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

NCT06013241 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: INS1007-2212022-502481-24-00
• Study Type: interventional
• Target: 288
• Locations: 15 countries
• Sites: 100

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.

Conditions

Chronic Rhinosinusitis Without Nasal Polyps

Keywords

CRSsNP

Outcome Measures

Primary Outcomes (1)

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

  Baseline and Week 24

Secondary Outcomes (8)

• Change From Baseline in Percentage of Sinus (Maxillary and Ethmoid) Opacification as Measured by Volumetry at Week 24

  Baseline and Week 24

• 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

Study Arms (3)

Brensocatib 40 mg

EXPERIMENTAL

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; Drug: Mometasone furoate nasal spray (MFNS)

Brensocatib 10 mg

EXPERIMENTAL

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; Drug: Mometasone furoate nasal spray (MFNS)

Placebo

PLACEBO COMPARATOR

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: Placebo; Drug: Mometasone furoate nasal spray (MFNS)

Interventions

Brensocatib DRUG

Film-coated tablet.

Also known as: INS1007

Brensocatib 10 mg; Brensocatib 40 mg

Placebo DRUG

Film-coated tablet.

Placebo

Mometasone furoate nasal spray (MFNS) DRUG

Nasal spray suspension.

Brensocatib 10 mg; Brensocatib 40 mg; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insmed Incorporated: lead

Study Sites (100)

