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BronchiectasisPhase 2NCT06280391

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

A Phase 2 study testing Itepekimab (SAR440340) in people with Bronchiectasis, run by Sanofi at 117 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Bronchiectasis
What is being tested?
Itepekimab (SAR440340)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
314 participants
Where
117 sitesin 20 countries
Study dates
20 Feb 2024to 2 Feb 2026
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Participants were excluded from the study if any of the following criteria apply:
  • Had 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 had not resolved clinically during screening period
  • Had significant haemoptysis
  • Had any clinically significant abnormal laboratory values at Screening or diseases or disorders
Show all 18Show fewer
  • History of lung transplantation
  • History of malignancy within 5 years before Screening, or during the screening period
  • Was being treated with antimicrobial therapy for tuberculosis (TB)
  • Was 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 planned 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 was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

117 sites in 20 countries.

117 sites in 20 countries

United States23 sites

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

    Ann Arbor, Michigan, 48109

  • Allianz Research Institute CO- Site Number : 8400038

    Aurora, Colorado, 80014

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

    Charleston, South Carolina, 29425

  • Northwestern Memorial Hospital- Site Number : 8400043

    Chicago, Illinois, 60611

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

    DuBois, Pennsylvania, 15801

  • University of Connecticut Health Center- Site Number : 8400020

    Farmington, Connecticut, 06032

  • University of Kansas Medical Center- Site Number : 8400045

    Kansas City, Kansas, 66160

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

    Los Angeles, California, 90048

  • Advanced Pulmonary Research Institute- Site Number : 8400007

    Loxahatchee Groves, Florida, 33470

  • Metroplex Pulmonary and Sleep Center- Site Number : 8400014

    McKinney, Texas, 75069

  • High Quality Research- Site Number : 8400047

    Miami, Florida, 33184

  • Yale New Haven Hospital- Site Number : 8400065

    New Haven, Connecticut, 06510

  • NYU Langone Medical Center- Site Number : 8400032

    New York, New York, 10016

  • Avanza Medical Research Center- Site Number : 8400018

    Pensacola, Florida, 32503

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

    Philadelphia, Pennsylvania, 19104

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

    Phoenix, Arizona, 85006

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

    Plantation, Florida, 33324

  • Washington University- Site Number : 8400046

    St Louis, Missouri, 63110

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

    Sugar Land, Texas, 77479

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

    Tyler, Texas, 75708

  • Pulmonary and Medicine Associates- Site Number : 8400057

    Warren, Michigan, 48088

  • Allianz Research Institute- Site Number : 8400013

    Westminster, California, 92683

  • Southeastern Research Center- Site Number : 8400008

    Winston-Salem, North Carolina, 27103

Other trials in United States

Israel9 sites

  • Investigational Site Number : 3760008

    Ashkelon, 7830604

  • Investigational Site Number : 3760006

    Haifa, 3436212

  • Investigational Site Number : 3760003

    Jerusalem, 9103102

  • Investigational Site Number : 3760001

    Jerusalem, 9112001

  • Investigational Site Number : 3760002

    Petah Tikva, 4941492

  • Investigational Site Number : 3760009

    Ramat Gan, 5262100

  • Investigational Site Number : 3760004

    Rehovot, 7610001

  • Investigational Site Number : 3760007

    Tel Aviv, 6423906

  • Investigational Site Number : 3760010

    Tel Aviv, 6789140

Other trials in Israel

Argentina6 sites

  • Investigational Site Number : 0320003

    Buenos Aires, 1121

  • Investigational Site Number : 0320008

    Buenos Aires, 1280

  • Investigational Site Number : 0320001

    Buenos Aires, 1414

  • Investigational Site Number : 0320007

    Córdoba, 5003

  • Investigational Site Number : 0320006

    Mendoza, 5500

  • Investigational Site Number : 0320005

    San Miguel de Tucumán, 4000

Other trials in Argentina

China6 sites

  • Investigational Site Number : 1560005

    Beijing, 100020

  • Investigational Site Number : 1560008

    Changchun, 130021

  • Investigational Site Number : 1560004

    Chengdu, 610041

  • Investigational Site Number : 1560001

    Guangzhou, 510120

  • Investigational Site Number : 1560007

    Shenyang, 110004

  • Investigational Site Number : 1560003

    Xuzhou, 221006

Other trials in China

France6 sites

  • Investigational Site Number : 2500005

    Brest, 29200

  • Investigational Site Number : 2500001

    Lyon, 69004

  • Investigational Site Number : 2500002

    Montpellier, 34090

  • Investigational Site Number : 2500004

    Nice, 06001

  • Investigational Site Number : 2500003

    Paris, 75679

  • Investigational Site Number : 2500006

    Saint-Herblain, 44800

Other trials in France

Germany6 sites

  • Investigational Site Number : 2760005

    Bendorf, 56170

  • Investigational Site Number : 2760010

    Berlin, 12159

  • Investigational Site Number : 2760007

    Essen, 45239

  • Investigational Site Number : 2760003

    Frankfurt, 60596

  • Investigational Site Number : 2760004

    Lübeck, 23552

  • Investigational Site Number : 2760011

    Munich, 80337

Other trials in Germany

Spain6 sites

  • Investigational Site Number : 7240007

    Barcelona, Barcelona [Barcelona], 08017

  • Investigational Site Number : 7240003

    Barcelona, Barcelona [Barcelona], 08035

  • Investigational Site Number : 7240006

    Barcelona, Barcelona [Barcelona], 08036

  • Investigational Site Number : 7240012

    Girona, Girona [Gerona], 17005

  • Investigational Site Number : 7240001

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

  • Investigational Site Number : 7240002

    Madrid, Madrid, Comunidad de, 28007

Other trials in Spain

Turkey (Türkiye)6 sites

  • Investigational Site Number : 7920003

    Adana, 01330

  • Investigational Site Number : 7920002

    Akdeniz, 33070

  • Investigational Site Number : 7920005

    Ankara, 06620

  • Investigational Site Number : 7920001

    Istanbul, 34093

  • Investigational Site Number : 7920004

    İzmit, 41001

  • Investigational Site Number : 7920006

    Samsun, 55139

Other trials in Turkey (Türkiye)

Czechia5 sites

  • Investigational Site Number : 2030006

    Český Krumlov, 381 01

  • Investigational Site Number : 2030002

    Jindřichův Hradec, 377 01

  • Investigational Site Number : 2030004

    Kralupy nad Vltavou, 278 01

  • Investigational Site Number : 2030003

    Pilsen, 305 99

  • Investigational Site Number : 2030005

    Prague, 190 00

Other trials in Czechia

Italy5 sites

  • Investigational Site Number : 3800001

    Milan, Lombardy, 20122

  • Investigational Site Number : 3800004

    Palermo, 90127

  • Investigational Site Number : 3800003

    Pavia, 27100

  • Investigational Site Number : 3800006

    Reggio Emilia, 42123

  • Investigational Site Number : 3800002

    Rozzano, Milano, 20089

Other trials in Italy

Japan5 sites

  • Investigational Site Number : 3920004

    Himeji, Hyōgo, 670-0849

  • Investigational Site Number : 3920002

    Kamogawa, Chiba, 296-0041

  • Investigational Site Number : 3920005

    Kiyose, Tokyo, 204-8522

  • Investigational Site Number : 3920001

    Tokyo, 140-8522

  • Investigational Site Number : 3920003

    Tokyo, 162-8655

Other trials in Japan

Netherlands5 sites

  • Investigational Site Number : 5280002

    Alkmaar, 1815 JD

  • Investigational Site Number : 5280005

    Amsterdam, 1105 AZ

  • Investigational Site Number : 5280004

    Breda, 4818 CK

  • Investigational Site Number : 5280001

    Rotterdam, 3015 CE

  • Investigational Site Number : 5280003

    The Hague, 2545 CH

Other trials in Netherlands

Taiwan5 sites

  • Investigational Site Number : 1580005

    Kaohsiung City, 807

  • Investigational Site Number : 1580002

    New Taipei City, 220

  • Investigational Site Number : 1580006

    Taichung, 404

  • Investigational Site Number : 1580004

    Taipei, 100

  • Investigational Site Number : 1580003

    Taipei, 110

Other trials in Taiwan

United Kingdom5 sites

  • Investigational Site Number : 8260009

    Cambridge, Cambridgeshire, CB23 3RE

  • Investigational Site Number : 8260004

    Lancaster, LA1 4RP

  • Investigational Site Number : 8260001

    Newcastle upon Tyne, NE7 7DN

  • Investigational Site Number : 8260003

    North Shields, North Tyneside, NE29 8NH

  • Investigational Site Number : 8260005

    Reading, RG1 5AN

Other trials in United Kingdom

Chile4 sites

  • Investigational Site Number : 1520004

    Quillota, Valparaiso, 2260877

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 7500587

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 7500692

  • Investigational Site Number : 1520001

    Talca, Maule Region, 3465584

Other trials in Chile

Denmark4 sites

  • Investigational Site Number : 2080002

    Aalborg, 9000

  • Investigational Site Number : 2080005

    Aarhus, 8200

  • Investigational Site Number : 2080004

    Odense, 5000

  • Investigational Site Number : 2080001

    Vejle, 7100

Other trials in Denmark

Brazil3 sites

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

    Porto Alegre, Rio Grande do Sul, 90610-000

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

    Porto Alegre, Rio Grande do Sul, 91010-006

  • Incor - Instituto do Coracao- Site Number : 0760002

    São Paulo, 05403-900

Other trials in Brazil

Canada3 sites

  • Investigational Site Number : 1240003

    Guelph, Ontario, N1H 6J2

  • Investigational Site Number : 1240005

    Sherbrooke, Quebec, J1H 5N4

  • Investigational Site Number : 1240001

    Trois-Rivières, Quebec, G8T 7A1

