A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Non-cystic Fibrosis Bronchiectasis

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

312

Participants

Timeline

Start Date

February 20, 2024

Primary Completion Date

September 16, 2025

Study Completion Date

February 2, 2026

Conditions
Bronchiectasis
Interventions
DRUG

Itepekimab (SAR440340)

Pharmaceutical form: solution for injection in pre-filled syringe. Route of administration: subcutaneous

DRUG

Placebo

Pharmaceutical form: solution for injection in pre-filled syringe. Route of administration: subcutaneous

Trial Locations (138)

100

Investigational Site Number : 1580004, Taipei

110

Investigational Site Number : 1580003, Taipei

220

Investigational Site Number : 1580002, New Taipei City

404

Investigational Site Number : 1580006, Taichung

807

Investigational Site Number : 1580005, Kaohsiung City

1121

Investigational Site Number : 0320003, Buenos Aires

1280

Investigational Site Number : 0320008, Buenos Aires

1414

Investigational Site Number : 0320001, Buenos Aires

1427

Investigational Site Number : 0320004, Buenos Aires

1900

Investigational Site Number : 0320002, La Plata

4000

Investigational Site Number : 0320005, San Miguel de Tucumán

5000

Investigational Site Number : 2080004, Odense

5003

Investigational Site Number : 0320007, Córdoba

5500

Investigational Site Number : 0320006, Mendoza

7100

Investigational Site Number : 2080001, Vejle

8200

Investigational Site Number : 2080005, Aarhus

9000

Investigational Site Number : 2080002, Aalborg

10016

NYU Langone Medical Center- Site Number : 8400032, New York

12159

Investigational Site Number : 2760010, Berlin

15801

Clinical Research Associates of Central PA - Dubois- Site Number : 8400005, DuBois

17005

Investigational Site Number : 7240012, Girona

19104

Penn Medicine: University of Pennsylvania Health System- Site Number : 8400039, Philadelphia

19140

Temple University Hospital- Site Number : 8400015, Philadelphia

20089

Investigational Site Number : 3800002, Rozzano

20122

Investigational Site Number : 3800001, Milan

22926

Investigational Site Number : 2760001, Ahrensburg

23552

Investigational Site Number : 2760004, Lübeck

27100

Investigational Site Number : 3800003, Pavia

27103

Southeastern Research Center- Site Number : 8400008, Winston-Salem

28007

Investigational Site Number : 7240002, Madrid

28078

Advanced Respiratory and Sleep Medicine - Huntersville- Site Number : 8400009, Huntersville

28277

American Health Research - Charlotte- Site Number : 8400017, Charlotte

29200

Investigational Site Number : 2500005, Brest

29425

Medical University of South Carolina - Charleston - Jonathan Lucas Street- Site Number : 8400027, Charleston

32503

Avanza Medical Research Center- Site Number : 8400018, Pensacola

33070

Investigational Site Number : 7920002, Akdeniz

33126

Clever Medical Research- Site Number : 8400001, Miami

33155

My Community Research Center- Site Number : 8400023, Miami

33157

Destiny Research Center- Site Number : 8400049, Palmetto Bay

33184

High Quality Research- Site Number : 8400047, Miami

33324

Private Practice - Dr. Frank Hull - Plantation- Site Number : 8400010, Plantation

33470

Advanced Pulmonary Research Institute- Site Number : 8400007, Loxahatchee Groves

34090

Investigational Site Number : 2500002, Montpellier

34093

Investigational Site Number : 7920001, Istanbul

35233

University of Alabama at Birmingham- Site Number : 8400040, Birmingham

41001

Investigational Site Number : 7920004, İzmit

42123

Investigational Site Number : 3800006, Reggio Emilia

44800

Investigational Site Number : 2500006, Saint-Herblain

45239

Investigational Site Number : 2760007, Essen

48088

Pulmonary and Medicine Associates- Site Number : 8400057, Warren

48109

University of Michigan Health System - Ann Arbor- Site Number : 8400055, Ann Arbor

55128

Investigational Site Number : 2760002, Mainz

55139

Investigational Site Number : 7920006, Samsun

56170

Investigational Site Number : 2760005, Bendorf

60596

Investigational Site Number : 2760003, Frankfurt

60611

Northwestern Memorial Hospital- Site Number : 8400043, Chicago

63110

Washington University- Site Number : 8400046, St Louis

66160

University of Kansas Medical Center- Site Number : 8400045, Kansas City

69004

Investigational Site Number : 2500001, Lyon

75024

Plano Primary Care Clinic- Site Number : 8400019, Plano

75069

Metroplex Pulmonary and Sleep Center- Site Number : 8400014, McKinney

75679

Investigational Site Number : 2500003, Paris

75708

The University of Texas Health Center at Tyler- Site Number : 8400053, Tyler

77479

Pioneer Research Solutions, Inc.- Site Number : 8400048, Sugar Land

80014

Allianz Research Institute CO- Site Number : 8400038, Aurora

80337

Investigational Site Number : 2760011, Munich

85006

Pulmonary Associates - Phoenix - East McDowell Road- Site Number : 8400012, Phoenix

