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

JRCT ID: jRCT2031230611

Registered date:01/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: refractory chronic cough
• Date of first enrollment: 13/02/2024
• Target sample size: 825
• Countries of recruitment: United States,Japan,Australia,Japan,Czechia,Japan,Germany,Japan,India,Japan,Korea, Republic of,Japan,New Zealand,Japan,Slovakia,Japan,Taiwan,Japan,United Kingdom,Japan
• Study type: Interventional

Intervention(s)

Biological:BLU-5937
BLU-5937 oral dose 25 mg or 50 mg twice a day.

Biological:Placebo
Matching Placebo for BLU-5937 oral dose twice a day.

Outcome(s)

• Primary Outcome: 24-hour cough frequency at Week 24

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kawamoto Mika
• Secondary ID(s): NCT05600777