Other trials in Canada

Poland3 sites

  • Investigational Site Number : 6160001

    Bialystok, Podlaskie Voivodeship, 15-044

  • Investigational Site Number : 6160005

    Lodz, Lódzkie, 90-153

  • Investigational Site Number : 6160002

    Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400

Other trials in Poland

Greece2 sites

  • Investigational Site Number : 3000001

    Ioannina, 455 00

  • Investigational Site Number : 3000003

    Thessaloniki, 570 10

Other trials in Greece

About this study

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

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
Conditions
Bronchiectasis
Being tested
Itepekimab (SAR440340), Placebo
Medical subject headings
Bronchiectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Itepekimab (SAR440340)Drug

    Also called REGN3500

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

  • PlaceboDrug

    • Pharmaceutical form: solution for injection in pre-filled syringe
    • Route of administration: subcutaneous
Study groups in NCT06280391
Study groupRoleWhat they receive
Itepekimab Q2WExperimentalParticipants received itepekimab 300 mg Subcutaneous (SC) injection every 2 weeks (Q2W) for up to 52 weeks
Receives: Drug: Itepekimab (SAR440340)
Itepekimab Q4WExperimentalParticipants received itepekimab 300 mg SC injection Q4W with alternating placebo matched to itepekimab SC administration at the 2-week interval between active study drug for up to 52 weeks
Receives: Drug: Itepekimab (SAR440340); Drug: Placebo
PlaceboPlacebo comparatorParticipants received placebo matched to itepekimab subcutaneous (SC) injection Q2W for up to 52 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Annualized Rate of Adjudicated Moderate or Severe Pulmonary Exacerbations (PEs) Over the Treatment Period

    PEs were recorded by Investigator. Moderate PEs were defined as acute worsening of respiratory symptoms (>=3 symptoms for >=48 hours) requiring antibiotic treatment. Severe PEs were moderate PEs resulting in intravenous antibiotic treatment, hospitalization, observation >24 hours in emergency department/urgent care, or death. Events separated by <14 days were considered as single events. All PE events were adjudicated by an independent committee. For both moderate and severe events to be counted as 2 separate events, they were separated by at least 14 days between any course of antibiotics and/or systemic corticosteroids or 14 days between discharge and new admission in case of hospitalization (severe events only). Annualized rate: number of events divided by total observation duration and was estimated based on negative binomial regression.

    Measured: Baseline (Day 1) up to Week 24 to 52

Secondary outcomes (14)

  1. Time to First Moderate or Severe Pulmonary Exacerbation Over the Treatment Period

    Time to first moderate or severe PE was defined as the onset date of the first moderate or severe PE during the observation period (as per endpoint #1) minus (-) randomization date plus (+) 1. PEs were defined as an acute worsening of respiratory symptoms leading to a prescription in antibiotics (new, addition or change in) and/or systemic corticosteroids and were recorded by Investigator. For both moderate and severe events to be counted as 2 separate events, they must be separated by at least 14 days between any course of antibiotics or 14 days between discharge and new admission in case of hospitalization (severe events only).