90048

Southern California Institute for Respiratory Diseases- Site Number : 8400002, Los Angeles

90127

Investigational Site Number : 3800004, Palermo

92120

Institute Healthcare Assessment- Site Number : 8400037, San Diego

92683

Allianz Research Institute- Site Number : 8400013, Westminster

100020

Investigational Site Number : 1560005, Beijing

110004

Investigational Site Number : 1560007, Shenyang

130021

Investigational Site Number : 1560008, Changchun

200025

Investigational Site Number : 1560006, Shanghai

200433

Investigational Site Number : 1560002, Shanghai

221006

Investigational Site Number : 1560003, Xuzhou

510120

Investigational Site Number : 1560001, Guangzhou

610041

Investigational Site Number : 1560004, Chengdu

2260877

Investigational Site Number : 1520004, Quillota

3436212

Investigational Site Number : 3760006, Haifa

3465584

Investigational Site Number : 1520001, Talca

4941492

Investigational Site Number : 3760002, Petah Tikva

5262100

Investigational Site Number : 3760009, Ramat Gan

6423906

Investigational Site Number : 3760007, Tel Aviv

6789140

Investigational Site Number : 3760010, Tel Aviv

7500587

Investigational Site Number : 1520003, Santiago

7500692

Investigational Site Number : 1520002, Santiago

7610001

Investigational Site Number : 3760004, Rehovot

7830604

Investigational Site Number : 3760008, Ashkelon

9103102

Investigational Site Number : 3760003, Jerusalem

9112001

Investigational Site Number : 3760001, Jerusalem

06032

University of Connecticut Health Center- Site Number : 8400020, Farmington

06510

Yale New Haven Hospital- Site Number : 8400065, New Haven

38411-186

Oncoclínicas UMC- Site Number : 0760007, Uberlândia

90020-090

Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760005, Porto Alegre

90610-000

Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001, Porto Alegre

91010-006

WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760004, Porto Alegre

05403-900

Incor - Instituto do Coracao- Site Number : 0760002, São Paulo

N1H 6J2

Investigational Site Number : 1240003, Guelph

J1H 5N4

Investigational Site Number : 1240005, Sherbrooke

G8T 7A1

Investigational Site Number : 1240001, Trois-Rivières

381 01

Investigational Site Number : 2030006, Český Krumlov

377 01

Investigational Site Number : 2030002, Jindřichův Hradec

278 01

Investigational Site Number : 2030004, Kralupy nad Vltavou

305 99

Investigational Site Number : 2030003, Pilsen

190 00

Investigational Site Number : 2030005, Prague

06001

Investigational Site Number : 2500004, Nice

03050

Investigational Site Number : 2760009, Cottbus

455 00

Investigational Site Number : 3000001, Ioannina

570 10

Investigational Site Number : 3000003, Thessaloniki

296-0041

Investigational Site Number : 3920002, Kamogawa

670-0849

Investigational Site Number : 3920004, Himeji

204-8522

Investigational Site Number : 3920005, Kiyose

140-8522

Investigational Site Number : 3920001, Tokyo

162-8655

Investigational Site Number : 3920003, Tokyo

1815 JD

Investigational Site Number : 5280002, Alkmaar

1105 AZ

Investigational Site Number : 5280005, Amsterdam

4818 CK

Investigational Site Number : 5280004, Breda

3015 CE

Investigational Site Number : 5280001, Rotterdam

2545 CH

Investigational Site Number : 5280003, The Hague

90-153

Investigational Site Number : 6160005, Lodz

15-044

Investigational Site Number : 6160001, Bialystok

90-302

Investigational Site Number : 6160003, Lodz

84-200

Investigational Site Number : 6160006, Wejherowo

27-400

Investigational Site Number : 6160002, Ostrowiec Świętokrzyski

08017

Investigational Site Number : 7240007, Barcelona

08035

Investigational Site Number : 7240003, Barcelona

08036

Investigational Site Number : 7240006, Barcelona

08907

Investigational Site Number : 7240001, L'Hospitalet de Llobregat

01330

Investigational Site Number : 7920003, Adana

06620

Investigational Site Number : 7920005, Ankara

CB23 3RE

Investigational Site Number : 8260009, Cambridge

NR4 7UY

Investigational Site Number : 8260008, Norwich

NE29 8NH

Investigational Site Number : 8260003, North Shields

LA1 4RP

Investigational Site Number : 8260004, Lancaster

NE7 7DN

Investigational Site Number : 8260001, Newcastle upon Tyne

RG1 5AN

Investigational Site Number : 8260005, Reading

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY