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

NCT06013241
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Phase
Phase 2
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Recruitment status
Completed
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Participants
288
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Lead sponsor
Insmed Incorporated
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Start date
2023-10-30
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Number of sites
100
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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.
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Acronym
BiRCh
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Short title
A Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
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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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2025-10-30
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First posted
2023-08-28
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Registry last updated
2025-11-10
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Primary completion date
2025-09-30
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Start date
2023-10-30
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Actual participants
288
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Participants
288
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
100
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Insmed Incorporated
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06013241
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ClinicalTrials.gov ID
NCT06013241
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

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

    Timeframe: Baseline and Week 24

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

    Timeframe: 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

    Timeframe: 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

    Timeframe: Baseline up to Week 24

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

    Timeframe: Baseline and Week 24

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

    Timeframe: Baseline and Week 24

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

    Timeframe: Baseline and Week 24

  7. Plasma Concentration of Brensocatib

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

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

    Timeframe: Up to 28 weeks

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

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  • 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).

  • 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.

Sources for eligibility
clinicaltrials.gov

  • USA034Tucson, United States
  • USA002Roseville, United States
  • USA006Upland, United States
  • USA016Boca Raton, United States
  • USA019Hollywood, United States
  • USA001Miami, United States
  • USA009Tampa, United States
  • USA031Chicago, United States
  • USA021Chicago, United States
  • USA003New Albany, United States
  • USA035Mandeville, United States
  • USA026Baltimore, United States
  • USA011Columbia, United States
  • USA024St Louis, United States
  • USA033New York, United States
  • USA028Tulsa, United States
  • USA004Tulsa, United States
  • USA015Hershey, United States
  • USA023Charleston, United States
  • USA022North Charleston, United States
  • USA025Dallas, United States
  • USA037Fredericksburg, United States
  • USA029Houston, United States
  • USA018Houston, United States
  • USA030San Antonio, United States

And 75 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2022-502481-24-00
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Targets (2)