    Measured: Baseline (Day 1) up to Week 24 to 52

  2. Percentage of Participants Who Were Pulmonary Exacerbation Free Over the Treatment Period

    PEs were defined as an acute worsening of respiratory symptoms leading to a prescription in antibiotics (new, addition or change in) and/or systemic corticosteroids and were recorded by Investigator. Percentage of participants who were moderate or severe PE free over the treatment period are reported. Moderate and severe PE as defined in endpoint #1. Percentages are rounded off to tenth decimal place.

    Measured: Baseline (Day 1) up to Week 24 to 52

  3. Annualized Rate of Adjudicated Severe Pulmonary Exacerbations Over the Treatment Period

    PEs were recorded by Investigator. Severe PEs were moderate PEs resulting in intravenous antibiotic treatment, hospitalization, observation >24 hours in emergency department/urgent care, or death. All PE events were adjudicated by an independent committee. Annualized rate: number of events divided by total observation duration and was estimated based on negative binomial regression.

    Measured: Baseline (Day 1) up to Week 24 to 52

  4. Percentage of Participants Who Were Severe Pulmonary Exacerbation Free Over the Treatment Period

    PEs were defined as an acute worsening of respiratory symptoms) leading to a prescription in antibiotics (new, addition or change in) and/or systemic corticosteroids and were recorded by Investigator. Severe PE was defined as moderate PE described in endpoint #1 but resulting in intravenous antibiotic treatment, hospitalization, observation for >24 hours in emergency department/urgent care facility or death. Percentage of participants who were severe PE free over the treatment period are reported. Percentages are rounded off to tenth decimal place.

    Measured: Baseline (Day 1) up to Week 24 to 52

  5. Time to First Severe Pulmonary Exacerbation Over the Treatment Period

    Time to first severe PE was defined as the onset date of the first severe PE during the observation period - randomization date + 1. PEs were defined as an acute worsening of respiratory symptoms leading to a prescription in antibiotics (new, addition or change in) and/or systemic corticosteroids and were recorded by Investigator. Severe PE was defined as moderate PE but resulting in intravenous antibiotic treatment, hospitalization, observation for >24 hours in emergency department/urgent care facility or death.

    Measured: Baseline (Day 1) up to Week 24 to 52

  6. Change From Baseline in Pre-bronchodilator (BD) Forced Expiratory Volume in One Second (FEV1) at Weeks 8 and 24

    The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Pre-BD spirometry was performed after a washout period of BD according to their action duration following the European Respiratory Society/American Thoracic Society 2019 guidance. Baseline was defined as the last available value before the first dose of double-blind study drug. Model-based average change from baseline to Weeks 8 and 24 is presented.

    Measured: Baseline (Day 1) and Weeks 8 and 24

  7. Change From Baseline in Post-bronchodilator Forced Expiratory Volume in One Second at Weeks 8 and 24

    The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Post-BD spirometry was performed after 4 actuations of short-acting beta-agonist (albuterol, salbutamol) with post-BD reversibility performed at least 15 minutes following the last actuation. Baseline was defined as the last available value before the first dose of double-blind study drug. Model-based average change from baseline to Weeks 8 and 24 is presented.

    Measured: Baseline (Day 1) and Weeks 8 and 24

  8. Median Days of New and/or Added (in Participants With Maintenance Antibiotic Use) Acute Antibiotics Used to Treat Pulmonary Exacerbation

    PEs were defined as an acute worsening of respiratory symptoms leading to a prescription in antibiotics (new, addition or change in) and/or systemic corticosteroids and were recorded by Investigator. Systemic antibiotics used less than 60 days to treat a NCFB exacerbation were considered. Median number of days of new and/or added acute antibiotics used to treat PE in participants with maintenance antibiotic use is reported.

