Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis

• Register: ClinicalTrials.gov
• Last refreshed on: 3 April 2023
• Main ID: NCT03218917
• Date of registration: 11/07/2017
• Prospective Registration: Yes
• Primary sponsor: Insmed Incorporated
• Public title: Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis
• Scientific title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety & Tolerability, and PK of INS1007 Administered Once Daily for 24 Weeks in Subjects With Non-CF Bronchiectasis - The Willow Study
• Date of first enrolment: October 31, 2017
• Target sample size: 256
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03218917
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

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

Contacts

• Name: Carlos Fernandez, MD
• Affiliation: Insmed Incorporated

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Clinical history consistent with NCFBE (cough, chronic sputum production and/or
recurrent respiratory infections)

2. Are current sputum producers with a history of chronic expectoration and able to
provide a sputum sample during Screening

3. Have at least 2 documented pulmonary exacerbations in the past 12 months before
Screening

Exclusion Criteria:

1. Have a primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma

2. Have bronchiectasis due to cystic fibrosis (CF), hypogammaglobulinemia, common
variable immunodeficiency, or alpha1-antitrypsin deficiency

3. Are current smokers

4. Are currently being treated for a nontuberculous mycobacterial lung infection,
allergic bronchopulmonary aspergillosis, or tuberculosis

5. Have any acute infections, (including respiratory infections)



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Non-Cystic Fibrosis Bronchiectasis

Intervention(s)

Drug: Brensocatib 25 mg

Drug: Brensocatib 10 mg

Drug: Placebo

Primary Outcome(s)

Time to the First Pulmonary Exacerbation Over 24-Week Treatment Period [Time Frame: Baseline (Day 1) to Week 24]

Secondary Outcome(s)

Change From Baseline in Concentration of Active Neutrophil Elastase (NE) in Sputum [Time Frame: Baseline (Day 1) to Week 24]

Number of Participants Who Experienced a Pulmonary Exacerbation [Time Frame: Baseline (Day 1) to Week 24]

Change From Screening in Post-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Over 24-Week Treatment Period [Time Frame: Screening (Days -42 to -1) to Week 24]

Change From Baseline in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score Over 24 Week Treatment Period [Time Frame: Baseline (Day 1) to Week 24]

Secondary ID(s)

2017-002533-32

INS1007-201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 08/02/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03218917