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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06013241




Registration number
NCT06013241
Ethics application status
Date submitted
22/08/2023
Date registered
28/08/2023

Titles & IDs
Public title
A Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
Scientific title
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps - The BiRCh Study
Secondary ID [1] 0 0
2022-502481-24-00
Secondary ID [2] 0 0
INS1007-221
Universal Trial Number (UTN)
Trial acronym
BiRCh
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Rhinosinusitis Without Nasal Polyps 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Brensocatib
Treatment: Drugs - Placebo
Treatment: Drugs - Mometasone furoate nasal spray (MFNS)

Experimental: Brensocatib 40 mg - Participants will receive brensocatib 40 mg tablet, orally, QD for 24 weeks along with mometasone furoate nasal spray (MFNS) by nasal route as background therapy at a stable dose according to the Investigator's discretion and local guidance.

Experimental: Brensocatib 10 mg - Participants will receive brensocatib 10 mg tablet, orally, QD for 24 weeks along with MFNS by nasal route as background therapy at a stable dose according to the Investigator's discretion and local guidance.

Placebo comparator: Placebo - Participants will receive a brensocatib-matching placebo tablet, orally, QD for 24 weeks along with MFNS by nasal route as background therapy at a stable dose according to the Investigator's discretion and local guidance.


Treatment: Drugs: Brensocatib
Film-coated tablet.

Treatment: Drugs: Placebo
Film-coated tablet.

Treatment: Drugs: Mometasone furoate nasal spray (MFNS)
Nasal spray suspension.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to the 28-day Average of Daily Sinus Total Symptom Score (sTSS) at Week 24
Timepoint [1] 0 0
Baseline and Week 24
Secondary outcome [1] 0 0
Change From Baseline in Percentage of Sinus (Maxillary and Ethmoid) Opacification as Measured by Volumetry at Week 24
Timepoint [1] 0 0
Baseline and Week 24
Secondary outcome [2] 0 0
Change From Baseline in Modified Lund-MacKay (LMK) Computed Tomography (CT) Score at Week 24
Timepoint [2] 0 0
Baseline and Week 24
Secondary outcome [3] 0 0
Participant Status Indicator Assessed as Percentage of Participants Requiring Rescue (Antibiotics, Systemic Corticosteroids [SCS], and/or Nasal Surgery) due to Worsening of any Chronic Rhinosinusitis (CRS) Symptoms
Timepoint [3] 0 0
Baseline to Week 24
Secondary outcome [4] 0 0
Change From Baseline to the 28-day Average of Daily Nasal Congestion Score (NCS) at Week 24
Timepoint [4] 0 0
Baseline and Week 24
Secondary outcome [5] 0 0
Change From Baseline to the 28-day Average of Daily Peak Nasal Inspiratory Flow (PNIF) at Week 24
Timepoint [5] 0 0
Baseline and Week 24
Secondary outcome [6] 0 0
Change From Baseline in Sino-Nasal Outcome Test (SNOT-22) Total Score at Week 24
Timepoint [6] 0 0
Baseline and Week 24
Secondary outcome [7] 0 0
Plasma Concentration of Brensocatib
Timepoint [7] 0 0
Pre-dose and at multiple timepoints post-dose up to Week 24
Secondary outcome [8] 0 0
Percentage of Participants who Experienced at Least One Adverse Event (AE)
Timepoint [8] 0 0
Up to 28 weeks

Eligibility
Key inclusion criteria
* Participants who have at least a 12-week history before Screening Visit of CRSsNP and confirmed by endoscopy at Visit 1 (Screening).
* Participants must have a NCS of =2 at Visit 1 (Screening Visit) and Visit 2 (weekly average score).
* Participants must have sTSS (nasal congestion [NC], anterior/posterior rhinorrhea, facial pain/pressure) =5 at Visit 1 (Screening) and at Visit 2 (Baseline) (average score in the week prior to randomization).
* Participants who have at least 1 of the 3 following features:

