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New drug aims to cut dangerous lung Flare-Ups in bronchiectasis patients

NCT ID NCT06280391

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called itepekimab in 312 adults with bronchiectasis (a lung condition causing chronic cough and infections). The goal was to see if it could reduce the number of moderate or severe lung flare-ups compared to a placebo. Participants received either the drug or a placebo for up to a year, with monthly check-ins. The study is complete, and results will show if itepekimab helps control the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

312 people

The number who actually took part.

Started

Feb 2024

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant must be 18 to 85 years of age inclusive. * Clinical history consistent with NCFB (cough, chronic sputum production and/or recurrent respiratory infections). * Participants with a FEV1 % predicted ≥30%. * Participants with at least 2 moderate or 1 severe Pulmonary exacerbations (PEs) in the past 12 months. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Have bronchiectasis due to CF, hypogammaglobulinemia, common variable immunodeficiency, known active nontuberculous mycobacteria (NTM) lung infection, or pulmonary fibrosis. * Known or suspected immunodeficiency disorder. * Pulmonary exacerbation which has not resolved clinically during screening period. * Have significant haemoptysis. * Have any clinically significant abnormal laboratory values at Screening or diseases or disorders. * History of lung transplantation. * History of malignancy within 5 years before Screening, or during the screening period * Currently being treated with antimicrobial therapy for tuberculosis (TB). * Currently on active treatment for allergic bronchopulmonary aspergillosis (ABPA). * Participants with active autoimmune disease or participants using immunosuppressive therapy for autoimmune disease * Known allergy to itepekimab or to excipients * Live-attenuated vaccine(s) within 4 weeks prior to Screening or plans to receive such vaccines during the study * Unstable ischemic heart disease * Cardiomyopathy or other relevant cardiovascular disorder * Clinically significant new abnormal electrocardiogram (ECG) within 6 months prior to, or at Screening * History of human immunodeficiency virus (HIV) infection or positive HIV 1/2 serology at Screening. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

bronchiectasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bronchiectasis

Contacts and locations

Locations

  • Advanced Pulmonary Research Institute- Site Number : 8400007

    Loxahatchee Groves, Florida, 33470, United States

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

    Huntersville, North Carolina, 28078, United States

  • Allianz Research Institute CO- Site Number : 8400038

    Aurora, Colorado, 80014, United States

  • Allianz Research Institute- Site Number : 8400013

    Westminster, California, 92683, United States

  • American Health Research - Charlotte- Site Number : 8400017

    Charlotte, North Carolina, 28277, United States

  • Avanza Medical Research Center- Site Number : 8400018

    Pensacola, Florida, 32503, United States

  • Clever Medical Research- Site Number : 8400001

    Miami, Florida, 33126, United States

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

    DuBois, Pennsylvania, 15801, United States

  • Destiny Research Center- Site Number : 8400049

    Palmetto Bay, Florida, 33157, United States

  • High Quality Research- Site Number : 8400047

    Miami, Florida, 33184, United States

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

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Incor - Instituto do Coracao- Site Number : 0760002

    São Paulo, 05403-900, Brazil

  • Institute Healthcare Assessment- Site Number : 8400037

    San Diego, California, 92120, United States

  • Investigational Site Number : 0320001

    Buenos Aires, 1414, Argentina

  • Investigational Site Number : 0320002

    La Plata, Buenos Aires, 1900, Argentina

  • Investigational Site Number : 0320003

    Buenos Aires, 1121, Argentina

  • Investigational Site Number : 0320004

    Buenos Aires, 1427, Argentina

  • Investigational Site Number : 0320005

    San Miguel de Tucumán, 4000, Argentina

  • Investigational Site Number : 0320006

    Mendoza, 5500, Argentina

  • Investigational Site Number : 0320007

    Córdoba, 5003, Argentina

  • Investigational Site Number : 0320008

    Buenos Aires, 1280, Argentina

  • Investigational Site Number : 1240001

    Trois-Rivières, Quebec, G8T 7A1, Canada

  • Investigational Site Number : 1240003

    Guelph, Ontario, N1H 6J2, Canada

  • Investigational Site Number : 1240005

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Investigational Site Number : 1520001

