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New pill aims to ease stuffy nose and facial pain for sinusitis sufferers

NCT ID NCT06013241

Symptom relief Sponsor: Insmed Incorporated Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called brensocatib in 288 adults with long-term sinus inflammation but no nasal polyps. Participants took either 10 mg, 40 mg, or a placebo daily for 24 weeks. The goal was to see if the drug could improve daily symptoms like congestion, runny nose, and facial pain better than a placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

288 people

The number who actually took part.

Started

Oct 2023

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

chronic rhinosinusitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic rhinosinusitis without nasal polyps

Contacts and locations

Locations

  • ARG001

    La Plata, Buenos Aires, B1900, Argentina

  • ARG002

    Mar del Plata, B7602DCK, Argentina

  • ARG003

    Mendoza, M5500CCG, Argentina

  • ARG004

    Rosario, Santa Fe Province, S2013, Argentina

  • ARG005

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1121ABE, Argentina

  • ARG006

    Lobos, Buenos Aires, B7240AAN, Argentina

  • ARG007

    Rosario, Santa Fe Province, S2013DBS, Argentina

  • ARG008

    Santa Fe, 3000, Argentina

  • ARG009

    San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

  • ARG010

    Rosario, Santa Fe Province, S2013DTC, Argentina

  • ARG011

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1425, Argentina

  • ARG012

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1414, Argentina

  • ARG013

    San Rafael, Mendoza Province, M5600IBJ, Argentina

  • ARG014

    Mendoza, 5500, Argentina

  • ARG015

    La Plata, Buenos Aires, B1900BNN, Argentina

  • ARG016

    Rosario, S2002KDT, Argentina

  • ARG017

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1426ABP, Argentina

  • AUS001

    Herston, Queensland, 4029, Australia

  • AUS002

    Spearwood, Western Australia, 6163, Australia

  • BEL001

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • BEL002

    Erpent, 5101, Belgium

  • BEL003

    Woluwe-Saint-Lambert, 1200, Belgium

  • BGR003

    Plovdiv, 4001, Bulgaria

  • BGR005

    Sofia, Sofia-Grad, 1606, Bulgaria

  • BGR006

    Stara Zagora, 6000, Bulgaria

  • CAN001

    Québec, Quebec, G1S 4L8, Canada

  • CAN002

    Québec, G1V 4W2, Canada

  • CAN003

    Vancouver, British Columbia, V6Z 1Y6, Canada

  • CAN005

    Montreal, Quebec, H4A 3J1, Canada

  • CAN006

    London, Ontario, N6A 4V2, Canada

  • CAN007

    Toronto, Ontario, M5G 1X5, Canada

  • CZE002

    Olomouc, Olomouc Region, 779 00, Czechia

  • CZE003

    Pardubice, Pardubice Region, 532 03, Czechia

  • CZE004

    Prague, 140 59, Czechia

  • CZE005

    Nový Hradec Králové, 500 05, Czechia

  • DNK001

    København Ø, Capital, 2100, Denmark

  • DNK002

    Køge, Region Sjælland, 4600, Denmark

  • DNK003

    Aarhus C, Central Jutland, 8000, Denmark

  • DNK004

    Hillerød, Capital, 3400, Denmark

  • ESP001

    Seville, 41009, Spain

  • ESP002

    Jerez de la Frontera, Cádiz, 11407, Spain

  • ESP003

    Santander, Cantabria, 39008, Spain

  • ESP004

    Málaga, Málaga, 29009, Spain

  • FRA001

    Nantes, Loire-Atlantique, 44000, France

  • FRA002

    Strasbourg, Bas-Rhin, 67200, France

  • FRA003

    Marseille, Bouches-du-Rhône, 13010, France

  • FRA004

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

  • GER001

    Dresden, 01307, Germany

  • GER003

    Mittweida, Saxony, 09648, Germany

  • GER004

    Wiesbaden, Hesse, 65183, Germany

  • GER005

    Jena, Thuringia, 07747, Germany

  • GER007

    Berlin, 10117, Germany

  • GER008

    Lübeck, Schleswig-Holstein, 23562, Germany

  • GER009

    Leipzig, Saxony, 04103, Germany

  • HUN003

    Pécs, Baranya, 7621, Hungary

  • ITA001

    Rozzano, Lombardy, 20089, Italy

  • ITA002

    Sassari, Sardinia, 07100, Italy

  • ITA003

    Pisa, Tuscany, 56124, Italy

  • POL001

    Warsaw, Masovian Voivodeship, 00-189, Poland

  • POL002

    Poznan, Greater Poland Voivodeship, 60-309, Poland

  • POL003

    Lublin, Lublin Voivodeship, 20-954, Poland

  • POL004

    Bialystok, Podlaskie Voivodeship, 15-276, Poland

  • POL005

    Krakow, Lesser Poland Voivodeship, 30-033, Poland

  • POL006

    Katowice, Silesian Voivodeship, 40-611, Poland

  • POL007

    Wieliczka, Lesser Poland Voivodeship, 32-020, Poland

  • POL008

    Warsaw, 04-141, Poland

  • POL009

    Wroclaw, Lower Silesian Voivodeship, 52-416, Poland

  • POL010

    Poznan, Greater Poland Voivodeship, 60-693, Poland

  • PRT001

    Guimarães, Braga District, 4835-044, Portugal

  • PRT002

    Braga, 4710, Portugal

  • PRT003

    Lisbon, Lisbon District, 1349-019, Portugal

  • PRT004

    Aveiro, 3814-501, Portugal

  • PRT005

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

  • USA001

    Miami, Florida, 33135, United States

  • USA002

    Roseville, California, 95661, United States

  • USA003

    New Albany, Indiana, 47150, United States

  • USA004

    Tulsa, Oklahoma, 74136, United States

  • USA005

    Norfolk, Virginia, 23507, United States

  • USA006

    Upland, California, 91786, United States

  • USA009

    Tampa, Florida, 33613, United States

  • USA011

    Columbia, Missouri, 65212, United States

  • USA015

    Hershey, Pennsylvania, 17033, United States

  • USA016

    Boca Raton, Florida, 33487, United States

  • USA018

    Houston, Texas, 77030, United States

  • USA019

    Hollywood, Florida, 33024, United States

  • USA021

    Chicago, Illinois, 60612, United States

  • USA022

    North Charleston, South Carolina, 29406, United States

  • USA023

    Charleston, South Carolina, 29425, United States

  • USA024

    St Louis, Missouri, 63141, United States

  • USA025

    Dallas, Texas, 75231, United States

  • USA026

    Baltimore, Maryland, 21287, United States

  • USA028

    Tulsa, Oklahoma, 74132, United States

  • USA029

    Houston, Texas, 77022, United States

  • USA030

    San Antonio, Texas, 78258, United States

  • USA031

    Chicago, Illinois, 60611, United States

  • USA033

    New York, New York, 10016, United States

  • USA034

    Tucson, Arizona, 85704, United States

  • USA035

    Mandeville, Louisiana, 70471, United States

  • USA037

    Fredericksburg, Texas, 78624, United States

  • USA038

    Tomball, Texas, 77375, United States

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