A Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
- Conditions
- Chronic Rhinosinusitis Without Nasal Polyps
- Interventions
- Registration Number
- NCT06013241
- Lead Sponsor
- Insmed Incorporated
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 288
-
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.
- 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).
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Brensocatib 40 mg Mometasone furoate nasal spray (MFNS) 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 10 mg Mometasone furoate nasal spray (MFNS) 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 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. Brensocatib 10 mg Brensocatib 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 Mometasone furoate nasal spray (MFNS) 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. Brensocatib 40 mg Brensocatib 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.
- Primary Outcome Measures
Name Time Method Change From Baseline to the 28-day Average of Daily Sinus Total Symptom Score (sTSS) at Week 24 Baseline and Week 24
- Secondary Outcome Measures
Name Time Method Percentage of Participants who Experienced at Least One Adverse Event (AE) Up to 28 weeks Determination of the safety and tolerability of brensocatib compared with placebo.
Change From Baseline in Percentage of Sinus (Maxillary and Ethmoid) Opacification as Measured by Volumetry at Week 24 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.
Change From Baseline in Modified Lund-MacKay (LMK) Computed Tomography (CT) Score at Week 24 Baseline and Week 24 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 Baseline up to Week 24 Change From Baseline to the 28-day Average of Daily Nasal Congestion Score (NCS) at Week 24 Baseline and Week 24 Change From Baseline to the 28-day Average of Daily Peak Nasal Inspiratory Flow (PNIF) at Week 24 Baseline and Week 24 Change From Baseline in Sino-Nasal Outcome Test (SNOT-22) Total Score at Week 24 Baseline and Week 24 Plasma Concentration of Brensocatib Pre-dose and at multiple timepoints post-dose up to Week 24
Trial Locations
- Locations (100)
USA004
🇺🇸Tulsa, Oklahoma, United States
ARG004
🇦🇷Rosario, Santa Fe, Argentina
ARG014
🇦🇷Mendoza, Argentina
ARG003
🇦🇷Mendoza, Argentina
ARG016
🇦🇷Rosario, Argentina
ARG008
🇦🇷Santa Fe, Argentina
BGR003
🇧🇬Plovdiv, Bulgaria
BGR006
🇧🇬Stara Zagora, Bulgaria
CAN007
🇨🇦Toronto, Ontario, Canada
CAN005
🇨🇦Montreal, Quebec, Canada
CAN001
🇨🇦Quebec City, Quebec, Canada
CAN002
🇨🇦Quebec, Canada
DNK002
🇩🇰Køge, Zeeland, Denmark
FRA002
🇫🇷Strasbourg, Bas-Rhin, France
ITA001
🇮🇹Rozzano, Lombardia, Italy
ITA002
🇮🇹Sassari, Sardegna, Italy
ITA003
🇮🇹Pisa, Toscana, Italy
POL009
🇵🇱Wroclaw, Dolnoslaskie, Poland
POL003
🇵🇱Lublin, Lubelskie, Poland
PRT004
🇵🇹Aveiro, Portugal
PRT002
🇵🇹Braga, Portugal
ESP003
🇪🇸Santander, Cantabria, Spain
USA009
🇺🇸Tampa, Florida, United States
USA015
🇺🇸Hershey, Pennsylvania, United States
USA031
🇺🇸Chicago, Illinois, United States
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
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
🇺🇸Saint Louis, Missouri, United States
USA033
🇺🇸New York, New York, United States
USA028
🇺🇸Tulsa, Oklahoma, 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
🇦🇷Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina
ARG012
🇦🇷Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina
ARG011
🇦🇷Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina
ARG017
🇦🇷Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina
ARG013
🇦🇷San Rafael, Mendoza, Argentina
ARG007
🇦🇷Rosario, Santa Fe, Argentina
ARG010
🇦🇷Rosario, Santa Fe, Argentina
ARG009
🇦🇷San Miguel De Tucumán, Tucumán, Argentina
ARG002
🇦🇷Mar del Plata, Argentina
AUS001
🇦🇺Herston, Queensland, Australia
AUS002
🇦🇺Spearwood, Western Australia, Australia
BEL001
🇧🇪Gent, Oost-Vlaanderen, Belgium
BEL002
🇧🇪Erpent, Belgium
BEL003
🇧🇪Sint-Lambrechts-Woluwe, Belgium
BGR005
🇧🇬Sofia, Sofia-Grad, Bulgaria
CAN003
🇨🇦Vancouver, British Columbia, Canada
CAN006
🇨🇦London, Ontario, 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
FRA003
🇫🇷Marseille, Bouches-du-Rhône, France
FRA001
🇫🇷Nantes, Loire-Atlantique, France
FRA004
🇫🇷La Roche-sur-Yon, Vendée, France
GER004
🇩🇪Wiesbaden, Hessen, Germany
GER009
🇩🇪Leipzig, Sachsen, Germany
GER003
🇩🇪Mittweida, Sachsen, Germany
GER008
🇩🇪Lübeck, Schleswig-Holstein, Germany
GER005
🇩🇪Jena, Thüringen, Germany
GER007
🇩🇪Berlin, Germany
GER001
🇩🇪Dresden, Germany
HUN003
🇭🇺Pécs, Baranya, Hungary
POL005
🇵🇱Kraków, Malopolskie, Poland
POL007
🇵🇱Wieliczka, Malopolskie, Poland
POL001
🇵🇱Warszawa, Mazowieckie, Poland
POL004
🇵🇱Białystok, Podlaskie, Poland
POL006
🇵🇱Katowice, Slaskie, Poland
POL002
🇵🇱Poznan, Wielkopolskie, Poland
POL010
🇵🇱Poznan, Wielkopolskie, Poland
POL008
🇵🇱Warszawa, Poland
PRT001
🇵🇹Guimarães, Braga, Portugal
PRT003
🇵🇹Lisbon, Lisboa, Portugal
PRT005
🇵🇹Senhora Da Hora, Porto, Portugal
ESP002
🇪🇸Jerez de la Frontera, Cádiz, Spain
ESP004
🇪🇸Malaga, Málaga, Spain
ESP001
🇪🇸Sevilla, Spain