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Completed

NCT Number: NCT06013241

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ARG001, La Plata, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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).

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.

Treatment and study plan

Brensocatib

Drug

Film-coated tablet.

Other names: INS1007

Placebo

Drug

Film-coated tablet.

Mometasone Furoate Nasal Spray (MFNS)

Drug

Nasal spray suspension.

Primary outcomes

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

    Time frame: Baseline and Week 24

Secondary outcomes

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

    Time frame: 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.

  2. Change From Baseline in Modified Lund-MacKay (LMK) Computed Tomography (CT) Score at Week 24

    Time frame: Baseline and Week 24

  3. 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

    Time frame: Baseline up to Week 24

  4. Change From Baseline to the 28-day Average of Daily Nasal Congestion Score (NCS) at Week 24

    Time frame: Baseline and Week 24

  5. Change From Baseline to the 28-day Average of Daily Peak Nasal Inspiratory Flow (PNIF) at Week 24

    Time frame: Baseline and Week 24

  6. Change From Baseline in Sino-Nasal Outcome Test (SNOT-22) Total Score at Week 24

    Time frame: Baseline and Week 24

  7. Plasma Concentration of Brensocatib

    Time frame: Pre-dose and at multiple timepoints post-dose up to Week 24

  8. Percentage of Participants who Experienced at Least One Adverse Event (AE)

    Time frame: Up to 28 weeks

    Determination of the safety and tolerability of brensocatib compared with placebo.

Sponsors and collaborators

Lead sponsor

Insmed Incorporated

Industry

Registry information

Official study 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

Acronym: BiRCh

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 28, 2023
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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