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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
Sponsor: Sanofi
Summary
ACT18018 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study with 3 treatment groups. The purpose of this study was to evaluate efficacy, safety and tolerability with 2 dosing regimens of itepekimab compared with placebo in male and/or female participants with NCFB aged 18 years of age up to 85 years of age (inclusive). Study details include: * The study duration (screening, 24-52-week treatment, 20-week safety follow-up) was up to 47-77 weeks * The treatment duration was up to 24-52 weeks * The follow-up duration was 20 weeks * Site/phone visits were at a monthly interval
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof-of-Concept (PoC) Study to Assess the Efficacy, Safety and Tolerability of Itepekimab, in Participants With Non-cystic Fibrosis Bronchiectasis
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
314
Start Date
2024-02-20
Completion Date
2026-02-02
Last Updated
2026-10-07
Healthy Volunteers
No
Conditions
Interventions
Itepekimab (SAR440340)
* Pharmaceutical form: solution for injection in pre-filled syringe * Route of administration: subcutaneous
Placebo
* Pharmaceutical form: solution for injection in pre-filled syringe * Route of administration: subcutaneous
Locations (117)
Pulmonary Associates - Phoenix - East McDowell Road- Site Number : 8400012
Phoenix, Arizona, United States
Southern California Institute for Respiratory Diseases- Site Number : 8400002
Los Angeles, California, United States
Allianz Research Institute- Site Number : 8400013
Westminster, California, United States
Allianz Research Institute CO- Site Number : 8400038
Aurora, Colorado, United States
University of Connecticut Health Center- Site Number : 8400020
Farmington, Connecticut, United States
Yale New Haven Hospital- Site Number : 8400065
New Haven, Connecticut, United States
Advanced Pulmonary Research Institute- Site Number : 8400007
Loxahatchee Groves, Florida, United States
High Quality Research- Site Number : 8400047
Miami, Florida, United States
Avanza Medical Research Center- Site Number : 8400018
Pensacola, Florida, United States
Private Practice - Dr. Frank Hull - Plantation- Site Number : 8400010
Plantation, Florida, United States
Northwestern Memorial Hospital- Site Number : 8400043
Chicago, Illinois, United States
University of Kansas Medical Center- Site Number : 8400045
Kansas City, Kansas, United States
University of Michigan Health System - Ann Arbor- Site Number : 8400055
Ann Arbor, Michigan, United States
Pulmonary and Medicine Associates- Site Number : 8400057
Warren, Michigan, United States
Washington University- Site Number : 8400046
St Louis, Missouri, United States
NYU Langone Medical Center- Site Number : 8400032
New York, New York, United States
Southeastern Research Center- Site Number : 8400008
Winston-Salem, North Carolina, United States
Clinical Research Associates of Central PA - Dubois- Site Number : 8400005
DuBois, Pennsylvania, United States
Penn Medicine: University of Pennsylvania Health System- Site Number : 8400039
Philadelphia, Pennsylvania, United States
Medical University of South Carolina - Charleston - Jonathan Lucas Street- Site Number : 8400027
Charleston, South Carolina, United States
Metroplex Pulmonary and Sleep Center- Site Number : 8400014
McKinney, Texas, United States
Pioneer Research Solutions, Inc.- Site Number : 8400048
Sugar Land, Texas, United States
The University of Texas Health Center at Tyler- Site Number : 8400053
Tyler, Texas, United States
Investigational Site Number : 0320003
Buenos Aires, Argentina
Investigational Site Number : 0320008
Buenos Aires, Argentina
Investigational Site Number : 0320001
Buenos Aires, Argentina
Investigational Site Number : 0320007
Córdoba, Argentina
Investigational Site Number : 0320006
Mendoza, Argentina
Investigational Site Number : 0320005
San Miguel de Tucumán, Argentina
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001
Porto Alegre, Rio Grande do Sul, Brazil
WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760004
Porto Alegre, Rio Grande do Sul, Brazil
Incor - Instituto do Coracao- Site Number : 0760002
São Paulo, Brazil
Investigational Site Number : 1240003
Guelph, Ontario, Canada
Investigational Site Number : 1240005
Sherbrooke, Quebec, Canada
Investigational Site Number : 1240001
Trois-Rivières, Quebec, Canada
Investigational Site Number : 1520001
Talca, Maule Region, Chile
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520004
Quillota, Valparaiso, Chile
Investigational Site Number : 1560005
Beijing, China
Investigational Site Number : 1560008
Changchun, China
Investigational Site Number : 1560004
Chengdu, China
Investigational Site Number : 1560001
Guangzhou, China
Investigational Site Number : 1560007
Shenyang, China
Investigational Site Number : 1560003
Xuzhou, China
Investigational Site Number : 2030006
Český Krumlov, Czechia
Investigational Site Number : 2030002
Jindřichův Hradec, Czechia
Investigational Site Number : 2030004
Kralupy nad Vltavou, Czechia
Investigational Site Number : 2030003
Pilsen, Czechia
Investigational Site Number : 2030005
Prague, Czechia
Investigational Site Number : 2080002
Aalborg, Denmark
Investigational Site Number : 2080005
Aarhus, Denmark
Investigational Site Number : 2080004
Odense, Denmark
Investigational Site Number : 2080001
Vejle, Denmark
Investigational Site Number : 2500005
Brest, France
Investigational Site Number : 2500001
Lyon, France
Investigational Site Number : 2500002
Montpellier, France
Investigational Site Number : 2500004
Nice, France
Investigational Site Number : 2500003
Paris, France
Investigational Site Number : 2500006
Saint-Herblain, France
Investigational Site Number : 2760005
Bendorf, Germany
Investigational Site Number : 2760010
Berlin, Germany
Investigational Site Number : 2760007
Essen, Germany
Investigational Site Number : 2760003
Frankfurt, Germany
Investigational Site Number : 2760004
Lübeck, Germany
Investigational Site Number : 2760011
Munich, Germany
Investigational Site Number : 3000001
Ioannina, Greece
Investigational Site Number : 3000003
Thessaloniki, Greece
Investigational Site Number : 3760008
Ashkelon, Israel
Investigational Site Number : 3760006
Haifa, Israel
Investigational Site Number : 3760003
Jerusalem, Israel
Investigational Site Number : 3760001
Jerusalem, Israel
Investigational Site Number : 3760002
Petah Tikva, Israel
Investigational Site Number : 3760009
Ramat Gan, Israel
Investigational Site Number : 3760004
Rehovot, Israel
Investigational Site Number : 3760007
Tel Aviv, Israel
Investigational Site Number : 3760010
Tel Aviv, Israel
Investigational Site Number : 3800001
Milan, Lombardy, Italy
Investigational Site Number : 3800002
Rozzano, Milano, Italy
Investigational Site Number : 3800004
Palermo, Italy
Investigational Site Number : 3800003
Pavia, Italy
Investigational Site Number : 3800006
Reggio Emilia, Italy
Investigational Site Number : 3920002
Kamogawa, Chiba, Japan
Investigational Site Number : 3920004
Himeji, Hyōgo, Japan
Investigational Site Number : 3920005
Kiyose, Tokyo, Japan
Investigational Site Number : 3920001
Tokyo, Japan
Investigational Site Number : 3920003
Tokyo, Japan
Investigational Site Number : 5280002
Alkmaar, Netherlands
Investigational Site Number : 5280005
Amsterdam, Netherlands
Investigational Site Number : 5280004
Breda, Netherlands
Investigational Site Number : 5280001
Rotterdam, Netherlands
Investigational Site Number : 5280003
The Hague, Netherlands
Investigational Site Number : 6160005
Lodz, Lódzkie, Poland
Investigational Site Number : 6160001
Bialystok, Podlaskie Voivodeship, Poland
Investigational Site Number : 6160002
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland
Investigational Site Number : 7240007
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240003
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240006
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240001
L'Hospitalet de Llobregat, Barcelona [Barcelona], Spain
Investigational Site Number : 7240012
Girona, Girona [Gerona], Spain