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The trial is taking place at:
A

Asan Medical Center | Clinical Trial Center

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A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough (CALM-2)

B

Bellus Health

Status and phase

Enrolling
Phase 3

Conditions

Refractory Chronic Cough

Treatments

Drug: BLU-5937
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05600777
BUS-P3-02
221851

Details and patient eligibility

About

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

Full 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 24 weeks.

Enrollment

825 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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 (COPD), bronchiectasis, idiopathic pulmonary fibrosis or uncontrolled asthma
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

825 participants in 3 patient groups, including a placebo group

BLU-5937 25 mg
Experimental group
Description:
BLU-5937 oral dose 25 mg twice a day.
Treatment:
Drug: BLU-5937
BLU-5937 50 mg
Experimental group
Description:
BLU-5937 oral dose 50 mg twice a day.
Treatment:
Drug: BLU-5937
Placebo
Placebo Comparator group
Description:
Matching Placebo for BLU-5937 oral dose twice a day.
Treatment:
Drug: Placebo

Trial contacts and locations

100

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Central trial contact

EU GSK Clinical Trials Call Center; US GSK Clinical Trials call Center

Data sourced from clinicaltrials.gov

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