A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti--IL-33 mAb) in Participants With Chronic Rhinosinusitis Without Nasal Polyps

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

December 16, 2024

Primary Completion Date

August 7, 2026

Study Completion Date

February 9, 2027

Conditions
Chronic Rhinosinusitis Without 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 (56)

1200

RECRUITING

Investigational Site Number : 0560003, Brussels

1425

RECRUITING

Investigational Site Number : 0320001, Buenos Aires

3000

RECRUITING

Investigational Site Number : 0560001, Leuven

3400

RECRUITING

Investigational Site Number : 0320004, Corrientes

4000

RECRUITING

Investigational Site Number : 0320003, San Miguel de Tucumán

5340

RECRUITING

Investigational Site Number : 0560004, Gesves Namur

9000

RECRUITING

Investigational Site Number : 0560002, Ghent

11407

RECRUITING

Investigational Site Number : 7240004, Jerez de la Frontera

13005

RECRUITING

Investigational Site Number : 2500004, Marseille

17019

RECRUITING

Investigational Site Number : 2500012, La Rochelle

28040

RECRUITING

Investigational Site Number : 7240006, Madrid

31008

RECRUITING

Investigational Site Number : 7240005, Pamplona

31116

RECRUITING

Investigational Site Number : 4100005, Cheonan-si

33176

RECRUITING

Advanced Research Associates (ARA) Professionals- Site Number : 8400002, Miami

34295

RECRUITING

Investigational Site Number : 2500005, Montpellier

35209

RECRUITING

Alabama Allergy & Asthma Center - Birmingham - Brookwood Boulevard- Site Number : 8400006, Birmingham

41009

RECRUITING

Investigational Site Number : 7240001, Seville

56124

RECRUITING

Azienda Ospedaliero-Universitaria Pisana-Site Number : 3800003, Pisa

75070

RECRUITING

ENT Associates of Texas - McKinne- Site Number : 8400013, McKinney

78258

RECRUITING

Alamo ENT Associates- Site Number : 8400026, San Antonio

80033

RECRUITING

Western States Clinical Research- Site Number : 8400009, Wheat Ridge

83706

RECRUITING

Treasure Valley Medical Research- Site Number : 8400022, Boise

86021

RECRUITING

Investigational Site Number : 2500010, Poitiers

92037

RECRUITING

Modena Allergy + Asthma- Site Number : 8400005, La Jolla

92563

RECRUITING

United Gastroenterologists - Murrieta- Site Number : 8400001, Murrieta

95661

RECRUITING

Sacramento Ear Nose & Throat - Roseville- Site Number : 8400008, Roseville

100730

RECRUITING

Investigational Site Number : 1560001, Beijing

200127

RECRUITING

Investigational Site Number : 1560002, Shanghai

255036

RECRUITING

Investigational Site Number : 1560003, Zibo

500283

RECRUITING

Investigational Site Number : 6420001, Brasov

4070094

RECRUITING

Investigational Site Number : 1520002, Concepción

7500505

RECRUITING

Investigational Site Number : 1520001, Santiago

7500692

RECRUITING

Investigational Site Number : 1520003, Santiago

N6A 4V2

RECRUITING

Investigational Site Number : 1240005, London

H4A 3J1

RECRUITING

Investigational Site Number : 1240002, Montreal

G1V 4G5

RECRUITING

Investigational Site Number : 1240001, Québec

G1V 4W2

RECRUITING

Investigational Site Number : 1240003, Québec

G2J 0C4

RECRUITING

Investigational Site Number : 1240012, Québec

G8T 7A1

RECRUITING

Investigational Site Number : 1240009, Trois-Rivières

014040

RECRUITING

Investigational Site Number : 1560004, Baotou

00128

RECRUITING

Fondazione Policlinico Universitario Campus Bio-Medico-Site Number : 3800002, Roma

00168

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Site Number : 3800001, Roma

90-302

RECRUITING

Investigational Site Number : 6160008, Lodz

00-909

RECRUITING

Investigational Site Number : 6160001, Warsaw

43-309

RECRUITING

Investigational Site Number : 6160004, Bielsko-Biala

31-513

RECRUITING

Investigational Site Number : 6160006, Krakow

60-693

RECRUITING

Investigational Site Number : 6160002, Poznan

4800-055

RECRUITING

Investigational Site Number : 6200001, Guimarães

3814-501

RECRUITING

Investigational Site Number : 6200002, Porto

022238

RECRUITING

Investigational Site Number : 6420002, Bucharest

03080

RECRUITING

Investigational Site Number : 4100003, Seoul

03722

RECRUITING

Investigational Site Number : 4100004, Seoul

06351

RECRUITING

Investigational Site Number : 4100002, Seoul

07061

RECRUITING

Investigational Site Number : 4100001, Seoul

08003

RECRUITING

Investigational Site Number : 7240003, Barcelona

08907

RECRUITING

Investigational Site Number : 7240002, L'Hospitalet de Llobregat

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY

NCT06691113 - A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti--IL-33 mAb) in Participants With Chronic Rhinosinusitis Without Nasal Polyps | Biotech Hunter | Biotech Hunter