A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough

Purpose

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

Conditions

  • Cough
  • Refractory Chronic Cough

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BLU-5937 25 mg 		BLU-5937 oral dose 25 mg twice a day.
  • Drug: BLU-5937
    Oral administration of BLU-5937 Tablets
    Other names:
    • Camlipixant
Experimental
BLU-5937 50 mg 		BLU-5937 oral dose 50 mg twice a day.
  • Drug: BLU-5937
    Oral administration of BLU-5937 Tablets
    Other names:
    • Camlipixant
Placebo Comparator
Placebo 		Matching Placebo for BLU-5937 oral dose twice a day.
  • Drug: Placebo
    Oral administration of matching placebo for BLU-5937 Tablets

More Details

Status
Active, not recruiting
Sponsor
Bellus Health Inc. - a GSK company

Study Contact

Detailed 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.