Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

COMPLETED

NCT06013241

PHASE2

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

Sponsor: Insmed Incorporated

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

288

Start Date

2023-10-30

Completion Date

2025-10-30

Last Updated

2026-09-30

Healthy Volunteers

Conditions

Chronic Rhinosinusitis Without Nasal Polyps

Interventions

DRUG

Brensocatib

Film-coated tablet.

DRUG

Placebo

Film-coated tablet.

DRUG

Mometasone furoate nasal spray (MFNS)

Nasal spray suspension.

Inclusion Criteria: * 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: 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: * 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.

Locations (100)

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, Olomouc Region, Czechia

CZE003

Pardubice, Pardubice Region, 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, Region Sjælland, 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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (100)