BLU-5937 50 mg for Chronic Refractory Cough

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Chronic Refractory CoughBLU-5937 - Drug
Eligibility
18 - 80
All Sexes
What conditions do you have?
Select

Study Summary

This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).

Eligible Conditions
  • Chronic Refractory Cough

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Week 12

Baseline, Week 12
Change from Baseline in Cough Severity Visual Analogue Scale at Week 12
Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12
Percentage of Participants With a ≥1.3-point Increase From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 12
Percentage of Participants With ≥ 30mm Reduction, ≥ 20mm Reduction From Baseline in Cough Severity Visual Analog Scale (VAS) at Week 12
Percentage of Participants With ≥30%, ≥50%, and ≥70% Reduction From Baseline in 24-Hour Cough Frequency at Week 12
Week 12
Coughing

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

BLU-5937 50 mg
1 of 3
BLU-5937 25 mg
1 of 3
Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

675 Total Participants · 3 Treatment Groups

Primary Treatment: BLU-5937 50 mg · Has Placebo Group · Phase 3

BLU-5937 50 mg
Drug
Experimental Group · 1 Intervention: BLU-5937 · Intervention Types: Drug
BLU-5937 25 mg
Drug
Experimental Group · 1 Intervention: BLU-5937 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BLU-5937
2020
Completed Phase 2
~550

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 12

Who is running the clinical trial?

Bellus Health IncLead Sponsor
13 Previous Clinical Trials
4,217 Total Patients Enrolled

Eligibility Criteria

Age 18 - 80 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a woman of child-bearing potential who is using a highly effective method of contraception for at least 14 days.

Who else is applying?

What state do they live in?
Texas100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
How many prior treatments have patients received?
050.0%
3+50.0%