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

November 7, 2025 updated by: Insmed Incorporated

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

The primary purpose of the study is to evaluate the efficacy of brensocatib at 10 and 40 milligrams (mg) once daily (QD) compared with placebo in improving clinical symptoms of CRSsNP.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
288

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Mar del Plata, Argentina, B7602DCK
        • ARG002
      • Mendoza, Argentina, 5500
        • ARG014
      • Mendoza, Argentina, M5500CCG
        • ARG003
      • Rosario, Argentina, S2002KDT
        • ARG016
      • Santa Fe, Argentina, 3000
        • ARG008
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina, B1900BNN
        • ARG015
      • La Plata, Buenos Aires, Argentina, B1900
        • ARG001
      • Lobos, Buenos Aires, Argentina, B7240AAN
        • ARG006
    • Ciudad Autónoma de BuenosAires
      • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1121ABE
        • ARG005
      • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1414
        • ARG012
      • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1425
        • ARG011
      • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1426ABP
        • ARG017
    • Mendoza Province
      • San Rafael, Mendoza Province, Argentina, M5600IBJ
        • ARG013
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2013DBS
        • ARG007
      • Rosario, Santa Fe Province, Argentina, S2013DTC
        • ARG010
      • Rosario, Santa Fe Province, Argentina, S2013
        • ARG004
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
        • ARG009
  • Australia
    • Queensland
      • Herston, Queensland, Australia, 4029
        • AUS001
    • Western Australia
      • Spearwood, Western Australia, Australia, 6163
        • AUS002
  • Belgium
      • Erpent, Belgium, 5101
        • BEL002
      • Woluwe-Saint-Lambert, Belgium, 1200
        • BEL003
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • BEL001
  • Bulgaria
      • Plovdiv, Bulgaria, 4001
        • BGR003
      • Stara Zagora, Bulgaria, 6000
        • BGR006
    • Sofia-Grad
      • Sofia, Sofia-Grad, Bulgaria, 1606
        • BGR005
  • Canada
      • Québec, Canada, G1V 4W2
        • CAN002
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • CAN003
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • CAN006
      • Toronto, Ontario, Canada, M5G 1X5
        • CAN007
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • CAN005
      • Québec, Quebec, Canada, G1S 4L8
        • CAN001
  • Czechia
      • Nový Hradec Králové, Czechia, 500 05
        • CZE005
      • Prague, Czechia, 140 59
        • CZE004
    • Olomoucký kraj
      • Olomouc, Olomoucký kraj, Czechia, 779 00
        • CZE002
    • Pardubický kraj
      • Pardubice, Pardubický kraj, Czechia, 532 03
        • CZE003
  • Denmark
    • Capital
      • Hillerød, Capital, Denmark, 3400
        • DNK004
      • København Ø, Capital, Denmark, 2100
        • DNK001
    • Central Jutland
      • Aarhus C, Central Jutland, Denmark, 8000
        • DNK003
    • Zeeland
      • Køge, Zeeland, Denmark, 4600
        • DNK002
  • France
    • Bas-Rhin
      • Strasbourg, Bas-Rhin, France, 67200
        • FRA002
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13010
        • FRA003
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44000
        • FRA001
    • Vendée
      • La Roche-sur-Yon, Vendée, France, 85925
        • FRA004
  • Germany
      • Berlin, Germany, 10117
        • GER007
      • Dresden, Germany, 01307
        • GER001
    • Hesse
      • Wiesbaden, Hesse, Germany, 65183
        • GER004
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • GER009
      • Mittweida, Saxony, Germany, 09648
        • GER003
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23562
        • GER008
    • Thuringia
      • Jena, Thuringia, Germany, 07747
        • GER005
  • Hungary
    • Baranya
      • Pécs, Baranya, Hungary, 7621
        • HUN003
  • Italy
    • Lombardy
      • Rozzano, Lombardy, Italy, 20089
        • ITA001
    • Sardinia
      • Sassari, Sardinia, Italy, 07100
        • ITA002
    • Tuscany
      • Pisa, Tuscany, Italy, 56124
        • ITA003
  • Poland
      • Warsaw, Poland, 04-141
        • POL008
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-309
        • POL002
      • Poznan, Greater Poland Voivodeship, Poland, 60-693
        • POL010
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-033
        • POL005
      • Wieliczka, Lesser Poland Voivodeship, Poland, 32-020
        • POL007
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 52-416
        • POL009
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-954
        • POL003
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 00-189
        • POL001
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-276
        • POL004
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-611
        • POL006
  • Portugal
      • Aveiro, Portugal, 3814-501
        • PRT004
      • Braga, Portugal, 4710
        • PRT002
    • Braga District
      • Guimarães, Braga District, Portugal, 4835-044
        • PRT001
    • Lisbon District
      • Lisbon, Lisbon District, Portugal, 1349-019
        • PRT003
    • Porto District
      • Senhora da Hora, Porto District, Portugal, 4464-513
        • PRT005
  • Spain
      • Seville, Spain, 41009
        • ESP001
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • ESP003
    • Cádiz
      • Jerez de la Frontera, Cádiz, Spain, 11407
        • ESP002
    • Málaga
      • Málaga, Málaga, Spain, 29009
        • ESP004
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85704
        • USA034
    • California
      • Roseville, California, United States, 95661
        • USA002
      • Upland, California, United States, 91786
        • USA006
    • Florida
      • Boca Raton, Florida, United States, 33487
        • USA016
      • Hollywood, Florida, United States, 33024
        • USA019
      • Miami, Florida, United States, 33135
        • USA001
      • Tampa, Florida, United States, 33613
        • USA009
    • Illinois
      • Chicago, Illinois, United States, 60611
        • USA031
      • Chicago, Illinois, United States, 60612
        • USA021
    • Indiana
      • New Albany, Indiana, United States, 47150
        • USA003
    • Louisiana
      • Mandeville, Louisiana, United States, 70471
        • USA035
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • USA026
    • Missouri
      • Columbia, Missouri, United States, 65212
        • USA011
      • St Louis, Missouri, United States, 63141
        • USA024
    • New York
      • New York, New York, United States, 10016
        • USA033
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74132
        • USA028
      • Tulsa, Oklahoma, United States, 74136
        • USA004
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • USA015
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • USA023
      • North Charleston, South Carolina, United States, 29406
        • USA022
    • Texas
      • Dallas, Texas, United States, 75231
        • USA025
      • Fredericksburg, Texas, United States, 78624
        • USA037
      • Houston, Texas, United States, 77030
        • USA018
      • Houston, Texas, United States, 77022
        • USA029
      • San Antonio, Texas, United States, 78258
        • USA030
      • Tomball, Texas, United States, 77375
        • USA038
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • USA005

