Last updated: 10/06/2025 08:50:12

A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic CoughCALM-2

GSK study ID
221851
Clinicaltrials.gov ID
NCT05600777
EudraCT ID
Not applicable
EU CT Number
2024-513462-19-00
Trial status
Recruiting
Recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase 3, 24-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Efficacy and Safety Study with Open-label Extension of BLU-5937 in Adult Participants with Refractory Chronic Cough Including Unexplained Chronic Cough (CALM-2)
Trial description: This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

24-Hour Cough Frequency

Timeframe: Week 24

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 24

Timeframe: Up to Week 24

Number of Participants with Adverse Events of Medical Interest (AEMIs) up to Week 24

Timeframe: Up to Week 24

Number of Participants with Study Treatment Discontinuation due to AEs and SAEs up to Week 24

Timeframe: Up to Week 24

Number of Participants with AEs and SAEs Leading to Study Withdrawal up to Week 24

Timeframe: Up to Week 24

Change from Baseline in Vital Signs: Systolic and Diastolic Blood Pressure (millimeters of mercury [mm Hg]) at Week 24

Timeframe: Baseline, Week 24

Change from Baseline in Vital Sign: Pulse (beats per minute) at Week 24

Timeframe: Baseline, Week 24

Change from Baseline in Vital Sign: Respiratory Rate (breaths per minute) at Week 24

Timeframe: Baseline, Week 24

Change from Baseline in Vital Sign: Body Temperature (degrees Celsius) at Week 24

Timeframe: Baseline, Week 24

Change from Baseline in Vital Sign: Weight (kilograms [kg]) at Week 24

Timeframe: Baseline, Week 24

Change from Baseline in Male Reproductive Hormone: Total Testosterone (nanomoles per liter [nmol/L]) at Week 24

Timeframe: Baseline, Week 24

Change from Baseline in Male Reproductive Hormones: Follicle-Stimulating Hormone [FSH] and Luteinizing Hormone [LH] (international units per liter [IU/L]) at Week 24

Timeframe: Baseline, Week 24

Change from Baseline in Male Reproductive Hormone: Inhibin B (nanograms per liter [ng/L]) at Week 24

Timeframe: Baseline, Week 24

Change from Baseline in Hematology Parameter: Red Blood Cell (RBC) Count (10^12 cells per liter) at Week 24

Timeframe: Baseline, Week 24

Change from Baseline in Hematology Parameters: Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) (grams per liter [g/L]) at Week 24

Timeframe: Baseline, Week 24

Change from Baseline in Hematology Parameter: Hematocrit (percentage) at Week 24

Timeframe: Baseline, Week 24

Change from Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) (femtoliters [fL]) at Week 24

Timeframe: Baseline, Week 24

Change from Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) (picograms per cell [pg/cell]) at Week 24

Timeframe: Baseline, Week 24

Change from Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) (percentage) at Week 24

Timeframe: Baseline, Week 24

Change from Baseline in Hematology Parameters: White Blood Cell (WBC) Count (neutrophils, lymphocytes, monocytes, eosinophils, and basophils) and Platelet Count (10^9 cells per liter) at Week 24

Timeframe: Baseline, Week 24

Change from Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma-Glutamyl Transferase (GGT) (units per liter [U/L]) at Week 24

Timeframe: Baseline, Week 24

Change from Baseline in Clinical Chemistry Parameters: Alkaline Phosphatase (ALP) and Creatine Kinase (CK) (international units per liter [IU/L]) at Week 24

Timeframe: Baseline, Week 24

Change from Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct and Indirect Bilirubin, and Creatinine (micromoles per liter) at Week 24

Timeframe: Baseline, Week 24

Change from Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Calcium, Magnesium, Bicarbonate, Glucose, and Blood Urea Nitrogen (BUN) (millimoles per liter [mmol/L]) at Week 24

Timeframe: Baseline, Week 24

Change from Baseline in Clinical Chemistry Parameters: Protein and Albumin (grams per liter [g/L]) at Week 24

Timeframe: Baseline, Week 24

Change from Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) (milliliters per minute per 1.73 meters squared [mL/min/1.73 m^2]) at Week 24

Timeframe: Baseline, Week 24

Change from Baseline in Clinical Chemistry Parameters: Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) (seconds) at Week 24

Timeframe: Baseline, Week 24

Change from Baseline in Electrocardiogram (ECG) Value: Heart Rate (beats per minute) at Week 24

Timeframe: Baseline, Week 24

Change from Baseline in ECG Value: PR Interval, QT Interval, RR Interval, QRS Interval, and Corrected QT Interval Using Fridericia’s Formula (QTcF) (milliseconds) at Week 24

Timeframe: Baseline, Week 24

Secondary outcomes:

Change from Baseline in Cough Severity Visual Analogue Scale at Week 24

Timeframe: Baseline, Week 24

Percentage of Participants With Greater than or Equal to (>=) 30 mm Reduction From Baseline in Cough Severity Visual Analog Scale at Week 24

Timeframe: Baseline, Week 24

Awake Cough Frequency at Week 24

Timeframe: Week 24

Percentage of Participants With >= 30 percent (%) Reduction From Baseline in 24-Hour Cough Frequency at Week 24

Timeframe: Baseline, Week 24

Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 24

Timeframe: Baseline, Week 24

Percentage of Participants With a >= 1.3-point Increase From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 24

Timeframe: Baseline, Week 24

Change from Baseline in the Chronic Cough Diary (CCD) Score at Week 24

Timeframe: Baseline, Week 24

Percentage of Participants with CCD Response at Week 24

Timeframe: Week 24

Interventions:
  • Drug: BLU-5937
  • Drug: Placebo
    • Enrollment:
    975
    Primary completion date:
    2026-17-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Cough, Refractory Chronic Cough
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    December 2022 to March 2027
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 80 Years
    Accepts healthy volunteers
    No
    • Capable of giving signed informed consent
    • Refractory chronic cough (including unexplained chronic cough) for at least one year
    • 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
    Inclusion and exclusion criteria
    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

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Aurora, CO, United States, 80012
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Changhua, Taiwan, 50006
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Franklin, TN, United States, 37067
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Fukuoka, Japan, 812-8582
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Fukuoka, Japan, 819-8555
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Liuzhou, China
    Status
    Recruiting
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    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Recruiting
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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