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

Last updated: March 10, 2025
Sponsor: Insmed Incorporated
Overall Status: Active - Recruiting

Phase

2

Condition

Soft Tissue Infections

Sinusitis

Sinus Infections

Treatment

Mometasone furoate nasal spray (MFNS)

Placebo

Brensocatib

Clinical Study ID

NCT06013241
INS1007-221
2022-502481-24-00
  • Ages 18-75
  • All Genders

Study 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.

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 (weeklyaverage score).

  • 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:

  1. Previous sinonasal surgery for CRS, including but not limited to fenestratedendoscopic sinus surgery and balloon sinuplasty.

  2. 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.

  3. 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/exclusioncriteria may apply.

Study Design

Total Participants: 270
Treatment Group(s): 3
Primary Treatment: Mometasone furoate nasal spray (MFNS)
Phase: 2
Study Start date:
October 30, 2023
Estimated Completion Date:
September 25, 2025

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  • ARG001

    La Plata, Buenos Aires B1900
    Argentina

    Active - Recruiting

  • ARG015

    La Plata, Buenos Aires B1900BNN
    Argentina

    Active - Recruiting

  • ARG006

    Lobos, Buenos Aires B7240AAN
    Argentina

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  • ARG005

    Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires C1121ABE
    Argentina

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  • ARG011

    Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires C1425
    Argentina

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    Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires C1414
    Argentina

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  • ARG017

    Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires C1426ABP
    Argentina

    Site Not Available

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    San Rafael, Mendoza M5600IBJ
    Argentina

    Active - Recruiting

  • ARG004

    Rosario, Santa Fe S2013
    Argentina

    Active - Recruiting

  • ARG007

    Rosario, Santa Fe S2013DBS
    Argentina

    Active - Recruiting

  • ARG010

    Rosario, Santa Fe S2013DTC
    Argentina

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  • ARG009

    San Miguel De Tucumán, Tucumán T4000AXL
    Argentina

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    Mar del Plata, B7602DCK
    Argentina

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    Mendoza, M5500CCG
    Argentina

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    Mendoza, 5500
    Argentina

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    Rosario, S2002KDT
    Argentina

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    Santa Fe, 3000
    Argentina

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    Birtinya, Queensland 4575
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    Herston, Queensland 4029
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    Melbourne, Victoria 3000
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    Spearwood, Western Australia 6163
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    Faulx-les-Tombes, Namur 5340
    Belgium

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    Faux-Les-Tombes, Namur 5340
    Belgium

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    Gent, Oost-Vlaanderen 9000
    Belgium

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    Erpent, 5101
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    Sint-Lambrechts-Woluwe, 1200
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    Woluwe-Saint-Lambert, 1200
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    Sofia, Sofia-Grad 1527
    Bulgaria

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    Sofia, Sofia-Grad 1606
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    Plovdiv, 4001
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    Stara Zagora, 6003
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    Stara Zagora, 6000
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    Vancouver, British Columbia V6Z 1Y6
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    London, Ontario N6A 4V2
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    Olomouc, Olomoucký Kraj 779 00
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    Prague, 140 59
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    København Ø, Capital 2100
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    Aarhus C, Central Jutland 8000
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    Køge, Zeeland 4600
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    Mittweida, Sachsen 09648
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    Dresden, 01307
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    Pécs, Baranya 7621
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    Sassari, Sardegna 07100
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    Pisa, Toscana 56124
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    Siena, Toscana 53100
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    Jerez de la Frontera, Cádiz 11407
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    Sevilla, 41009
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    Tulsa, Oklahoma 74132
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    Tomball, Texas 77375
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    Norfolk, Virginia 23507
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