Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06280391
Other study ID # ACT18018
Secondary ID U1111-1295-32372
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 20, 2024
Est. completion date August 11, 2026

Study information

Verified date June 2024
Source Sanofi
Contact Trial Transparency email recommended (Toll free for US & Canada)
Phone 800-633-1610
Email Contact-US@sanofi.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 is 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) will be up to 47-77 weeks. - The treatment duration will be up to 24-52 weeks. - The follow-up duration will be 20 weeks. - Site/phone visits are at a monthly interval.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date August 11, 2026
Est. primary completion date March 24, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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

Country Name City State
Canada Investigational Site Number : 1240003 Guelph Ontario
Chile Investigational Site Number : 1520004 Quillota Valparaíso
Chile Investigational Site Number : 1520003 Santiago Reg Metropolitana De Santiago
Chile Investigational Site Number : 1520001 Talca Maule
Denmark Investigational Site Number : 2080004 Odense C
Israel Investigational Site Number : 3760006 Haifa
Israel Investigational Site Number : 3760001 Jerusalem
Israel Investigational Site Number : 3760003 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
Japan Investigational Site Number : 3920001 Shinagawa-ku Tokyo
Spain Investigational Site Number : 7240003 Barcelona Barcelona [Barcelona]
Spain Investigational Site Number : 7240007 Barcelona Barcelona [Barcelona]
Spain Investigational Site Number : 7240002 Madrid / Madrid Madrid, Comunidad De
Spain Investigational Site Number : 7240010 Valencia
Turkey Investigational Site Number : 7920003 Adana
Turkey Investigational Site Number : 7920005 Ankara
Turkey Investigational Site Number : 7920001 Istanbul
Turkey Investigational Site Number : 7920004 Kocaeli
Turkey Investigational Site Number : 7920002 Mersin
Turkey Investigational Site Number : 7920006 Samsun
United Kingdom Investigational Site Number : 8260004 Lancaster
United Kingdom Investigational Site Number : 8260001 Newcastle upon Tyne
United Kingdom Investigational Site Number : 8260008 Norwich Norfolk
United Kingdom Investigational Site Number : 8260005 Reading
United Kingdom Investigational Site Number : 8260003 Tyne And Wear North Tyneside
United States Allianz Research Institute CO Site Number : 8400038 Aurora Colorado
United States American Health Research Site Number : 8400017 Charlotte North Carolina
United States Clinical Research of Central PA Site Number : 8400005 DuBois Pennsylvania
United States Advanced Pulmonary Research Institute Site Number : 8400007 Loxahatchee Groves Florida
United States Avanza Medical Research Center Site Number : 8400018 Pensacola Florida
United States Clincove: Plano Primary Care Clinic Site Number : 8400019 Plano Texas
United States Broward Pulmonary and Sleep Specialists Site Number : 8400010 Plantation Florida
United States Allianz Research Institute Site Number : 8400013 Westminster California
United States Southeastern Research Center Site Number : 8400008 Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Sanofi Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Chile,  Denmark,  Israel,  Japan,  Spain,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Annualized rate of moderate or severe Pulmonary exacerbations (PEs) over the treatment period Annualized rate of moderate or severe PEs over the placebo-controlled treatment period Baseline up to End of Treatment (EOT) (24-52 weeks)
Secondary Time to first moderate or severe PE over the treatment period Baseline up to End of Treatment (EOT) (24-52 weeks)
Secondary Percentage of participants who are PE free over the treatment period Baseline up to End of Treatment (EOT) (24-52 weeks)
Secondary Annualized rate of severe PEs over the treatment period Baseline up to End of Treatment (EOT) (24-52 weeks)
Secondary Percentage of participants who are severe PE free over the treatment period Baseline up to End of Treatment (EOT) (24-52 weeks)
Secondary Time to first severe PE over the treatment period Baseline up to End of Treatment (EOT) (24-52 weeks)
Secondary Change From Baseline in FEV1 at Week 8 and Week 24 FEV1 is force expiratory volume in 1 second Week 8 and Week 24
Secondary Number of days of new and/or added (in participants with maintenance antibiotic use) antibiotic use Baseline up to End of Treatment (EOT) (24-52 weeks)
Secondary Change from Baseline in QOL-B Respiratory Symptoms Domain Score in Adult Participants at Week 24 The Quality-Of-Life-Bronchiectasis (QOL-B) is a validated, self-administered patient reported outcome (PRO) that assesses symptoms, functioning and health-related QOL for subjects with NCFB. Week 24
Secondary Change from baseline in SGRQ total score at Week 24 The St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. Week 24
Secondary Percentage of participants with a decrease from baseline of at least 4 points in SGRQ total score at Week 24 The St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. Week 24
Secondary Incidence of TEAEs, AESIs, SAEs, and AEs leading to permanent study treatment discontinuation in the treatment-emergent period Baseline up to End of Study (EOS) (44 to 72 weeks)
Secondary Serum concentrations of itepekimab from baseline to end of study Baseline up to End of Study (EOS) (44 to 72 weeks)
Secondary Incidence of treatment-emergent anti-itepekimab antibodies (ADA) responses throughout the study Baseline up to End of Study (EOS) (44 to 72 weeks)
See also
  Status Clinical Trial Phase
Completed NCT05034900 - Does Addition of Oscillatory Positive Expiratory Pressure (OPEP) Device to a Chest Physiotherapy Program Provide Further Health Benefits in Children With Bronchiectasis? N/A
Recruiting NCT04101448 - Prevalence of Bronchiectasis in COPD Patients
Withdrawn NCT03376204 - Pain Mechanisms in Patients With Bronchiectasis
Completed NCT02550821 - Comparison of Physical Activity Level Between Patients With Bronchiectasis and Healthy Subjects
Completed NCT02656992 - Effects of High Intensity Inspiratory Muscle Training on Exercise Capacity in Patients With Bronchiectasis N/A
Completed NCT02282202 - Evaluation of Oscillatory Positive Expiratory Pressure (oPEP) in Bronchiectasis and COPD N/A
Completed NCT01615484 - Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability N/A
Completed NCT02048397 - Pulmonary Rehabilitation Program (PRP) Versus PRP Plus Nutritional Supplementation in Patients With Bronchiectasis N/A
Recruiting NCT01761214 - Bacteriology and Inflammation in Bronchiectasis N/A
Recruiting NCT02527486 - Seoul National University Airway Registry N/A
Completed NCT01578681 - ELTGOL and Bronchiectasis. Respiratory Therapy N/A
Completed NCT01854788 - 3 Airway Clearance Techniques in Non Cystic Fibrosis Bronchiectasis N/A
Completed NCT00769119 - A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Bronchiectasis Phase 2
Completed NCT01117493 - Expert Patient Self-management Programme Versus Usual Care in Bronchiectasis N/A
Terminated NCT00524095 - Bronchiectasis in Chronic Obstructive Pulmonary Disease (COPD) Patients: Role of Prophylaxis Phase 2
Recruiting NCT00129350 - Assessment of Heart and Heart-Lung Transplant Patient Outcomes Following Pulmonary Rehabilitation Phase 1
Completed NCT00656721 - Respiratory Mechanics Effects of Flutter Valve in Bronchiectasis Patients N/A
Completed NCT04081740 - Biological Determinants of Sputum Rheology in Chronic Airway Diseases
Enrolling by invitation NCT02546297 - Comparisons of Inhaled LAMA or LAMA+LABA or ICS+LABA for COPD With Bronchiectasis Phase 4
Completed NCT03628456 - Effect of HFCWO Vests on Spirometry Measurements N/A