Phase
Condition
Sinus Infections
Rhinitis, Allergic, Perennial
Soft Tissue Infections
Treatment
Mometasone furoate nasal spray (MFNS)
Placebo
Brensocatib
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants who have at least a 12-week history before Screening Visit of CRSsNPand 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; averagescore 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 fenestratedendoscopic sinus surgery and balloon sinuplasty.
Received medical treatment with systemic corticosteroids (SCS) to treatsymptoms of CRS as defined by any dose and duration within 1 year of ScreeningVisit or intolerance/contraindication to SCS.
Received a course of antibiotics to treat symptoms of CRS within 1 year beforethe 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 scanperformed during Screening and bilateral ethmoid and/or maxillary opacificationbefore 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 4weeks before Visit 2 (Baseline).
Exclusion
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 fungalrhinosinusitis, 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 thetreatment period of the study.
Participants with moderate to severe atopic dermatitis requiring treatment with highpotency topical steroids or topical calcineurin inhibitors or biologics.
Clinical diagnosis of Papillon-Lefèvre syndrome.
Note: Other inclusion/exclusion criteria may apply.
Study Design
Connect with a study center
ARG001
La Plata, Buenos Aires B1900
ArgentinaSite Not Available
ARG015
La Plata, Buenos Aires B1900BNN
ArgentinaSite Not Available
ARG006
Lobos, Buenos Aires B7240AAN
ArgentinaSite Not Available
ARG005
Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires C1121ABE
ArgentinaSite Not Available
ARG011
Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires C1425
ArgentinaSite Not Available
ARG012
Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires C1414
ArgentinaSite Not Available
ARG017
Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires C1426ABP
ArgentinaSite Not Available
ARG013
San Rafael, Mendoza M5600IBJ
ArgentinaSite Not Available
ARG004
Rosario, Santa Fe S2013
ArgentinaSite Not Available
ARG007
Rosario, Santa Fe S2013DBS
ArgentinaSite Not Available
ARG010
Rosario, Santa Fe S2013DTC
ArgentinaSite Not Available
ARG009
San Miguel De Tucumán, Tucumán T4000AXL
ArgentinaSite Not Available
ARG002
Mar del Plata, B7602DCK
ArgentinaSite Not Available
ARG003
Mendoza, M5500CCG
ArgentinaSite Not Available
ARG014
Mendoza, 5500
ArgentinaSite Not Available
ARG016
Rosario, S2002KDT
ArgentinaSite Not Available
ARG008
Santa Fe, 3000
ArgentinaSite Not Available
AUS004
Birtinya, Queensland 4575
AustraliaSite Not Available
AUS001
Herston, Queensland 4029
AustraliaSite Not Available
AUS003
Melbourne, Victoria 3000
AustraliaSite Not Available
AUS002
Spearwood, Western Australia 6163
AustraliaSite Not Available
BEL002
Faulx-les-Tombes, Namur 5340
BelgiumSite Not Available
BEL002
Faux-Les-Tombes, Namur 5340
BelgiumSite Not Available
BEL001
Gent, Oost-Vlaanderen 9000
BelgiumSite Not Available
BEL002
Erpent, 5101
BelgiumSite Not Available
BEL003
Sint-Lambrechts-Woluwe, 1200
BelgiumSite Not Available
BEL003
Woluwe-Saint-Lambert, 1200
BelgiumSite Not Available
BGR002
Sofia, Sofia-Grad 1527
BulgariaSite Not Available
BGR005
Sofia, Sofia-Grad 1606
BulgariaSite Not Available
BGR003
Plovdiv, 4001
BulgariaSite Not Available
BGR001
Stara Zagora, 6003
BulgariaSite Not Available
BGR006
Stara Zagora, 6000
BulgariaSite Not Available
CAN003
Vancouver, British Columbia V6Z 1Y6
CanadaSite Not Available
CAN006
London, Ontario N6A 4V2
CanadaSite Not Available
CAN007
Toronto, Ontario M5G 1X5
CanadaSite Not Available
CAN005
Montreal, Quebec H4A 3J1
CanadaSite Not Available
CAN001
Quebec City, Quebec G1S 4L8
CanadaSite Not Available
CAN002
Quebec, G1V 4W2
CanadaSite Not Available
CZE002
Olomouc, Olomoucký Kraj 779 00
CzechiaSite Not Available
CZE003
Pardubice, Pardubický Kraj 532 03
CzechiaSite Not Available
CZE005
Nový Hradec Králové, 500 05
CzechiaSite Not Available
CZE004
Prague, 140 59
CzechiaSite Not Available
DNK004
Hillerød, Capital 3400
