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Chronic Rhinosinusitis Without Nasal PolypsPhase 2BiRChNCT06013241

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

A Phase 2 study testing Brensocatib and Mometasone furoate nasal spray (MFNS) in people with Chronic Rhinosinusitis Without Nasal Polyps, run by Insmed Incorporated at 100 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Brensocatib and Mometasone furoate nasal spray (MFNS)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
288 participants
Where
100 sitesin 15 countries
Study dates
30 Oct 2023to 30 Oct 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Previous sinonasal surgery for CRS, including but not limited to fenestrated endoscopic sinus surgery and balloon sinuplasty.
  • 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.
Show all 11Show fewer
  • 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).

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

100 sites in 15 countries.

100 sites in 15 countries

United States27 sites

  • USA026

    Baltimore, Maryland, 21287

  • USA016

    Boca Raton, Florida, 33487

  • USA023

    Charleston, South Carolina, 29425

  • USA031

    Chicago, Illinois, 60611

  • USA021

    Chicago, Illinois, 60612

  • USA011

    Columbia, Missouri, 65212

  • USA025

    Dallas, Texas, 75231

  • USA037

    Fredericksburg, Texas, 78624

  • USA015

    Hershey, Pennsylvania, 17033

  • USA019

    Hollywood, Florida, 33024

  • USA029

    Houston, Texas, 77022

  • USA018

    Houston, Texas, 77030

  • USA035

    Mandeville, Louisiana, 70471

  • USA001

    Miami, Florida, 33135

  • USA003

    New Albany, Indiana, 47150

  • USA033

    New York, New York, 10016

  • USA005

    Norfolk, Virginia, 23507

  • USA022

    North Charleston, South Carolina, 29406

  • USA002

    Roseville, California, 95661

  • USA030

    San Antonio, Texas, 78258

  • USA024

    St Louis, Missouri, 63141

  • USA009

    Tampa, Florida, 33613

  • USA038

    Tomball, Texas, 77375

  • USA034

    Tucson, Arizona, 85704

  • USA028

    Tulsa, Oklahoma, 74132

  • USA004

    Tulsa, Oklahoma, 74136

  • USA006

    Upland, California, 91786

Other trials in United States

Argentina17 sites

  • ARG005

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1121ABE

  • ARG012

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1414

  • ARG011

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1425

  • ARG017

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1426ABP

  • ARG015

    La Plata, Buenos Aires, B1900BNN

  • ARG001

    La Plata, Buenos Aires, B1900

  • ARG006

    Lobos, Buenos Aires, B7240AAN

  • ARG002

    Mar del Plata, B7602DCK

  • ARG014

    Mendoza, 5500

  • ARG003

    Mendoza, M5500CCG

  • ARG007

    Rosario, Santa Fe Province, S2013DBS

  • ARG010

    Rosario, Santa Fe Province, S2013DTC

  • ARG004

    Rosario, Santa Fe Province, S2013

  • ARG016

    Rosario, S2002KDT

  • ARG009

    San Miguel de Tucumán, Tucumán Province, T4000AXL

  • ARG013

    San Rafael, Mendoza Province, M5600IBJ

  • ARG008

    Santa Fe, 3000

Other trials in Argentina

Poland10 sites

  • POL004

    Bialystok, Podlaskie Voivodeship, 15-276

  • POL006

    Katowice, Silesian Voivodeship, 40-611

  • POL005

    Krakow, Lesser Poland Voivodeship, 30-033

  • POL003

    Lublin, Lublin Voivodeship, 20-954

  • POL002

    Poznan, Greater Poland Voivodeship, 60-309

  • POL010

    Poznan, Greater Poland Voivodeship, 60-693

  • POL001

    Warsaw, Masovian Voivodeship, 00-189

  • POL008

    Warsaw, 04-141

  • POL007

    Wieliczka, Lesser Poland Voivodeship, 32-020

  • POL009

    Wroclaw, Lower Silesian Voivodeship, 52-416

Other trials in Poland

Germany7 sites

  • GER007

    Berlin, 10117

  • GER001

    Dresden, 01307

  • GER005

    Jena, Thuringia, 07747

  • GER009

    Leipzig, Saxony, 04103

  • GER008

    Lübeck, Schleswig-Holstein, 23562

  • GER003

    Mittweida, Saxony, 09648

  • GER004

    Wiesbaden, Hesse, 65183

Other trials in Germany

Canada6 sites

  • CAN006

    London, Ontario, N6A 4V2

  • CAN005

    Montreal, Quebec, H4A 3J1

  • CAN001

    Québec, Quebec, G1S 4L8

  • CAN002

    Québec, G1V 4W2

  • CAN007

    Toronto, Ontario, M5G 1X5

  • CAN003

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

Portugal5 sites

  • PRT004

    Aveiro, 3814-501

  • PRT002

    Braga, 4710

  • PRT001

    Guimarães, Braga District, 4835-044

  • PRT003

    Lisbon, Lisbon District, 1349-019

  • PRT005

    Senhora da Hora, Porto District, 4464-513

Other trials in Portugal

Czechia4 sites

  • CZE005

    Nový Hradec Králové, 500 05

  • CZE002

    Olomouc, Olomouc Region, 779 00

  • CZE003

    Pardubice, Pardubice Region, 532 03

  • CZE004

    Prague, 140 59

