Summary

This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).

Age: 18 Years to 80 Years old

Gender: All

Start Date: 10/25/2022

Primary Completion Date (Estimated): 12/18/2025

Study Completion Date (Estimated): 05/28/2026

Accepts Healthy Volunteers: No

Trial Purpose and Description

The primary efficacy objective is to assess the effect of BLU-5937 on 24-hour cough frequency in adults with refractory chronic cough (including unexplained chronic cough) at 12 weeks.

Eligibility Criteria

Age: 18 Years to 80 Years old

Gender: All

Accepts Healthy Volunteers: No

Inclusion criteria:

* Capable of giving signed informed consent

* Refractory chronic cough (including unexplained chronic cough) for at least one year

* Women of child-bearing potential must use a highly effective contraception method during the study and for at least 14 days after the last dose

Exclusion criteria:

* Current smoker/vaper (all forms of smoking and inhaled substances, including, cannabis/tobacco smoke and nicotine vapors) or individuals who have given up smoking within the past 6 months, or those with \>20 pack-year smoking history

* Diagnosis of chronic obstructive pulmonary disease, bronchiectasis, chronic bronchitis, cystic fibrosis, pulmonary sarcoidosis, idiopathic pulmonary fibrosis, uncontrolled asthma, or other significant or progressive airway/respiratory disorder that might affect cough based on clinician assessment

* Respiratory tract infection within 4 weeks before screening

* Laboratory confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection at screening

* History of malignancy in the last 5 years

* History of alcohol or drug abuse within the last 3 years

* Has a positive serologic test for human immunodeficiency virus (HIV), hepatitis B virus surface antigen, or hepatitis C virus.

* Previous participation in a BLU-5937 trial