUITING

Investigational Site Number : 7240004, Jerez de la Frontera

15706

RECRUITING

Investigational Site Number : 7240003, Santiago de Compostela

20142

RECRUITING

ASST Santi Paolo e Carlo-Presidio Ospedale San Paolo-Site Number : 3800006, Milan

23507

RECRUITING

Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400046, Norfolk

28222

RECRUITING

Investigational Site Number : 7240001, Majadahonda

30303

RECRUITING

Emory University School of Medicine- Grady Campus- Site Number : 8400047, Atlanta

31116

RECRUITING

Investigational Site Number : 4100005, Cheonan

32807

RECRUITING

Orlando ENT Associates - Orlando- Site Number : 8400008, Orlando

33176

RECRUITING

Advanced Research Associates (ARA) Professionals- Site Number : 8400011, Miami

33185

RECRUITING

Paradisus Med Research - Miami- Site Number : 8400009, Miami

34093

RECRUITING

Investigational Site Number : 7920001, Istanbul

34362

RECRUITING

Investigational Site Number : 3760007, Haifa

34865

RECRUITING

Investigational Site Number : 7920002, Istanbul

35128

RECRUITING

Azienda Ospedale - Università Padova-Site Number : 3800008, Padua

41009

RECRUITING

Investigational Site Number : 7240006, Seville

44124

RECRUITING

Azienda Ospedaliero-Universitaria di Ferrara-Site Number: 3800004, Cona (Ferrara)

44281

RECRUITING

Investigational Site Number : 3760004, Kfar Saba

49100

RECRUITING

Investigational Site Number : 3760005, Petah Tikva

50009

RECRUITING

Investigational Site Number : 7240005, Zaragoza

60637

RECRUITING

University of Chicago Medical Center- Site Number : 8400018, Chicago

64239

RECRUITING

Investigational Site Number : 3760009, Tel Aviv

65205

RECRUITING

Investigational Site Number : 2760005, Wiesbaden

70210

RECRUITING

Investigational Site Number : 2460002, Kuopio

72076

RECRUITING

Investigational Site Number : 2760001, Tübingen

75244

RECRUITING

TEN20 Clinical Research - Dallas- Site Number : 8400015, Dallas

90022

RECRUITING

Sensa Health- Site Number : 8400038, Los Angeles

90503

RECRUITING

Breathe Clear Institute of Sinus and Allergy Relief- Site Number : 8400040, Torrance

90505

RECRUITING

Orso Health - Torrance- Site Number : 8400035, Torrance

91006

RECRUITING

University of Southern California (USC) / Keck Medicine of USC- Site Number : 8400037, Arcadia

92663

RECRUITING

Newport Native MD- Site Number : 8400031, Newport Beach

97080

RECRUITING

Investigational Site Number : 2760003, Würzburg

2540488

RECRUITING

Investigational Site Number : 1520005, Viña del Mar

2591193

RECRUITING

Investigational Site Number : 3920009, Isehara

3465584

RECRUITING

Investigational Site Number : 1520003, Talca

5110683

RECRUITING

Investigational Site Number : 1520006, Valdivia

7500692

RECRUITING

Investigational Site Number : 1520002, Santiago

7691236

RECRUITING

Investigational Site Number : 1520004, Santiago

8207257

RECRUITING

Investigational Site Number : 1520001, Santiago

B1900BNN

RECRUITING

Investigational Site Number : 0320002, La Plata

B1602DQD

RECRUITING

Investigational Site Number : 0320005, Vicente Lopez

C1425BEN

RECRUITING

Investigational Site Number : 0320001, Ciudad Autonoma Buenos Aires

14015-010

RECRUITING

Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760002, Ribeirão Preto

12230-001

RECRUITING

Centro Internacional de Pesquisa Clinica - CIPES- Site Number : 0760005, São José dos Campos

N6A 4V2

RECRUITING

Investigational Site Number : 1240005, London

H4A 3J1

RECRUITING

Investigational Site Number : 1240002, Montreal

G1V 4G5

RECRUITING

Investigational Site Number : 1240001, Québec

00130

RECRUITING

Investigational Site Number : 2460003, Helsinki

00250

RECRUITING

Investigational Site Number : 2460004, Helsinki

00168

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Site Number: 3800002, Roma

910-1193

RECRUITING

Investigational Site Number : 3920006, Yoshida-gun

812-0053

RECRUITING

Investigational Site Number : 3920001, Fukuoka

250-8558

RECRUITING

Investigational Site Number : 3920002, Odawara-shi

236-0037

RECRUITING

Investigational Site Number : 3920014, Yokohama

392-8510

RECRUITING

Investigational Site Number : 3920005, Suwa-shi

951-8520

RECRUITING

Investigational Site Number : 3920013, Niigata

525-8585

RECRUITING

Investigational Site Number : 3920012, Kusatsu-shi

734-8530

RECRUITING

Investigational Site Number : 3920011, Hiroshima

860-0814

RECRUITING

Investigational Site Number : 3920003, Kumamoto

1815 JD

RECRUITING

Investigational Site Number : 5280004, Alkmaar

2353 GA

RECRUITING

Investigational Site Number : 5280002, Leiderdorp

53-149

RECRUITING

Investigational Site Number : 6160001, Wroclaw

04-141

RECRUITING

Investigational Site Number : 6160002, Warsaw

15-756

RECRUITING

Investigational Site Number : 6160003, Bialystok

31-513

RECRUITING

Investigational Site Number : 6160006, Krakow

53-301

RECRUITING

Investigational Site Number : 6160004, Wroclaw

3810-501

RECRUITING

Investigational Site Number : 6200002, Aveiro

4810-061

RECRUITING

Investigational Site Number : 6200003, Guimarães

4464-513

RECRUITING

Investigational Site Number : 6200004, Matosinhos Municipality

4520-211

RECRUITING

Investigational Site Number : 6200001, Santa Maria da Feira

03080

RECRUITING

Investigational Site Number : 4100003, Seoul

03722

RECRUITING

Investigational Site Number : 4100004, Seoul

07061

RECRUITING

Investigational Site Number : 4100001, Seoul

135-710

RECRUITING

Investigational Site Number : 4100002, Seoul

08022

RECRUITING

Investigational Site Number : 7240008, Barcelona

08036

RECRUITING

Investigational Site Number : 7240002, Barcelona

08208

RECRUITING

Investigational Site Number : 7240009, Sabadell

221 85

RECRUITING

Investigational Site Number : 7520002, Lund

114 86

RECRUITING

Investigational Site Number : 7520004, Stockholm

171 76

RECRUITING

Investigational Site Number : 7520001, Stockholm

06230

RECRUITING

Investigational Site Number : 7920003, Ankara

OX39DU

RECRUITING

Investigational Site Number : 8260006, Oxford

NE7 7DN

RECRUITING

Investigational Site Number : 8260001, Newcastle upon Tyne

BD9 6RJ

RECRUITING

Investigational Site Number : 8260004, Bradford

NW1 2BU

RECRUITING

Investigational Site Number : 8260002, London

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY

NCT06834347 - A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps | Biotech Hunter | Biotech Hunter