A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis.

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002533-32-DK

Enrollment

240

Registered

2017-11-09

Start date

2018-08-28

Completion date

Unknown

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0 Level: SOC Classification code 10038738 Term: Respiratory, thoracic and mediastinal disorders System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.0 Level: PT Classification code 10006445 Term: Bronchiectasis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: INS1007 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: not available CAS Number: not availabl Current Sponsor code: INS1007 Other descriptive name: AZD7986 Concentration un

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects who have given their signed, informed consent, are male or female between 18 and 85 years of age (inclusive) with a body mass index > 18.5 at Screening (Visit 1) and have a clinical history consistent with NCFBE will be eligible for enrollment in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 96 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 144

Exclusion criteria

Exclusion criteria: Subjects who have a primary diagnosis of chronic obstructive pulmonary disease or asthma, have bronchiectasis due to cystic fibrosis, hypogammaglobulinemia, common variable immunodeficiency, or a1-antitrypsin deficiency, are current smokers as defined per Centers for Disease Control and Prevention criteria, or currently being treated for a nontuberculous mycobacterial lung infection, allergic bronchopulmonary aspergillosis, tuberculosis or have a clinical diagnosis of Papillon-Lefèvre Syndrome will not be eligible for enrollment in the study.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of INS1007 compared with placebo on time to first pulmonary exacerbation over the 24-week treatment period. To assess the safety and tolerability of INS1007 relative to placebo based on adverse events (AEs), vital signs and electrocardiogram (ECG) measurements, physical exams and clinical laboratory evaluations.;Secondary Objective: 1. To evaluate the effect of INS1007 compared with placebo on quality of life (QOL), as assessed by the Quality of Life Questionnaire-Bronchiectasis (QOL-B), Respiratory Symptoms Domain score, over the 24-week treatment period. 2. To evaluate the effect of INS1007 compared with placebo on lung function, as measured by forced expiratory volume in 1 second (FEV1), over the 24-week treatment period. 3. To evaluate the effect of INS1007 compared with placebo on the concentration of active neutrophil elastase (NE) in sputum, as measured by the difference between the pre-treatment concentration and on-treatment concentration. 4. To evaluate the effect of INS1007 compared with placebo on the rate of pulmonary exacerbations over the 24-week treatment period.;Primary end point(s): The primary endpoint is the time to the first pulmonary exacerbation over the 24-week treatment period. Pulmonary exacerbation definition - A pulmonary exacerbation in this study is defined as having 3 or more of the following symptoms for at least 48 hours resulting in a physician’s decision to prescribe antibiotics. 1. Increased cough; 2. Increased sputum volume or change in sputum consistency; 3. Increased sputum purulence; 4. Increased breathlessness and/or decreased exercise tolerance; 5. Fatigue and/or malaise; 6. Hemoptysis. Subjects on chronic macrolide therapy whose only change in therapy is dose or frequency adjustment will not meet the definition of exacerbation. ;Timepoint(s) of evaluation of this end point: The time to the first pulmonary exacerbation over the 24-week treatment period.	—

Measure

Time frame

Main Objective: To evaluate the effect of INS1007 compared with placebo on time to first pulmonary exacerbation over the 24-week treatment period. To assess the safety and tolerability of INS1007 relative to placebo based on adverse events (AEs), vital signs and electrocardiogram (ECG) measurements, physical exams and clinical laboratory evaluations.;Secondary Objective: 1. To evaluate the effect of INS1007 compared with placebo on quality of life (QOL), as assessed by the Quality of Life Questionnaire-Bronchiectasis (QOL-B), Respiratory Symptoms Domain score, over the 24-week treatment period. 2. To evaluate the effect of INS1007 compared with placebo on lung function, as measured by forced expiratory volume in 1 second (FEV1), over the 24-week treatment period. 3. To evaluate the effect of INS1007 compared with placebo on the concentration of active neutrophil elastase (NE) in sputum, as measured by the difference between the pre-treatment concentration and on-treatment concentration. 4. To evaluate the effect of INS1007 compared with placebo on the rate of pulmonary exacerbations over the 24-week treatment period.;Primary end point(s): The primary endpoint is the time to the first pulmonary exacerbation over the 24-week treatment period. Pulmonary exacerbation definition - A pulmonary exacerbation in this study is defined as having 3 or more of the following symptoms for at least 48 hours resulting in a physician’s decision to prescribe antibiotics. 1. Increased cough; 2. Increased sputum volume or change in sputum consistency; 3. Increased sputum purulence; 4. Increased breathlessness and/or decreased exercise tolerance; 5. Fatigue and/or malaise; 6. Hemoptysis. Subjects on chronic macrolide therapy whose only change in therapy is dose or frequency adjustment will not meet the definition of exacerbation. ;Timepoint(s) of evaluation of this end point: The time to the first pulmonary exacerbation over the 24-week treatment period.

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Secondary

Measure	Time frame
Secondary end point(s): 1. Change from Baseline in QOL-B Respiratory Symptoms Domain score over the 24-week treatment period. 2. Change from Screening in post-bronchodilator FEV1 over the 24-week treatment period. 3. Change in concentration of active NE in sputum from pre-treatment (defined as the average of Screening and Day 1 concentrations) to on-treatment (defined as the average of Week 12 and Week 24 concentrations). 4. Rate of pulmonary exacerbations (number of events per person-time) over the 24-week treatment period. ;Timepoint(s) of evaluation of this end point: Over the 24-week treatment period.	—

Measure

Time frame

Secondary end point(s): 1. Change from Baseline in QOL-B Respiratory Symptoms Domain score over the 24-week treatment period. 2. Change from Screening in post-bronchodilator FEV1 over the 24-week treatment period. 3. Change in concentration of active NE in sputum from pre-treatment (defined as the average of Screening and Day 1 concentrations) to on-treatment (defined as the average of Week 12 and Week 24 concentrations). 4. Rate of pulmonary exacerbations (number of events per person-time) over the 24-week treatment period. ;Timepoint(s) of evaluation of this end point: Over the 24-week treatment period.

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Countries

Australia, Belgium, Bulgaria, Denmark, Germany, Italy, Korea, Republic of, Netherlands, New Zealand, Poland, Singapore, Spain, Sweden, United Kingdom, United States

Contacts

Public ContactClinical trial contact

Insmed Incorporated

kevin.schutz@insmed.com19089474393

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026