Bronchiectasis Clinical Trial
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 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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Sanofi | Regeneron Pharmaceuticals |
United States, Canada, Chile, Denmark, Israel, Japan, Spain, Turkey, United Kingdom,
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) |
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