    Talca, Maule Region, 3465584, Chile

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 7500692, Chile

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 7500587, Chile

  • Investigational Site Number : 1520004

    Quillota, Valparaiso, 2260877, Chile

  • Investigational Site Number : 1560001

    Guangzhou, 510120, China

  • Investigational Site Number : 1560002

    Shanghai, 200433, China

  • Investigational Site Number : 1560003

    Xuzhou, 221006, China

  • Investigational Site Number : 1560004

    Chengdu, 610041, China

  • Investigational Site Number : 1560005

    Beijing, 100020, China

  • Investigational Site Number : 1560006

    Shanghai, 200025, China

  • Investigational Site Number : 1560007

    Shenyang, 110004, China

  • Investigational Site Number : 1560008

    Changchun, 130021, China

  • Investigational Site Number : 1580002

    New Taipei City, 220, Taiwan

  • Investigational Site Number : 1580003

    Taipei, 110, Taiwan

  • Investigational Site Number : 1580004

    Taipei, 100, Taiwan

  • Investigational Site Number : 1580005

    Kaohsiung City, 807, Taiwan

  • Investigational Site Number : 1580006

    Taichung, 404, Taiwan

  • Investigational Site Number : 2030002

    Jindřichův Hradec, 377 01, Czechia

  • Investigational Site Number : 2030003

    Pilsen, 305 99, Czechia

  • Investigational Site Number : 2030004

    Kralupy nad Vltavou, 278 01, Czechia

  • Investigational Site Number : 2030005

    Prague, 190 00, Czechia

  • Investigational Site Number : 2030006

    Český Krumlov, 381 01, Czechia

  • Investigational Site Number : 2080001

    Vejle, 7100, Denmark

  • Investigational Site Number : 2080002

    Aalborg, 9000, Denmark

  • Investigational Site Number : 2080004

    Odense, 5000, Denmark

  • Investigational Site Number : 2080005

    Aarhus, 8200, Denmark

  • Investigational Site Number : 2500001

    Lyon, 69004, France

  • Investigational Site Number : 2500002

    Montpellier, 34090, France

  • Investigational Site Number : 2500003

    Paris, 75679, France

  • Investigational Site Number : 2500004

    Nice, 06001, France

  • Investigational Site Number : 2500005

    Brest, 29200, France

  • Investigational Site Number : 2500006

    Saint-Herblain, 44800, France

  • Investigational Site Number : 2760001

    Ahrensburg, 22926, Germany

  • Investigational Site Number : 2760002

    Mainz, 55128, Germany

  • Investigational Site Number : 2760003

    Frankfurt, 60596, Germany

  • Investigational Site Number : 2760004

    Lübeck, 23552, Germany

  • Investigational Site Number : 2760005

    Bendorf, 56170, Germany

  • Investigational Site Number : 2760007

    Essen, 45239, Germany

  • Investigational Site Number : 2760009

    Cottbus, 03050, Germany

  • Investigational Site Number : 2760010

    Berlin, 12159, Germany

  • Investigational Site Number : 2760011

    Munich, 80337, Germany

  • Investigational Site Number : 3000001

    Ioannina, 455 00, Greece

  • Investigational Site Number : 3000003

    Thessaloniki, 570 10, Greece

  • Investigational Site Number : 3760001

    Jerusalem, 9112001, Israel

  • Investigational Site Number : 3760002

    Petah Tikva, 4941492, Israel

  • Investigational Site Number : 3760003

    Jerusalem, 9103102, Israel

  • Investigational Site Number : 3760004

    Rehovot, 7610001, Israel

  • Investigational Site Number : 3760006

    Haifa, 3436212, Israel

  • Investigational Site Number : 3760007

    Tel Aviv, 6423906, Israel

  • Investigational Site Number : 3760008

    Ashkelon, 7830604, Israel

  • Investigational Site Number : 3760009

    Ramat Gan, 5262100, Israel

  • Investigational Site Number : 3760010

    Tel Aviv, 6789140, Israel

  • Investigational Site Number : 3800001

    Milan, Lombardy, 20122, Italy

  • Investigational Site Number : 3800002

    Rozzano, Milano, 20089, Italy

  • Investigational Site Number : 3800003

    Pavia, 27100, Italy

  • Investigational Site Number : 3800004

    Palermo, 90127, Italy

  • Investigational Site Number : 3800006

    Reggio Emilia, 42123, Italy

  • Investigational Site Number : 3920001

    Tokyo, 140-8522, Japan

  • Investigational Site Number : 3920002

    Kamogawa, Chiba, 296-0041, Japan

  • Investigational Site Number : 3920003

    Tokyo, 162-8655, Japan

  • Investigational Site Number : 3920004

    Himeji, Hyōgo, 670-0849, Japan

  • Investigational Site Number : 3920005

    Kiyose, Tokyo, 204-8522, Japan

  • Investigational Site Number : 5280001

    Rotterdam, 3015 CE, Netherlands

  • Investigational Site Number : 5280002

    Alkmaar, 1815 JD, Netherlands

  • Investigational Site Number : 5280003

    The Hague, 2545 CH, Netherlands

