A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough (CALM-1)

• ClinicalTrials.gov Identifier: NCT05599191
• Recruitment Status: Recruiting
• First Posted: October 31, 2022
• Last Update Posted: February 15, 2024
• Sponsor: Bellus Health Inc. - a GSK company
• Information provided by (Responsible Party): Bellus Health Inc. - a GSK company

Tracking Information

• First Submitted Date: October 18, 2022
• First Posted Date: October 31, 2022
• Last Update Posted Date: February 15, 2024
• Actual Study Start Date: October 25, 2022
• Estimated Primary Completion Date: September 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 25, 2022)

24-Hour Cough Frequency [ Time Frame: Week 12 ]

Assessed using an ambulatory cough monitor

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 25, 2022)

• Change from Baseline in Cough Severity Visual Analogue Scale at Week 12 [ Time Frame: Baseline, Week 12 ]
  Assessed by Cough Severity Visual Analogue Scale [VAS] by the participant on a 100 mm visual analog scale where higher scores indicate greater severity.
• Percentage of Participants With ≥ 30mm Reduction, ≥ 20mm Reduction From Baseline in Cough Severity Visual Analog Scale (VAS) at Week 12 [ Time Frame: Baseline, Week 12 ]
  Assessed by Cough Severity Visual Analogue Scale [VAS] by the participant on a 100 mm visual analog scale where higher scores indicate greater severity.
• Percentage of Participants With ≥30%, ≥50%, and ≥70% Reduction From Baseline in 24-Hour Cough Frequency at Week 12 [ Time Frame: Baseline, Week 12 ]
  Assessed using an ambulatory cough monitor
• Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12 [ Time Frame: Baseline, Week 12 ]
  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.
• Percentage of Participants With a ≥1.3-point Increase From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 12 [ Time Frame: Baseline, Week 12 ]
  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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough
• Official Title: A Phase 3, 52-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
• Brief Summary: This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).
• 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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Refractory Chronic Cough

Intervention

• Drug: BLU-5937
  Oral administration of BLU-5937 Tablets
• Drug: Placebo
  Oral administration of matching placebo for BLU-5937 Tablets

Study Arms

• Experimental: BLU-5937 25 mg
  BLU-5937 oral dose 25 mg twice a day.
  Intervention: Drug: BLU-5937
• Experimental: BLU-5937 50 mg
  BLU-5937 oral dose 50 mg twice a day.
  Intervention: Drug: BLU-5937
• Placebo Comparator: Placebo
  Matching Placebo for BLU-5937 oral dose twice a day.
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 20, 2023): 825
• Original Estimated Enrollment (submitted: October 25, 2022): 675
• Estimated Study Completion Date: March 2026
• Estimated Primary Completion Date: September 2025 (Final data collection date for primary outcome measure)

Eligibility 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 (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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: US GSK Clinical Trials call Center; 877-379-3718; GSKClinicalSupportHD@gsk.com

Contact: EU GSK Clinical Trials Call Center; +44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

• Listed Location Countries: Argentina, Belgium, Canada, Colombia, France, Hungary, India, Israel, Netherlands, Poland, South Africa, Spain, Turkey, United Kingdom, United States

Administrative Information

• NCT Number: NCT05599191
• Other Study ID Numbers: 221850; BUS-P3-01 ( Other Identifier: Bellus Health Inc )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Bellus Health Inc. - a GSK company
• Original Responsible Party: Same as current
• Current Study Sponsor: Bellus Health Inc. - a GSK company
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Bellus Health Inc. - a GSK company
• Verification Date: February 2024