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

NCT05600777
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
997
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Lead sponsor
Bellus Health Inc. - a GSK company
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Start date
2022-12-05
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Number of sites
242
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Summary
This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).
clinicaltrials.gov
Acronym
CALM-2
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Short title
A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough
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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)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2027-03-17
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First posted
2022-10-31
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Registry last updated
2026-07-14
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Primary completion date
2026-06-10
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Start date
2022-12-05
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Actual participants
997
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Participants
997
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
242
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Bellus Health Inc. - a GSK company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05600777
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ClinicalTrials.gov ID
NCT05600777
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. 24-Hour Cough Frequency

    Timeframe: Week 24

    Assessed using an ambulatory cough monitor

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

    Timeframe: Up to Week 24

    An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death, is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of a study participant; or other situations as per the medical or scientific judgment of the Investigator.

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

    Timeframe: Up to Week 24

    An AEMI is an event of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring is appropriate. The following are AEMIs for this study: taste disturbance, oral hypoesthesia, oral paresthesia, and new or worsening findings of the cornea.

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

    Timeframe: Up to Week 24

    An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death, is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of a study participant; or other situations as per the medical or scientific judgment of the Investigator.

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

    Timeframe: Up to Week 24

    An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death, is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of a study participant; or other situations as per the medical or scientific judgment of the Investigator.

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

    Timeframe: Baseline, Week 24

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

    Timeframe: Baseline, Week 24

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

    Timeframe: Baseline, Week 24

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

    Timeframe: Baseline, Week 24

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

    Timeframe: Baseline, Week 24

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

    Timeframe: Baseline, Week 24

  12. 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

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

    Timeframe: Baseline, Week 24

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

    Timeframe: Baseline, Week 24

  15. 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

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

    Timeframe: Baseline, Week 24

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

    Timeframe: Baseline, Week 24

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

    Timeframe: Baseline, Week 24

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

    Timeframe: Baseline, Week 24

  20. 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

  21. 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

  22. 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

  23. 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

  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

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

    Timeframe: Baseline, Week 24

And 4 more, listed on the interactive page.

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

    Timeframe: Baseline, Week 24

    Assessed by Cough Severity Visual Analogue Scale \[VAS\] by the participant on a 100 mm visual analogue scale where higher scores indicate greater severity.

  2. 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

    Assessed by Cough Severity Visual Analogue Scale \[VAS\] by the participant on a 100 mm visual analogue scale where higher scores indicate greater severity.

  3. Awake Cough Frequency at Week 24

    Timeframe: Week 24

    Assessed using an ambulatory cough monitor

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

    Timeframe: Baseline, Week 24

    Assessed using an ambulatory cough monitor

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

    Timeframe: Baseline, Week 24

    The LCQ is a patient-reported quality of life (QOL) measure of chronic cough. The questionnaire consists of 19 items to which the patient responds on a 7-point Likert response scale (from 1 to 7). Each item assesses symptoms during cough and the impact of cough on 3 domains: physical, psychological, and social. Domain scores range from 1-7, and the total score ranges from 3 - 21; a higher score indicates a better quality of life.

  6. 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

    The LCQ is a patient-reported quality of life (QOL) measure of chronic cough. The questionnaire consists of 19 items to which the patient responds on a 7-point Likert response scale (from 1 to 7). Each item assesses symptoms during cough and the impact of cough on 3 domains: physical, psychological, and social. Domain scores range from 1-7, and the total score ranges from 3 - 21; a higher score indicates a better quality of life.

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

    Timeframe: Baseline, Week 24

    The CCD is a participant-completed daily diary used to assess chronic cough. The CCD score ranges from 0 to 16, with a higher score indicating worse symptoms.

  8. Percentage of Participants with CCD Response at Week 24

    Timeframe: Week 24

    Percentage of participants with CCD response will be summarized.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No

  • 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

  • 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
Sources for eligibility
clinicaltrials.gov

  • GSK Investigational SiteFoley, United States
  • GSK Investigational SiteLitchfield Park, United States
  • GSK Investigational SitePhoenix, United States
  • GSK Investigational SiteLos Angeles, United States
  • GSK Investigational SiteLos Angeles, United States
  • GSK Investigational SiteParamount, United States
  • GSK Investigational SiteSacramento, United States
  • GSK Investigational SiteSan Diego, United States
  • GSK Investigational SiteSan Diego, United States
  • GSK Investigational SiteSan Jose, United States
  • GSK Investigational SiteAurora, United States
  • GSK Investigational SiteColorado Springs, United States
  • GSK Investigational SiteDenver, United States
  • GSK Investigational SiteWheat Ridge, United States
  • GSK Investigational SiteWashington D.C., United States
  • GSK Investigational SiteDaytona Beach, United States
  • GSK Investigational SiteFort Lauderdale, United States
  • GSK Investigational SiteJacksonville, United States
  • GSK Investigational SiteLeesburg, United States
  • GSK Investigational SiteOrlando, United States
  • GSK Investigational SiteSanta Rosa Beach, United States
  • GSK Investigational SiteSarasota, United States
  • GSK Investigational SiteSweetwater, United States
  • GSK Investigational SiteCumming, United States
  • GSK Investigational SiteChicago, United States

And 217 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2024-513462-19-00
  • BUS-P3-02
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)