  • Investigational Site Number : 5280004

    Breda, 4818 CK, Netherlands

  • Investigational Site Number : 5280005

    Amsterdam, 1105 AZ, Netherlands

  • Investigational Site Number : 6160001

    Bialystok, Podlaskie Voivodeship, 15-044, Poland

  • Investigational Site Number : 6160002

    Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400, Poland

  • Investigational Site Number : 6160003

    Lodz, 90-302, Poland

  • Investigational Site Number : 6160005

    Lodz, Lódzkie, 90-153, Poland

  • Investigational Site Number : 6160006

    Wejherowo, 84-200, Poland

  • Investigational Site Number : 7240001

    L'Hospitalet de Llobregat, Barcelona [Barcelona], 08907, Spain

  • Investigational Site Number : 7240002

    Madrid, Madrid, Comunidad de, 28007, Spain

  • Investigational Site Number : 7240003

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Investigational Site Number : 7240006

    Barcelona, Barcelona [Barcelona], 08036, Spain

  • Investigational Site Number : 7240007

    Barcelona, Barcelona [Barcelona], 08017, Spain

  • Investigational Site Number : 7240012

    Girona, Girona [Gerona], 17005, Spain

  • Investigational Site Number : 7920001

    Istanbul, 34093, Turkey (Türkiye)

  • Investigational Site Number : 7920002

    Akdeniz, 33070, Turkey (Türkiye)

  • Investigational Site Number : 7920003

    Adana, 01330, Turkey (Türkiye)

  • Investigational Site Number : 7920004

    İzmit, 41001, Turkey (Türkiye)

  • Investigational Site Number : 7920005

    Ankara, 06620, Turkey (Türkiye)

  • Investigational Site Number : 7920006

    Samsun, 55139, Turkey (Türkiye)

  • Investigational Site Number : 8260001

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Investigational Site Number : 8260003

    North Shields, North Tyneside, NE29 8NH, United Kingdom

  • Investigational Site Number : 8260004

    Lancaster, LA1 4RP, United Kingdom

  • Investigational Site Number : 8260005

    Reading, RG1 5AN, United Kingdom

  • Investigational Site Number : 8260008

    Norwich, Norfolk, NR4 7UY, United Kingdom

  • Investigational Site Number : 8260009

    Cambridge, Cambridgeshire, CB23 3RE, United Kingdom

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

    Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

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

    Charleston, South Carolina, 29425, United States

  • Metroplex Pulmonary and Sleep Center- Site Number : 8400014

    McKinney, Texas, 75069, United States

  • My Community Research Center- Site Number : 8400023

    Miami, Florida, 33155, United States

  • NYU Langone Medical Center- Site Number : 8400032

    New York, New York, 10016, United States

  • Northwestern Memorial Hospital- Site Number : 8400043

    Chicago, Illinois, 60611, United States

  • Oncoclínicas UMC- Site Number : 0760007

    Uberlândia, Minas Gerais, 38411-186, Brazil

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

    Philadelphia, Pennsylvania, 19104, United States

  • Pioneer Research Solutions, Inc.- Site Number : 8400048

    Sugar Land, Texas, 77479, United States

  • Plano Primary Care Clinic- Site Number : 8400019

    Plano, Texas, 75024, United States

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

    Plantation, Florida, 33324, United States

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

    Phoenix, Arizona, 85006, United States

  • Pulmonary and Medicine Associates- Site Number : 8400057

    Warren, Michigan, 48088, United States

  • Southeastern Research Center- Site Number : 8400008

    Winston-Salem, North Carolina, 27103, United States

  • Southern California Institute for Respiratory Diseases- Site Number : 8400002

    Los Angeles, California, 90048, United States

  • Temple University Hospital- Site Number : 8400015

    Philadelphia, Pennsylvania, 19140, United States

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

    Tyler, Texas, 75708, United States

  • University of Alabama at Birmingham- Site Number : 8400040

    Birmingham, Alabama, 35233, United States

  • University of Connecticut Health Center- Site Number : 8400020

    Farmington, Connecticut, 06032, United States

  • University of Kansas Medical Center- Site Number : 8400045

    Kansas City, Kansas, 66160, United States

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

    Ann Arbor, Michigan, 48109, United States

  • WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760004

    Porto Alegre, Rio Grande do Sul, 91010-006, Brazil

  • Washington University- Site Number : 8400046

    St Louis, Missouri, 63110, United States

  • Yale New Haven Hospital- Site Number : 8400065

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.