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) - China Extension
Status: Recruiting
Location: See all (38) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
GSK Investigational Site
RECRUITING
Beijing
GSK Investigational Site
RECRUITING
Changsha
GSK Investigational Site
RECRUITING
Chengdu
GSK Investigational Site
RECRUITING
Chengdu
GSK Investigational Site
RECRUITING
Chongqing
GSK Investigational Site
RECRUITING
Dongguan
GSK Investigational Site
RECRUITING
Ganzhou
GSK Investigational Site
RECRUITING
Guangzhou
GSK Investigational Site
RECRUITING
Guangzhou
GSK Investigational Site
RECRUITING
Guilin
GSK Investigational Site
RECRUITING
Hangzhou
GSK Investigational Site
RECRUITING
Hefei
GSK Investigational Site
RECRUITING
Hefei
GSK Investigational Site
RECRUITING
Hohhot
GSK Investigational Site
RECRUITING
Huizhou
GSK Investigational Site
RECRUITING
Huizhou
GSK Investigational Site
RECRUITING
Jiangsu
GSK Investigational Site
RECRUITING
Jinan
GSK Investigational Site
RECRUITING
Kunming
GSK Investigational Site
RECRUITING
Leshan
GSK Investigational Site
RECRUITING
Liuzhou
GSK Investigational Site
RECRUITING
Meizhou
GSK Investigational Site
RECRUITING
Nanchang
GSK Investigational Site
RECRUITING
Pingxiang
GSK Investigational Site
RECRUITING
Shanghai
GSK Investigational Site
RECRUITING
Shanghai
GSK Investigational Site
RECRUITING
Shanghai
GSK Investigational Site
RECRUITING
Shenyang
GSK Investigational Site
RECRUITING
Shenzhen
GSK Investigational Site
RECRUITING
Taizhou
GSK Investigational Site
RECRUITING
Ürümqi
GSK Investigational Site
RECRUITING
Weifang
GSK Investigational Site
RECRUITING
Wuxi
GSK Investigational Site
RECRUITING
Xiamen
GSK Investigational Site
RECRUITING
Yangzhou
GSK Investigational Site
RECRUITING
Yinchuan
GSK Investigational Site
RECRUITING
Zhanjiang
GSK Investigational Site
RECRUITING
Zhengzhou
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date: 2025-11-21
Estimated Completion Date: 2028-06-02
Participants
Target number of participants: 75
Treatments
Experimental: BLU-5937 25 mg
BLU-5937 oral dose 25 mg twice a day.
Experimental: BLU-5937 50 mg
BLU-5937 oral dose 50 mg twice a day.
Placebo_comparator: Placebo
Matching Placebo for BLU-5937 oral dose twice a day.
Related Therapeutic Areas
Sponsors
Leads: GlaxoSmithKline