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

NCT07650084 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 221851-CHNBUS-P3-02,
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 38

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).

Conditions

Refractory Chronic Cough

Keywords

Cough; Chronic Cough

Outcome Measures

Primary Outcomes (29)

• 24-Hour Cough Frequency

  Assessed using an ambulatory cough monitor

  Week 24

• Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) 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.

  Up to Week 24

• Number of Participants with Adverse Events of Medical Interest (AEMIs) 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.

  Up to Week 24

• Number of Participants with Study Treatment Discontinuation due to AEs and SAEs 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.

  Up to Week 24

• Number of Participants with AEs and SAEs Leading to Study Withdrawal 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.

  Up to Week 24

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

  Baseline, Week 24

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

  Baseline, Week 24

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

  Baseline, Week 24

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

  Baseline, Week 24

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

  Baseline, Week 24

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

  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

  Baseline, Week 24

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

  Baseline, Week 24

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

  Baseline, Week 24

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

  Baseline, Week 24

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

  Baseline, Week 24

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

  Baseline, Week 24

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

  Baseline, Week 24

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

  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

  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

  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

  Baseline, Week 24

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

  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

  Baseline, Week 24

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

  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

  Baseline, Week 24

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

  Baseline, Week 24

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

  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

  Baseline, Week 24

Secondary Outcomes (8)

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

  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

  Baseline, Week 24

• Awake Cough Frequency at Week 24

  Week 24

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

  Baseline, Week 24

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

  Baseline, Week 24

Study Arms (3)

BLU-5937 25 mg

EXPERIMENTAL

BLU-5937 oral dose 25 mg twice a day.

Drug: BLU-5937

BLU-5937 50 mg

EXPERIMENTAL

BLU-5937 oral dose 50 mg twice a day.

Drug: BLU-5937

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

BLU-5937 DRUG

Oral administration of BLU-5937 Tablets.

Also known as: Camlipixant

BLU-5937 25 mg; BLU-5937 50 mg

Placebo DRUG

Oral administration of matching placebo for BLU-5937 Tablets.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (38)

GSK Investigational Site

Leshan, Sichuan, 614003, China

RECRUITING

GSK Investigational Site

Beijing, 100730, China

RECRUITING

GSK Investigational Site

Changsha, 410008, China

RECRUITING

GSK Investigational Site

Chengdu, 610021, China

RECRUITING

GSK Investigational Site

Chengdu, 610041, China

RECRUITING

GSK Investigational Site

Chongqing, 408099, China

RECRUITING

GSK Investigational Site

Dongguan, 523326, China

RECRUITING

GSK Investigational Site

Ganzhou, 341000, China

RECRUITING

GSK Investigational Site

Guangzhou, 510000, China

RECRUITING

GSK Investigational Site

Guangzhou, 510260, China

RECRUITING

GSK Investigational Site

Guilin, 541002, China

RECRUITING

GSK Investigational Site

Hangzhou, 310003, China

RECRUITING

GSK Investigational Site

Hefei, 230001, China

RECRUITING

GSK Investigational Site

Hefei, 230022, China

RECRUITING

GSK Investigational Site

Hohhot, 010017, China

RECRUITING

GSK Investigational Site

Huizhou, 516000, China

RECRUITING

GSK Investigational Site

Huizhou, 516001, China

RECRUITING

GSK Investigational Site

Jiangsu, 221004, China

RECRUITING

GSK Investigational Site

Jinan, 250021, China

RECRUITING

GSK Investigational Site

Kunming, 650032, China

RECRUITING

GSK Investigational Site

Liuzhou, China

RECRUITING

GSK Investigational Site

Meizhou, 514700, China

RECRUITING

GSK Investigational Site

Nanchang, 330038, China

RECRUITING

GSK Investigational Site

Pingxiang, 337055, China

RECRUITING

GSK Investigational Site

Shanghai, 200032, China

RECRUITING

GSK Investigational Site

Shanghai, 200065, China

RECRUITING

GSK Investigational Site

Shanghai, 200080, China

RECRUITING

GSK Investigational Site

Shenyang, 110004, China

RECRUITING

GSK Investigational Site

Shenzhen, 518053, China

RECRUITING

GSK Investigational Site

Taizhou, 317000, China

RECRUITING

GSK Investigational Site

Ürümqi, 830001, China

RECRUITING

GSK Investigational Site

Weifang, China

RECRUITING

GSK Investigational Site

Wuxi, 214023, China

RECRUITING

GSK Investigational Site

Xiamen, 361004, China

RECRUITING

GSK Investigational Site

Yangzhou, 225001, China

RECRUITING

GSK Investigational Site

Yinchuan, China

RECRUITING

GSK Investigational Site

Zhanjiang, 524045, China

RECRUITING

GSK Investigational Site

Zhengzhou, 450052, China

RECRUITING

MeSH Terms

Conditions

Chronic Cough; Cough

Interventions

BLU-5937

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study includes a single-blind placebo run-in followed by a double-blind treatment period with centralized randomization identical investigational product presentation and restricted access to treatment assignments except for emergency unblinding. Additionally a study specific masking plan incorporates a masking strategy by restricting access to potentially treatment unblinding data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 16, 2026
• Study Start: November 21, 2025
• Primary Completion (Estimated): August 27, 2027
• Study Completion (Estimated): June 2, 2028
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

Locations

CN (38)