A Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
NCT ID: NCT06013241
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
288 participants
INTERVENTIONAL
2023-10-30
2025-10-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Brensocatib
Film-coated tablet.
Mometasone furoate nasal spray (MFNS)
Nasal spray suspension.
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.
Brensocatib
Film-coated tablet.
Mometasone furoate nasal spray (MFNS)
Nasal spray suspension.
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.
Placebo
Film-coated tablet.
Mometasone furoate nasal spray (MFNS)
Nasal spray suspension.
Interventions
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Brensocatib
Film-coated tablet.
Placebo
Film-coated tablet.
Mometasone furoate nasal spray (MFNS)
Nasal spray suspension.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Insmed Incorporated
INDUSTRY
Responsible Party
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Locations
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USA034
Tucson, Arizona, United States
USA002
Roseville, California, United States
USA006
Upland, California, United States
USA016
Boca Raton, Florida, United States
USA019
Hollywood, Florida, United States
USA001
Miami, Florida, United States
USA009
Tampa, Florida, United States
USA031
Chicago, Illinois, United States
USA021
Chicago, Illinois, United States
USA003
New Albany, Indiana, United States
USA035
Mandeville, Louisiana, United States
USA026
Baltimore, Maryland, United States
USA011
Columbia, Missouri, United States
USA024
St Louis, Missouri, United States
USA033
New York, New York, United States
USA028
Tulsa, Oklahoma, United States
USA004
Tulsa, Oklahoma, United States
USA015
Hershey, Pennsylvania, United States
USA023
Charleston, South Carolina, United States
USA022
North Charleston, South Carolina, United States
USA025
Dallas, Texas, United States
USA037
Fredericksburg, Texas, United States
USA029
Houston, Texas, United States
USA018
Houston, Texas, United States
USA030
San Antonio, Texas, United States
USA038
Tomball, Texas, United States
USA005
Norfolk, Virginia, United States
ARG015
La Plata, Buenos Aires, Argentina
ARG001
La Plata, Buenos Aires, Argentina
ARG006
Lobos, Buenos Aires, Argentina
ARG005
Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina
ARG012
Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina
ARG011
Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina
ARG017
Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina
ARG013
San Rafael, Mendoza Province, Argentina
ARG007
Rosario, Santa Fe Province, Argentina
ARG010
Rosario, Santa Fe Province, Argentina
ARG004
Rosario, Santa Fe Province, Argentina
ARG009
San Miguel de Tucumán, Tucumán Province, Argentina
ARG002
Mar del Plata, , Argentina
ARG014
Mendoza, , Argentina
ARG003
Mendoza, , Argentina
ARG016
Rosario, , Argentina
ARG008
Santa Fe, , Argentina
AUS001
Herston, Queensland, Australia
AUS002
Spearwood, Western Australia, Australia
BEL001
Ghent, Oost-Vlaanderen, Belgium
BEL002
Erpent, , Belgium
BEL003
Woluwe-Saint-Lambert, , Belgium
BGR005
Sofia, Sofia-Grad, Bulgaria
BGR003
Plovdiv, , Bulgaria
BGR006
Stara Zagora, , Bulgaria
CAN003
Vancouver, British Columbia, Canada
CAN006
London, Ontario, Canada
CAN007
Toronto, Ontario, Canada
CAN005
Montreal, Quebec, Canada
CAN001
Québec, Quebec, Canada
CAN002
Québec, , Canada
CZE002
Olomouc, Olomoucký kraj, Czechia
CZE003
Pardubice, Pardubický kraj, Czechia
CZE005
Nový Hradec Králové, , Czechia
CZE004
Prague, , Czechia
DNK004
Hillerød, Capital, Denmark
DNK001
København Ø, Capital, Denmark
DNK003
Aarhus C, Central Jutland, Denmark
DNK002
Køge, Zeeland, Denmark
FRA002
Strasbourg, Bas-Rhin, France
FRA003
Marseille, Bouches-du-Rhône, France
FRA001
Nantes, Loire-Atlantique, France
FRA004
La Roche-sur-Yon, Vendée, France
GER004
Wiesbaden, Hesse, Germany
GER009
Leipzig, Saxony, Germany
GER003
Mittweida, Saxony, Germany
GER008
Lübeck, Schleswig-Holstein, Germany
GER005
Jena, Thuringia, Germany
GER007
Berlin, , Germany
GER001
Dresden, , Germany
HUN003
Pécs, Baranya, Hungary
ITA001
Rozzano, Lombardy, Italy
ITA002
Sassari, Sardinia, Italy
ITA003
Pisa, Tuscany, Italy
POL002
Poznan, Greater Poland Voivodeship, Poland
POL010
Poznan, Greater Poland Voivodeship, Poland
POL005
Krakow, Lesser Poland Voivodeship, Poland
POL007
Wieliczka, Lesser Poland Voivodeship, Poland
POL009
Wroclaw, Lower Silesian Voivodeship, Poland
POL003
Lublin, Lublin Voivodeship, Poland
POL001
Warsaw, Masovian Voivodeship, Poland
POL004
Bialystok, Podlaskie Voivodeship, Poland
POL006
Katowice, Silesian Voivodeship, Poland
POL008
Warsaw, , Poland
PRT001
Guimarães, Braga District, Portugal
PRT003
Lisbon, Lisbon District, Portugal
PRT005
Senhora da Hora, Porto District, Portugal
PRT004
Aveiro, , Portugal
PRT002
Braga, , Portugal
ESP003
Santander, Cantabria, Spain
ESP002
Jerez de la Frontera, Cádiz, Spain
ESP004
Málaga, Málaga, Spain
ESP001
Seville, , Spain
Countries
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Related Links
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Other Identifiers
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2022-502481-24-00
Identifier Type: OTHER
Identifier Source: secondary_id
INS1007-221
Identifier Type: -
Identifier Source: org_study_id