NCT05600777

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

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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 975 (estimated)
• Sponsor: Bellus Health Inc. - a GSK company · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 24 weeks.

Conditions

• Cough
• Refractory Chronic Cough

Interventions

Type	Name	Description
DRUG	BLU-5937	Oral administration of BLU-5937 Tablets
DRUG	Placebo	Oral administration of matching placebo for BLU-5937 Tablets

Timeline

• Start date: 2022-12-05
• Primary completion: 2026-06-11
• Completion: 2027-03-17
• First posted: 2022-10-31
• Last updated: 2026-04-15

Locations

252 sites across 13 countries: United States, Australia, Canada, China, Czechia, Germany, India, Japan, New Zealand, Slovakia, South Korea, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study