Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis

Insmed

Status and phase: Completed; Phase 2

Conditions: Non-Cystic Fibrosis Bronchiectasis

Treatments: Drug: Placebo; Drug: Brensocatib 10 mg; Drug: Brensocatib 25 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03218917

INS1007-201

2017-002533-32 (EudraCT Number)

Details and patient eligibility

About

The purpose of the study is to evaluate if INS1007 can reduce pulmonary exacerbations over a 24-week treatment period in participants with non-cystic fibrosis bronchiectasis.

Full description

Phase 2 randomized, double-blind, placebo-controlled, parallel-group, multicenter, multi-national study to assess the efficacy, safety and tolerability, and pharmacokinetics (PK) of INS1007 administered once daily for 24 weeks in participants with non-cystic fibrosis bronchiectasis (NCFBE).

Enrollment: 256 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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256 participants in 3 patient groups, including a placebo group

Brensocatib 10 mg

Experimental group

Description:

Participants received brensocatib 10 mg once daily (QD) before breakfast, for 24 weeks.

Treatment:

Drug: Brensocatib 10 mg

Brensocatib 25 mg

Experimental group

Description:

Participants received brensocatib 25 mg QD before breakfast, for 24 weeks.

Treatment:

Drug: Brensocatib 25 mg

Placebo

Placebo Comparator group

Description:

Participants received the matching placebo QD before breakfast, for 24 weeks.

Treatment:

Drug: Placebo