NCT05599191

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

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 (CALM-1)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 825 (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 12 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: 2022-10-25
• Primary completion: 2025-12-18
• Completion: 2026-05-28
• First posted: 2022-10-31
• Last updated: 2025-06-10

Locations

191 sites across 14 countries: United States, Argentina, Belgium, Canada, Colombia, France, Hungary, India, Israel, Netherlands, Poland, South Africa, Spain, United Kingdom

Regulatory

• FDA-regulated drug study