A Study to Access Activity and Safety with SAR445399 Compared with Placebo in Participants Aged 18 to 80 Years of Age with Non-Cystic Fibrosis Bronchiectasis
Key facts
- Where
- Bendorf, Berlin, Essen és Frankfurt am Main, NémetországSee the 4 sites
- Phase
- 2. fázis
Where in Németország
- KPPK GmbHBendorf, NémetországToborzás még nem indult
- Institut fur Allergie und Asthmaforschung Berlin, IAABBerlin, NémetországToborzás még nem indult
- Universitaetsklinikum Essen (AoR)Essen, NémetországToborzás még nem indult
- IKF Pneumologie GmbH & Co. KGFrankfurt am Main, NémetországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sanofi-Aventis Recherche & Developpement
- Trial code
- EU 2025-523403-29-00
- Record updated
- 2026. október 30.
- Original description
To assess the activity of SAR445399 compared to placebo on mucus plug score (MPS) reduction in participants with non-cystic fibrosis bronchiectasis (NCFB)Read full original descriptionShow less
A Randomized, Double-blinded, Placebo-controlled, Parallel Group, Phase 2a Study to Assess the Activity, Safety, and Tolerability of SAR445399 in Adult Participants with Non-Cystic Fibrosis Bronchiectasis (NCFB).
To assess the activity of SAR445399 compared to placebo on mucus plug score (MPS) reduction in participants with non-cystic fibrosis bronchiectasis (NCFB)
Inclusion: Participants must be 18 to 80 years of age inclusive, at the time of signing the informed consent; Clinical history consistent with NCFB, such as chronic productive cough and/or recurrent respiratory infections; Documented evidence of at least 2 PEx defined as episodes requiring a physician-prescribed course of antibiotics (oral and/or IV) for ≥5 days for signs and symptoms of respiratory infection within the 12 months prior to the Screening Visit; Radiologic evidence of bronchiectasis, confirmed by a chest HRCT; A minimum MPS of 4 (out of maximum 18) on chest HRCT performed before Baseline Visit; Current sputum production with a documented history of chronic expectoration lasting ≥3 months within the previous 12 months; Participants must have a post-bronchodilator FEV1 ≥30% of predicted normal value.
Exclusion: Active NTM pulmonary disease currently requiring or receiving antimycobacterial treatment, or history of NTM pulmonary disease with incomplete treatment. Participants with NTM identified at Screening in association with symptoms or radiological findings warranting therapeutic evaluation according to ATS/IDSA criteria are also excluded; Diagnosis of ABPA or any of the allergic bronchopulmonary mycoses; History of significant hemoptysis (requiring medical intervention and/or requiring blood transfusion); Known or suspected immunosuppression, including history of invasive opportunistic infections (eg., histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), despite infection resolution, or otherwise recurrent infections of abnormal frequency, or prolonged infections suggesting an immune-compromised status, as judged by the Investigator; Participants with active autoimmune disease or participants using immunosuppressive therapy for autoimmune disease, including but not limited to connective tissue diseases (eg., systemic lupus erythematosus, scleroderma, polymyositis, dermatomyositis, mixed connective tissue disease), rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, Hashimoto's thyroiditis, Graves' disease, primary biliary cirrhosis, and psoriasis vulgaris; A primary diagnosis of smoking-related COPD or asthma as determined by the Investigator. Participants with comorbid smoking-related COPD may be included if bronchiectasis is confirmed as their primary diagnosis and is the predominant cause of their respiratory symptoms; Bronchiectasis due to any of the following: CF, CVID, AAT or PCD; Current tobacco smokers.