Other trials in Czechia

Denmark4 sites

  • DNK003

    Aarhus C, Central Jutland, 8000

  • DNK004

    Hillerød, Capital, 3400

  • DNK001

    København Ø, Capital, 2100

  • DNK002

    Køge, Region Sjælland, 4600

Other trials in Denmark

France4 sites

  • FRA004

    La Roche-sur-Yon, Vendée, 85925

  • FRA003

    Marseille, Bouches-du-Rhône, 13010

  • FRA001

    Nantes, Loire-Atlantique, 44000

  • FRA002

    Strasbourg, Bas-Rhin, 67200

Other trials in France

Spain4 sites

  • ESP002

    Jerez de la Frontera, Cádiz, 11407

  • ESP004

    Málaga, Málaga, 29009

  • ESP003

    Santander, Cantabria, 39008

  • ESP001

    Seville, 41009

Other trials in Spain

Belgium3 sites

  • BEL002

    Erpent, 5101

  • BEL001

    Ghent, Oost-Vlaanderen, 9000

  • BEL003

    Woluwe-Saint-Lambert, 1200

Other trials in Belgium

Bulgaria3 sites

  • BGR003

    Plovdiv, 4001

  • BGR005

    Sofia, Sofia-Grad, 1606

  • BGR006

    Stara Zagora, 6000

Other trials in Bulgaria

Italy3 sites

  • ITA003

    Pisa, Tuscany, 56124

  • ITA001

    Rozzano, Lombardy, 20089

  • ITA002

    Sassari, Sardinia, 07100

Other trials in Italy

Australia2 sites

  • AUS001

    Herston, Queensland, 4029

  • AUS002

    Spearwood, Western Australia, 6163

Other trials in Australia

Hungary1 site

  • HUN003

    Pécs, Baranya, 7621

Other trials in Hungary

About this study

Official 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

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.

Being tested
Brensocatib, Placebo, Mometasone furoate nasal spray (MFNS)
Keywords
CRSsNP

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BrensocatibDrug

    Also called INS1007

    Film-coated tablet.

  • PlaceboDrug

    Film-coated tablet.

  • Mometasone furoate nasal spray (MFNS)Drug

    Nasal spray suspension.

Study groups in NCT06013241
Study groupRoleWhat they receive
Brensocatib 40 mgExperimentalParticipants received brensocatib 40 milligrams (mg) tablet, orally, once daily (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.
Receives: Drug: Brensocatib; Drug: Mometasone furoate nasal spray (MFNS)
Brensocatib 10 mgExperimentalParticipants received 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.
Receives: Drug: Brensocatib; Drug: Mometasone furoate nasal spray (MFNS)
PlaceboPlacebo comparatorParticipants received 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.
Receives: Drug: Placebo; Drug: Mometasone furoate nasal spray (MFNS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline to the 28-day Average of Daily Sinus Total Symptom Score (sTSS) at Week 24

    Measured: Baseline and Week 24

Secondary outcomes (8)

  1. Change From Baseline in Percentage of Sinus (Maxillary and Ethmoid) Opacification as Measured by Volumetry at 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.

    Measured: Baseline and Week 24

  2. Change From Baseline in Modified Lund-MacKay (LMK) Computed Tomography (CT) Score at Week 24

    Measured: Baseline and Week 24

  3. 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

    Measured: Baseline up to Week 24

  4. Change From Baseline to the 28-day Average of Daily Nasal Congestion Score (NCS) at Week 24

    Measured: Baseline and Week 24

  5. Change From Baseline to the 28-day Average of Daily Peak Nasal Inspiratory Flow (PNIF) at Week 24

    Measured: Baseline and Week 24

  6. Change From Baseline in Sino-Nasal Outcome Test (SNOT-22) Total Score at Week 24

    Measured: Baseline and Week 24

  7. Plasma Concentration of Brensocatib

    Measured: Pre-dose and at multiple timepoints post-dose up to Week 24

  8. Percentage of Participants who Experienced at Least One Adverse Event (AE)

    Determination of the safety and tolerability of brensocatib compared with placebo.

    Measured: Up to 28 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2023
  2. Study start30 Oct 2023
  3. Primary completion30 Sep 2025
  4. Study completion30 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
288 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06013241
Sponsor's protocol ID
INS1007-221
Other IDs
2022-502481-24-00
Acronym
BiRCh
Status last verified
Nov 2026
First submitted
22 Aug 2023
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Brensocatib and Mometasone furoate nasal spray (MFNS) in people with Chronic Rhinosinusitis Without Nasal Polyps, run by Insmed Incorporated at 100 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 100 sites in United States, Argentina, Poland, Germany, Canada and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to the 28-day Average of Daily Sinus Total Symptom Score (sTSS) at Week 24 (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06013241.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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