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 (Baseline; average score in the week prior to randomization).
  • 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).

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Brensocatib
Film-coated tablet.
Other Names:
  • INS1007
Drug: Mometasone furoate nasal spray (MFNS)
Nasal spray suspension.
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.
Drug: Brensocatib
Film-coated tablet.
Other Names:
  • INS1007
Drug: Mometasone furoate nasal spray (MFNS)
Nasal spray suspension.
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.
Drug: Mometasone furoate nasal spray (MFNS)
Nasal spray suspension.
Drug: Placebo
Film-coated tablet.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change From Baseline to the 28-day Average of Daily Sinus Total Symptom Score (sTSS) at Week 24
Time Frame: Baseline and Week 24
Baseline and Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Percentage of Sinus (Maxillary and Ethmoid) Opacification as Measured by Volumetry at Week 24
Time Frame: Baseline and Week 24
The computed tomography (CT) scan performed during Screening (considered as Baseline) and at Week 24 will be used for the volumetric assessment of maxillary and ethmoid sinus opacification.
Baseline and Week 24
Change From Baseline in Modified Lund-MacKay (LMK) Computed Tomography (CT) Score at Week 24
Time Frame: Baseline and Week 24
Baseline and Week 24
Change From Baseline to the 28-day Average of Daily Nasal Congestion Score (NCS) at Week 24
Time Frame: Baseline and Week 24
Baseline and Week 24
Change From Baseline to the 28-day Average of Daily Peak Nasal Inspiratory Flow (PNIF) at Week 24
Time Frame: Baseline and Week 24
Baseline and Week 24
Change From Baseline in Sino-Nasal Outcome Test (SNOT-22) Total Score at Week 24
Time Frame: Baseline and Week 24
Baseline and Week 24
Plasma Concentration of Brensocatib
Time Frame: Pre-dose and at multiple timepoints post-dose up to Week 24
Pre-dose and at multiple timepoints post-dose up to Week 24
Percentage of Participants who Experienced at Least One Adverse Event (AE)
Time Frame: Up to 28 weeks
Determination of the safety and tolerability of brensocatib compared with placebo.
Up to 28 weeks
Proportion of Participants Requiring Rescue (Antibiotics, Systemic Corticosteroids [SCS], and/or Nasal Surgery) due to Worsening of any Chronic Rhinosinusitis (CRS) Symptoms up to Week 24
Time Frame: Baseline up to Week 24
Baseline up to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Insmed Incorporated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INS1007-221
  • 2022-502481-24-00 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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