A Phase 3, 24-Week, Randomized, Efficacy and Safety Study with Openlabel Extension of BLU-5937 in Adult Participants with Refractory or Unexplained Chronic Cough (CALM-2)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bellus Health Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

30 Mar 2023 → ongoing

Decision date (initial)

2024-09-03

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

GlaxoSmithKline Research & Development Ltd.

External identifiers

EU CT number

2024-513462-19-00

EudraCT number

2022-000188-38

ClinicalTrials.gov

NCT05600777

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Pharmacokinetic

To assess the effect of BLU-5937 vs placebo on 24-hour cough frequency in adults with RCC (including unexplained chronic cough) and Baseline 24-hour cough frequency at Week 24. To determine the safety of BLU-5937 vs placebo in adults with RCC (including unexplained chronic cough) up to Week 24.

Secondary objectives 1

1. To evaluate the effects of BLU-5937 on other measures of cough frequency and PROs.

Conditions and MedDRA coding

Refractory Chronic Cough, Including Unexplained Chronic Cough

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, European Medicines Agency, Medicines And Healthcare Products Regulatory Agency

Plan to share IPD

Yes

IPD plan description

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1. Between 18 and 80 years of age inclusive 2. Capable of understanding the written informed consent 3. Diagnosis of Refractory chronic cough (including unexplained chronic cough) for ≥ 1 year prior to Screening 4. Participants must meet the cough frequency criteria 5. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to the contraceptive guidance

Exclusion criteria 1

1. 1. Current smoker or vaper or current use of tobacco smoke, cannabis smoke, or nicotine vapors or Individuals who have given up smoking or vaping within the past 6 months, or those with > 20 pack-year smoking history 2. Diagnosis of chronic obstructive pulmonary disease, bronchiectasis, chronic bronchitis, cystic fibrosis, pulmonary sarcoidosis, idiopathic pulmonary fibrosis, or uncontrolled asthma 3. History of upper and/or lower respiratory tract infection or significant change in pulmonary status within 28 days of Screening 4. Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection at Screening 5. Medical history of malignancy and treatment completed ≤ 5 years prior to Screening 6. History of a diagnosis of drug or alcohol dependency or abuse within the last 3 years 7. Positive serological test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C at Screening 8. Previous participation in an investigational study of BLU-5937

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 24-hour cough frequency at Week 24 by a cough monitor in adult participants • Incidence of AEs and SAEs up to Week 24 • Incidence of AEMIs up to Week 24 • Incidence of study treatment discontinuations due to AEs and SAEs leading to study withdrawal up to Week 24 • Changes from Baseline in vital signs at Week 24, clinical laboratory values at Week 24 • Changes from Baseline in ECG values at Week 24

Secondary endpoints 1

1. CS-VAS • Change from Baseline in CS-VAS at Week 24 • CS-VAS response at Week 24 Objective cough frequency recording • Awake cough frequency at Week 24 • 24-hour cough response from Baseline at Week 24 LCQ • Change from Baseline in the LCQ total score at Week 24 • LCQ response at Week 24

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bellus Health Inc.

Sponsor organisation

Bellus Health Inc.

Address

275 Armand-Frappier Blvd

City

Laval

Postcode

H7V 4A7

Country

Canada

Scientific contact point

Organisation

Bellus Health Inc.

Contact name

EU GSK Clinical Trials Call Center

Public contact point

Organisation

Bellus Health Inc.

Contact name

EU GSK Clinical Trials Call Center

Third parties 8

Locations

4 EU/EEA countries · 42 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 104 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

13 submissions — initial application plus substantial / non-substantial modifications