DenmarkSite Not Available
DNK001
København Ø, Capital 2100
DenmarkSite Not Available
DNK003
Aarhus C, Central Jutland 8000
DenmarkSite Not Available
DNK002
Køge, Zeeland 4600
DenmarkSite Not Available
FRA002
Strasbourg, Bas-Rhin 67200
FranceSite Not Available
FRA003
Marseille, Bouches-du-Rhône 13010
FranceSite Not Available
FRA001
Nantes, Loire-Atlantique 44000
FranceSite Not Available
FRA004
La Roche-sur-Yon, Vendée 85925
FranceSite Not Available
GER004
Wiesbaden, Hessen 65183
GermanySite Not Available
GER009
Leipzig, Sachsen 04103
GermanySite Not Available
GER003
Mittweida, Sachsen 09648
GermanySite Not Available
GER008
Lübeck, Schleswig-Holstein 23562
GermanySite Not Available
GER005
Jena, Thüringen 07747
GermanySite Not Available
GER007
Berlin, 10117
GermanySite Not Available
GER001
Dresden, 01307
GermanySite Not Available
HUN003
Pécs, Baranya 7621
HungarySite Not Available
ITA001
Rozzano, Lombardia 20089
ItalySite Not Available
ITA002
Sassari, Sardegna 07100
ItalySite Not Available
ITA003
Pisa, Toscana 56124
ItalySite Not Available
ITA004
Siena, Toscana 53100
ItalySite Not Available
POL009
Wroclaw, Dolnoslaskie 52-416
PolandSite Not Available
POL003
Lublin, Lubelskie 20-954
PolandSite Not Available
POL005
Kraków, Malopolskie 30-033
PolandSite Not Available
POL007
Wieliczka, Malopolskie 32-020
PolandSite Not Available
POL001
Warszawa, Mazowieckie 00-189
PolandSite Not Available
POL004
Białystok, Podlaskie 15-276
PolandSite Not Available
POL006
Katowice, Slaskie 40-611
PolandSite Not Available
POL002
Poznan, Wielkopolskie 60-309
PolandSite Not Available
POL010
Poznan, Wielkopolskie 60-693
PolandSite Not Available
POL008
Warszawa, 04-141
PolandSite Not Available
PRT001
Guimarães, Braga 4835-044
PortugalSite Not Available
PRT003
Lisbon, Lisboa 1349-019
PortugalSite Not Available
PRT005
Senhora Da Hora, Porto 4464-513
PortugalSite Not Available
PRT004
Aveiro, 3814-501
PortugalSite Not Available
PRT002
Braga, 4710
PortugalSite Not Available
ESP003
Santander, Cantabria 39008
SpainSite Not Available
ESP002
Jerez de la Frontera, Cádiz 11407
SpainSite Not Available
ESP004
Malaga, Málaga 29009
SpainSite Not Available
ESP001
Sevilla, 41009
SpainSite Not Available
USA034
Tucson, Arizona 85704
United StatesSite Not Available
USA002
Roseville, California 95661
United StatesSite Not Available
USA006
Upland, California 91786
United StatesSite Not Available
USA010
Colorado Springs, Colorado 80909-1177
United StatesSite Not Available
USA016
Boca Raton, Florida 33487
United StatesSite Not Available
USA019
Hollywood, Florida 33024
United StatesSite Not Available
USA001
Miami, Florida 33135
United StatesSite Not Available
USA009
Tampa, Florida 33613
United StatesSite Not Available
USA021
Chicago, Illinois 60612
United StatesSite Not Available
USA031
Chicago, Illinois 60611
United StatesSite Not Available
USA036
Chicago, Illinois 60657
United StatesSite Not Available
USA003
New Albany, Indiana 47150
United StatesSite Not Available
USA035
Mandeville, Louisiana 70471
United StatesSite Not Available
USA026
Baltimore, Maryland 21287
United StatesSite Not Available
USA011
Columbia, Missouri 65212
United StatesSite Not Available
USA024
Saint Louis, Missouri 63141
United StatesSite Not Available
USA033
New York, New York 10016
United StatesSite Not Available
USA004
Tulsa, Oklahoma 74136
United StatesSite Not Available
USA028
Tulsa, Oklahoma 74132
United StatesSite Not Available
USA015
Hershey, Pennsylvania 17033
United StatesSite Not Available
USA023
Charleston, South Carolina 29425
United StatesSite Not Available
USA022
North Charleston, South Carolina 29406
United StatesSite Not Available
USA025
Dallas, Texas 75231
United StatesSite Not Available
USA037
Fredericksburg, Texas 78624
United StatesSite Not Available
USA018
Houston, Texas 77030
United StatesSite Not Available
USA029
Houston, Texas 77022
United StatesSite Not Available
USA030
San Antonio, Texas 78258
United StatesSite Not Available
USA038
Tomball, Texas 77375
United StatesSite Not Available
USA005
Norfolk, Virginia 23507
United StatesSite Not Available
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