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

NCT07547436 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: PDY193722025-523403-29U1111-1322-6304
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a randomized, double-blind, placebo-controlled study to measure the reduction in mucus plug score at 24 weeks of treatment with SAR445399 compared with placebo in adult participants aged 18 to 80 years with non-cystic fibrosis bronchiectasis (NCFB).

Conditions

Non-cystic Fibrosis Bronchiectasis

Keywords

Non-Cystic Fibrosis Bronchiectasis; NCFB; Bronchiectasis

Outcome Measures

Primary Outcomes (1)

• Change from baseline to Week 24 in mucus plug score (MPS) derived from chest high-resolution computerized tomography (HRCT)

  Mucus plug score is determined by counting the number of bronchopulmonary segments that contain at least one mucus plug, defined as a complete occlusion of the airway The total MPS ranges from 0 to 18 with higher scores indicating worse outcome

  from baseline up to Week 24

Secondary Outcomes (16)

• Change from baseline to Week 24 in post-bronchodilator forced expiratory volume in 1 second (FEV1)

  from baseline up to Week 24

• Change from baseline to Week 52 in post-bronchodilator forced expiratory volume in 1 second (FEV1)

  from baseline up to Week 52

• Change from baseline to Week 24 in pre-bronchodilator forced expiratory volume in 1 second (FEV1)

  from baseline up to Week 24

• Change from baseline to Week 52 in pre-bronchodilator forced expiratory volume in 1 second (FEV1)

  from baseline up to Week 52

• Annualized rate of pulmonary exacerbation (PEx) from baseline up to Week 24

  from baseline up to Week 24

Study Arms (2)

Arm A

EXPERIMENTAL

Participants will receive SAR445399

Biological: SAR445399

Arm B

PLACEBO COMPARATOR

Participants will receive placebo

Biological: Placebo

Interventions

SAR445399 BIOLOGICAL

Pharmaceutical form: solution for injection Route of administration: injection

Arm A

Placebo BIOLOGICAL

Pharmaceutical form: solution for injection Route of administration: injection

Arm B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Diagnosis of ABPA or any of the allergic bronchopulmonary mycoses
• Active NTM lung infection or incomplete NTM treatment course
• Bronchiectasis due to any of the following: CF, CVID, AAT or PCD
• History of significant hemoptysis (requiring medical intervention and/or requiring blood transfusion)
• Current tobacco smokers
• 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
• The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: \[Specify Complex Masking\]
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 23, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): October 29, 2027
• Study Completion (Estimated): July 21, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share