1. Previous sinonasal surgery for CRS, including but not limited to fenestrated endoscopic sinus surgery and balloon sinuplasty.
2. Received medical treatment with systemic corticosteroids (SCS) to treat symptoms of CRS as defined by any dose and duration within 1 year of Screening Visit or intolerance/contraindication to SCS.
3. Received a course of antibiotics to treat symptoms of CRS within 1 year before the Screening Visit.
* Participants who have a blood eosinophil count =750 cells/microliter (µL) at Visit 1 (Screening).
* Participants who have bilateral inflammation of paranasal sinuses in the CT scan performed during Screening and bilateral ethmoid and/or maxillary opacification before randomization as confirmed by the central reader.
* Participants who have a SNOT-22 score of =20 at Visit 1 (Screening) and Visit 2 (Baseline).
* Participants who have received a stable daily dose regimen of MFNS for at least 4 weeks before Visit 2 (Baseline).
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Diagnosis of unilateral or bilateral chronic rhinosinusitis with nasal polyps (CRSwNP).
* Clinical diagnosis of cystic fibrosis (CF) or primary ciliary dyskinesia.
* Scheduled sinus surgery at any time during the study.
* Participants who have had nasal surgery within 4 weeks before Visit 1 (Screening) and during the Screening Period.
* Significant oral maxillofacial structural abnormalities or severe septal deviation.
* Participants with radiological suspicion or confirmed invasive fungal rhinosinusitis, odontogenic sinusitis, osteomas, or nasal tumors.
* Participants with acute change in symptoms consistent with acute rhinosinusitis.
* Participants with seasonal allergic rhinitis whose symptoms coincide with the treatment period of the study.
* Participants with moderate to severe atopic dermatitis requiring treatment with high potency topical steroids or topical calcineurin inhibitors or biologics.
* Clinical diagnosis of Papillon-Lefèvre syndrome. Note: Other inclusion/exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/09/2025
Actual
Sample size
Target
270
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,WA
Recruitment hospital [1] 0 0
AUS004 - Birtinya
Recruitment hospital [2] 0 0
AUS001 - Herston
Recruitment hospital [3] 0 0
AUS002 - Spearwood
Recruitment postcode(s) [1] 0 0
4575 - Birtinya
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
6163 - Spearwood
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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Florida
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Illinois
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Indiana
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United States of America
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Louisiana
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United States of America
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Maryland
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Missouri
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Oklahoma
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Pennsylvania
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South Carolina
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Texas
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autónoma De BuenosAires
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Argentina
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Mendoza
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Argentina
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Santa Fe
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Tucumán
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Argentina
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Mar del Plata
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Belgium
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Oost-Vlaanderen
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Belgium
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Erpent
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Belgium
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Sint-Lambrechts-Woluwe
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Bulgaria
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Sofia-Grad
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Bulgaria
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Plovdiv
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Bulgaria
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Stara Zagora
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Ontario
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Quebec
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Czechia
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Olomoucký Kraj
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Czechia
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Pardubický Kraj
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Czechia
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Nový Hradec Králové
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Czechia
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Prague
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Capital
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Central Jutland
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Zeeland
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France
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Bouches-du-Rhône
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France
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Loire-Atlantique
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France
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Vendée
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Germany
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Hessen
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Germany
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Sachsen
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Germany
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Schleswig-Holstein
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Germany
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Thüringen
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Germany
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Berlin
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Germany
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Dresden
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Hungary
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Baranya
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Italy
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Lombardia
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Italy
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Sardegna
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Italy
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Toscana
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Poland
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Dolnoslaskie
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Lubelskie
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Malopolskie
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Mazowieckie
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Podlaskie
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Slaskie
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Poland
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Wielkopolskie
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Poland
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Warszawa
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Portugal
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Braga
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Portugal
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Lisboa
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Portugal
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Porto
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Portugal
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Aveiro
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Spain
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Cantabria
Country [61] 0 0
Spain
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Cádiz
Country [62] 0 0
Spain
State/province [62] 0 0
Málaga
Country [63] 0 0
Spain
State/province [63] 0 0
Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Insmed Incorporated
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Insmed Medical Information
Address 0 0
Country 0 0
Phone 0 0
1-844-446-7633
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06013241