    Measured: Baseline (Day 1) up to Week 24 to 52

  9. Change From Baseline in Quality-of-Life Questionnaire Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score in Adult Participants at Week 24

    QOL-B is self-administered patient reported outcome (PRO) that assesses symptoms, functioning and health-related QOL for participants with NCFB; contains 37 items in 8 domains (respiratory symptoms, physical functioning, role functioning, emotional functioning, social functioning, vitality, health perceptions and treatment burden). Respiratory Symptoms domain assesses respiratory symptom-related QOL;includes 9 questions (from 29 to 37 of QOL-B Questionnaire). Each of 37 items is scored from 1 to 4, and each of the 8 domains scale scores is standardized on a 0-100 point scale, with higher scores representing fewer symptoms or better functioning/ better QOL.Positive change from baseline=improvement in symptoms. Baseline:last available value before first dose of double-blind study drug. Model-based average change from baseline to Week 24 is presented.

    Measured: Baseline (Day 1) and Week 24

  10. Change From Baseline in Saint Georges Respiratory Questionnaire (SGRQ) Total Score at Week 24

    SGRQ is a 50-item PRO instrument to measure health status of participants with airflow obstruction diseases. Questionnaire is divided into 2 parts: part 1 consists of 8 items pertaining to severity of respiratory symptoms in preceding 4 weeks; part 2 consists of 42 items related to daily activity and psychosocial impacts of individual's respiratory condition. Scores by dimension are calculated for 3 domains: symptoms, activity and impacts (psychosocial). Total score is calculated by summing all positive responses in questionnaire and expressing result as percentage of total weight for questionnaire; ranges 0 (best possible health status) to 100 (worst possible health status); lower score indicates better QOL. Baseline was defined as the last available value before first dose of double-blind study drug. Model-based average change from baseline to Week 24 is presented.

    Measured: Baseline (Day 1) and Week 24

  11. Percentage of Participants With a Decrease From Baseline of at Least 4 Points in Saint Georges Respiratory Questionnaire Total Score at Week 24

    SGRQ is a 50-item PRO instrument to measure health status of participants with airflow obstruction diseases. Questionnaire is divided into 2 parts: part 1 consists of 8 items pertaining to severity of respiratory symptoms in preceding 4 weeks; part 2 consists of 42 items related to daily activity and psychosocial impacts of individual's respiratory condition. Scores by dimension are calculated for 3 domains: symptoms, activity and impacts (psychosocial). Total score is calculated by summing all positive responses in questionnaire and expressing result as percentage of total weight for questionnaire; ranges 0 (best possible health status) to 100 (worst possible health status); lower scores indicate better QOL. Baseline was defined as the last available value before first dose of double-blind study drug. Percentages are rounded off to tenth decimal place.

    Measured: Baseline (Day 1) and Week 24

  12. Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-Emergent AEs of Special Interest (TEAESIs), Treatment-emergent Serious Adverse Events (TESAEs) and TEAEs Leading to Permanent Study Drug Discontinuation

    AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. AESI was any AE (serious or non-serious) of scientific and medical concern specific to Sponsor's product or program, for which ongoing monitoring and immediate notification by Investigator to Sponsor was required. SAE was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were AEs that developed, worsened or became serious during the TE period.

    Measured: From first dose of study drug (Day 1) to a maximum of 72 weeks

  13. Serum Concentrations of Itepekimab

    Blood samples were collected at specified timepoints to obtain serum concentrations of itepekimab.

    Measured: Baseline (Day 1) and Weeks 4, 8, 24, 52, end of treatment (EOT) (Weeks 24-52) and end of study (EOS) (up to Week 72)

  14. Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) Response Against Itepekimab

    Blood samples were collected to evaluate antibodies to itepekimab. Treatment-emergent response was defined as a positive response in the ADA assay post first dose when baseline results were negative or missing. Number of participants with treatment-emergent ADAs against itepekimab is presented.

    Measured: From first dose of study drug (Day 1) to a maximum of 72 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study start20 Feb 2024
  3. Primary completion16 Sep 2025
  4. Study completion2 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
314 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06280391
Sponsor's protocol ID
ACT18018
Other IDs
U1111-1295-3237, 2023-508663-70, 2023
Status last verified
Sep 2026
First submitted
20 Feb 2024
Last updated
7 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Itepekimab (SAR440340) in people with Bronchiectasis, run by Sanofi at 117 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 sites in United States, Israel, Argentina, China, France and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized Rate of Adjudicated Moderate or Severe Pulmonary Exacerbations (PEs) Over the Treatment Period (time frame: Baseline (Day 1) up to Week 24 to 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06280391.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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