A Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Insmed Inc.

Participant type

Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

23 May 2024 → 30 Oct 2025

Decision date (initial)

2024-02-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Insmed Incorporated

External identifiers

EU CT number

2022-502481-24-00

ClinicalTrials.gov

NCT06013241

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacokinetic, Pharmacodynamic

-To evaluate the efficacy of brensocatib at 10 and 40 mg QD compared with placebo in improving nasal symptoms

Secondary objectives 1

1. "- To evaluate the efficacy of brensocatib compared with placebo in improving computed tomography (CT) sinus opacification '- To evaluate the efficacy of brensocatib in comparison to placebo in reducing clinical worsening/acute rhinosinusitis '- To evaluate the efficacy of brensocatib compared with placebo in improving nasal congestion '- To evaluate the efficacy of brensocatib compared with placebo in improving nasal inspiratory flow '-To evaluate the efficacy of brensocatib compared with placebo in improving quality of life '-To evaluate PK of brensocatib in the CRSsNP population '-To evaluate the safety and tolerability of brensocatib compared with placebo over 24 weeks of treatment"

Conditions and MedDRA coding

Chronic Rhinosinusitis without Nasal Polyps (CRSsNP)

Study design 3 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. "Key Inclusion Criteria: • Male or female ≥18 years old and ≤75 years old • At least a 12-week history of CRSsNP • Ongoing symptoms of nasal congestion • Blood eosinophil count of ≤750 cells/μL at Screening • Previous sinonasal surgery for CRS and/or treatment with SCS or antibiotics for CRS within a year of Screening Visit • Received a stable daily dose regimen of MFNS for at least 4 weeks before randomization"

Exclusion criteria 1

1. "Key Exclusion Criteria: • Diagnosis of unilateral or bilateral chronic rhinosinusitis with nasal polyps • Participants who have certain conditions or are receiving certain treatments that could adversely affect the participant’s participation in the study, put the participant at unreasonable risk by participating in the study, or interfere with assessment of the effect of treatment "

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from Baseline to the 28-day average of daily Sinus Total Symptom Score (sTSS)a at Week 24

Secondary endpoints 9

1. Change from Baseline in percentage of sinus (maxillary and ethmoid) opacification as measured by volumetry at Week 24
2. Change from Baseline in modified Lund-MacKay (LMK) CT score at Week 24
3. Participant status indicator for requiring rescue (antibiotics, SCS, and/or nasal surgery) due to worsening of any CRS symptom
4. Change from Baseline to the 28-day average of daily Nasal Congestion Scores (NCS) at Weeks 24
5. Change from Baseline to the 28-day average of daily Peak Nasal Inspiratory Flow (PNIF) at Week 24
6. Change from Baseline in Sino-Nasal Outcome Test (SNOT-22) at Week 24
7. Brensocatib plasma concentration
8. Adverse events (AEs) over 24 weeks of treatment
9. Clinical laboratory test results, vital signs, and electrocardiograms (ECGs) over 24 weeks of treatment

Investigational products

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

Test 2

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Insmed Inc.

Sponsor organisation

Insmed Inc.

Address

700 Us Highway 202/206

City

Bridgewater

Postcode

08807-1704

Country

United States

Scientific contact point

Organisation

Insmed Inc.

Contact name

Yun Irene Gregan

Public contact point

Organisation

Insmed Inc.

Contact name

Yun Irene Gregan

Third parties 12

Locations

11 EU/EEA countries · 51 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 86 files

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

Application history

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