Bronchiectasis
Conditions
Sponsors
Obara Kentaro
Eligibility
Sex/Gender
All
Inclusion criteria
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 forced expiratory volume in 1 second (FEV1) % predicted >= 30%. - Participants with at least 2 moderate or 1 severe Pulmonary exacerbations (PEs) in the past 12 months.
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: - Have bronchiectasis due to cystic fibrosis, hypogammaglobulinemia, common variable immunodeficiency, known active nontuberculous mycobacteria 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. - Currently on active treatment for allergic bronchopulmonary aspergillosis. - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Annualized rate of moderate or severe Pulmonary exacerbations (PEs) over the treatment period [Time Frame: Baseline up to End of Treatment (EOT) (24-52 weeks)] Annualized rate of moderate or severe PEs over the placebo-controlled treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to first moderate or severe PE over the treatment period [Time Frame: Baseline up to EOT (24-52 weeks)] 2. Percentage of participants who are PE free over the treatment period [Time Frame: Baseline up to EOT (24-52 weeks)] 3. Annualized rate of severe PEs over the treatment period [Time Frame: Baseline up to EOT (24-52 weeks)] 4. Percentage of participants who are severe PE free over the treatment period [Time Frame: Baseline up to EOT (24-52 weeks)] 5. Time to first severe PE over the treatment period [Time Frame: Baseline up to EOT (24-52 weeks)] 6. Change From Baseline in FEV1 at Week 8 and Week 24 [Time Frame: Week 8 and Week 24] FEV1 is force expiratory volume in 1 second. 7. Number of days of new and/or added (in participants with maintenance antibiotic use) antibiotic use [Time Frame: Baseline up to EOT (24-52 weeks)] 8. Change from Baseline in Quality-Of-Life-Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score in Adult Participants at Week 24 [Time Frame: Week 24] The QOL-B is a validated, self-administered patient reported outcome (PRO) that assesses symptoms, functioning and health-related QOL for subjects with NCFB. 9. Change from baseline in the St. George's Respiratory Questionnaire (SGRQ) total score at Week 24 [Time Frame: Week 24] SGRQ is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. A global score ranges from 0 to 100. Scores by dimension are calculated for 3 domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A lower score indicates better quality of life. 10. Percentage of participants with a decrease from baseline of at least 4 points in SGRQ total score at Week 24 [Time Frame: Week 24] Refer to the secondary outcome-9 for "SGRQ". 11. Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), serious adverse events (SAEs), and adverse events (AEs) leading to permanent study treatment | — |
Countries
Argentina, Brazil, Canada, Chile, China, Czechia, Denmark, France, Germany, Greece, Israel, Italy, Japan, Netherlands, Poland, Spain, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactUnit Clinical
Sanofi K.K.
Outcome results
None listed