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 6, 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 (69)

1026

RECRUITING

Investigational Site Number : 3480005, Budapest

1414

RECRUITING

Investigational Site Number : 0320001, Buenos Aires

2153

RECRUITING

Investigational Site Number : 0360003, Bella Vista

3400

RECRUITING

Investigational Site Number : 0320004, Corrientes

4000

RECRUITING

Investigational Site Number : 0320005, San Miguel de Tucumán

4029

RECRUITING

Investigational Site Number : 0360002, Brisbane

5340

RECRUITING

Investigational Site Number : 0560004, Gesves Namur

6163

RECRUITING

Investigational Site Number : 0360001, Spearwood

6720

RECRUITING

Investigational Site Number : 3480001, Szeged

13005

RECRUITING

Investigational Site Number : 2500004, Marseille

16059

RECRUITING

Investigational Site Number : 7920001, Bursa

20132

RECRUITING

Investigational Site Number : 3800001, Milan

28040

RECRUITING

Investigational Site Number : 7240012, Madrid

29650

RECRUITING

Spartanburg Greer ENT & Allergy- Site Number : 8400039, Greer

31008

RECRUITING

Investigational Site Number : 7240008, Pamplona

33076

RECRUITING

Investigational Site Number : 2500011, Bordeaux

34295

RECRUITING

Investigational Site Number : 2500005, Montpellier

34360

RECRUITING

Investigational Site Number : 7920002, Istanbul

34653

RECRUITING

Advanced Research Institute - New Port Richey- Site Number : 8400014, New Port Richey

40207

RECRUITING

Advanced ENT & Allergy- Site Number : 8400007, Louisville

45267

RECRUITING

University of Cincinnati - Internal Medicine- Site Number : 8400022, Cincinnati

70508

RECRUITING

MedPharmics - Lafeyette- Site Number : 8400026, Lafayette

73120

RECRUITING

Allergy, Asthma and Clinical Research- Site Number : 8400002, Oklahoma City

76104

RECRUITING

Ear and Sinus Institute- Site Number : 8400048, Fort Worth

80131

RECRUITING

Investigational Site Number : 3800005, Naples

86021

RECRUITING

Investigational Site Number : 2500010, Poitiers

91942

RECRUITING

San Diego Clinical Research Center- Site Number : 8400041, San Diego

94558

RECRUITING

One of a Kind CLinical Research Center- Site Number : 8400034, Napa

95124

RECRUITING

Investigational Site Number : 3800003, Catania

95300

RECRUITING

Investigational Site Number : 2500014, Pontoise

100730

RECRUITING

Investigational Site Number : 1560001, Beijing

110004

RECRUITING

Investigational Site Number : 1560006, Shenyang

215006

RECRUITING

Investigational Site Number : 1560024, Suzhou

230001

RECRUITING

Investigational Site Number : 1560005, Hefei

250022

RECRUITING

Investigational Site Number : 1560002, Jinan

255036

RECRUITING

Investigational Site Number : 1560009, Zibo

264001

RECRUITING

Investigational Site Number : 1560003, Yantai

310003

RECRUITING

Investigational Site Number : 1560019, Hangzhou

400016

RECRUITING

Investigational Site Number : 1560025, Chongqing

430060

RECRUITING

Investigational Site Number : 1560014, Wuhan

434020

RECRUITING

Investigational Site Number : 1560012, Jingzhou

530021

RECRUITING

Investigational Site Number : 1560021, Nanning

610017

RECRUITING

Investigational Site Number : 1560004, Chengdu

2687000

RECRUITING

Investigational Site Number : 1520004, Talcahuano

4070094

RECRUITING

Investigational Site Number : 1520001, Concepción

7500505

RECRUITING

Investigational Site Number : 1520003, Santiago

9112001

RECRUITING

Investigational Site Number : 3760004, Jerusalem

K1G 6C6

RECRUITING

Investigational Site Number : 1240014, Ottawa

G1V 4W2

RECRUITING

Investigational Site Number : 1240003, Québec

G2J 0C4

RECRUITING

Investigational Site Number : 1240012, Québec

014040

RECRUITING

Investigational Site Number : 1560020, Baotou

030001

RECRUITING

Investigational Site Number : 1560017, Taiyuan

RECRUITING

Investigational Site Number : 1560023, Taiyuan

500 05

RECRUITING

Investigational Site Number : 2030002, Hradec Králové

532 03

RECRUITING

Investigational Site Number : 2030003, Pardubice

305 99

RECRUITING

Investigational Site Number : 2030005, Pilsen

100 34

RECRUITING

Investigational Site Number : 2030004, Prague

150 06

RECRUITING

Investigational Site Number : 2030001, Prague

04103

RECRUITING

Investigational Site Number : 2760002, Leipzig

1081 HV

RECRUITING

Investigational Site Number : 5280002, Amsterdam

90-302

RECRUITING

Investigational Site Number : 6160002, Lodz

43-309

RECRUITING

Investigational Site Number : 6160001, Bielsko-Biala

60-693

RECRUITING

Investigational Site Number : 6160004, Poznan

08003

RECRUITING

Investigational Site Number : 7240006, Barcelona

08907

RECRUITING

Investigational Site Number : 7240004, L'Hospitalet de Llobregat

06100

RECRUITING

Investigational Site Number : 7920003, Ankara

WN6 9EP

RECRUITING

Investigational Site Number : 8260002, Wigan

TA1 5DA

RECRUITING

Investigational Site Number : 8260003, Taunton

W2 1NY

RECRUITING

Investigational Site Number : 8260001, London

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY

NCT06834360 - 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