USA034

Tucson, Arizona, 85704, United States

Location

USA002

Roseville, California, 95661, United States

Location

USA006

Upland, California, 91786, United States

Location

USA016

Boca Raton, Florida, 33487, United States

Location

USA019

Hollywood, Florida, 33024, United States

Location

USA001

Miami, Florida, 33135, United States

Location

USA009

Tampa, Florida, 33613, United States

Location

USA031

Chicago, Illinois, 60611, United States

Location

USA021

Chicago, Illinois, 60612, United States

Location

USA003

New Albany, Indiana, 47150, United States

Location

USA035

Mandeville, Louisiana, 70471, United States

Location

USA026

Baltimore, Maryland, 21287, United States

Location

USA011

Columbia, Missouri, 65212, United States

Location

USA024

St Louis, Missouri, 63141, United States

Location

USA033

New York, New York, 10016, United States

Location

USA028

Tulsa, Oklahoma, 74132, United States

Location

USA004

Tulsa, Oklahoma, 74136, United States

Location

USA015

Hershey, Pennsylvania, 17033, United States

Location

USA023

Charleston, South Carolina, 29425, United States

Location

USA022

North Charleston, South Carolina, 29406, United States

Location

USA025

Dallas, Texas, 75231, United States

Location

USA037

Fredericksburg, Texas, 78624, United States

Location

USA029

Houston, Texas, 77022, United States

Location

USA018

Houston, Texas, 77030, United States

Location

USA030

San Antonio, Texas, 78258, United States

Location

USA038

Tomball, Texas, 77375, United States

Location

USA005

Norfolk, Virginia, 23507, United States

Location

ARG015

La Plata, Buenos Aires, B1900BNN, Argentina

Location

ARG001

La Plata, Buenos Aires, B1900, Argentina

Location

ARG006

Lobos, Buenos Aires, B7240AAN, Argentina

Location

ARG005

Buenos Aires, Ciudad Autónoma de BuenosAires, C1121ABE, Argentina

Location

ARG012

Buenos Aires, Ciudad Autónoma de BuenosAires, C1414, Argentina

Location

ARG011

Buenos Aires, Ciudad Autónoma de BuenosAires, C1425, Argentina

Location

ARG017

Buenos Aires, Ciudad Autónoma de BuenosAires, C1426ABP, Argentina

Location

ARG013

San Rafael, Mendoza Province, M5600IBJ, Argentina

Location

ARG007

Rosario, Santa Fe Province, S2013DBS, Argentina

Location

ARG010

Rosario, Santa Fe Province, S2013DTC, Argentina

Location

ARG004

Rosario, Santa Fe Province, S2013, Argentina

Location

ARG009

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

Location

ARG002

Mar del Plata, B7602DCK, Argentina

Location

ARG014

Mendoza, 5500, Argentina

Location

ARG003

Mendoza, M5500CCG, Argentina

Location

ARG016

Rosario, S2002KDT, Argentina

Location

ARG008

Santa Fe, 3000, Argentina

Location

AUS001

Herston, Queensland, 4029, Australia

Location

AUS002

Spearwood, Western Australia, 6163, Australia

Location

BEL001

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

BEL002

Erpent, 5101, Belgium

Location

BEL003

Woluwe-Saint-Lambert, 1200, Belgium

Location

BGR005

Sofia, Sofia-Grad, 1606, Bulgaria

Location

BGR003

Plovdiv, 4001, Bulgaria

Location

BGR006

Stara Zagora, 6000, Bulgaria

Location

CAN003

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

CAN006

London, Ontario, N6A 4V2, Canada

Location

CAN007

Toronto, Ontario, M5G 1X5, Canada

Location

CAN005

Montreal, Quebec, H4A 3J1, Canada

Location

CAN001

Québec, Quebec, G1S 4L8, Canada

Location

CAN002

Québec, G1V 4W2, Canada

Location

CZE002

Olomouc, Olomoucký kraj, 779 00, Czechia

Location

CZE003

Pardubice, Pardubický kraj, 532 03, Czechia

Location

CZE005

Nový Hradec Králové, 500 05, Czechia

Location

CZE004

Prague, 140 59, Czechia

Location

DNK004

Hillerød, Capital, 3400, Denmark

Location

DNK001

København Ø, Capital, 2100, Denmark

Location

DNK003

Aarhus C, Central Jutland, 8000, Denmark

Location

DNK002

Køge, Zeeland, 4600, Denmark

Location

FRA002

Strasbourg, Bas-Rhin, 67200, France

Location

FRA003

Marseille, Bouches-du-Rhône, 13010, France

Location

FRA001

Nantes, Loire-Atlantique, 44000, France

Location

FRA004

La Roche-sur-Yon, Vendée, 85925, France

Location

GER004

Wiesbaden, Hesse, 65183, Germany

Location

GER009

Leipzig, Saxony, 04103, Germany

Location

GER003

Mittweida, Saxony, 09648, Germany

Location

GER008

Lübeck, Schleswig-Holstein, 23562, Germany

Location

GER005

Jena, Thuringia, 07747, Germany

Location

GER007

Berlin, 10117, Germany

Location

GER001

Dresden, 01307, Germany

Location

HUN003

Pécs, Baranya, 7621, Hungary

Location

ITA001

Rozzano, Lombardy, 20089, Italy

Location

ITA002

Sassari, Sardinia, 07100, Italy

Location

ITA003

Pisa, Tuscany, 56124, Italy

Location

POL002

Poznan, Greater Poland Voivodeship, 60-309, Poland

Location

POL010

Poznan, Greater Poland Voivodeship, 60-693, Poland

Location

POL005

Krakow, Lesser Poland Voivodeship, 30-033, Poland

Location

POL007

Wieliczka, Lesser Poland Voivodeship, 32-020, Poland

Location

POL009

Wroclaw, Lower Silesian Voivodeship, 52-416, Poland

Location

POL003

Lublin, Lublin Voivodeship, 20-954, Poland

Location

POL001

Warsaw, Masovian Voivodeship, 00-189, Poland

Location

POL004

Bialystok, Podlaskie Voivodeship, 15-276, Poland

Location

POL006

Katowice, Silesian Voivodeship, 40-611, Poland

Location

POL008

Warsaw, 04-141, Poland

Location

PRT001

Guimarães, Braga District, 4835-044, Portugal

Location

PRT003

Lisbon, Lisbon District, 1349-019, Portugal

Location

PRT005

Senhora da Hora, Porto District, 4464-513, Portugal

Location

PRT004

Aveiro, 3814-501, Portugal

Location

PRT002

Braga, 4710, Portugal

Location

ESP003

Santander, Cantabria, 39008, Spain

Location

ESP002

Jerez de la Frontera, Cádiz, 11407, Spain

Location

ESP004

Málaga, Málaga, 29009, Spain

Location

ESP001

Seville, 41009, Spain

Location

Related Links

• Prescreening tool

MeSH Terms

Interventions

brensocatib

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 28, 2023
• Study Start: October 30, 2023
• Primary Completion: September 30, 2025
• Study Completion: October 30, 2025
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (7); DK (4); IT (3); BU (3); CZ (4); FR (4); AU (2); HU (1); PL (10); BE (3); US (27); ES (4); AR (17); CA (6); PT (5)