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

Primary Purpose

Chronic Rhinosinusitis Without Nasal Polyps

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Brensocatib
Placebo
Mometasone furoate nasal spray (MFNS)
Sponsored by
Insmed Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Rhinosinusitis Without Nasal Polyps focused on measuring CRSsNP

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 (weekly average score). 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 of 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.

Sites / Locations

  • USA010
  • USA019
  • USA001Recruiting
  • USA003

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Brensocatib 40 mg

Brensocatib 10 mg

Placebo

Arm Description

Participants will receive brensocatib 40 mg tablet, orally, QD for 24 weeks along with mometasone furoate nasal spray (MFNS) by nasal route as background therapy at a stable dose according to the Investigator's discretion and local guidance.

Participants will receive brensocatib 10 mg tablet, orally, QD for 24 weeks along with MFNS by nasal route as background therapy at a stable dose according to the Investigator's discretion and local guidance.

Participants will receive a brensocatib-matching placebo tablet, orally, QD for 24 weeks along with MFNS by nasal route as background therapy at a stable dose according to the Investigator's discretion and local guidance.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change From Baseline in Percentage of Sinus (Maxillary and Ethmoid) Opacification as Measured by Volumetry at 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.
Change From Baseline in Modified Lund-MacKay (LMK) Computed Tomography (CT) Score at Week 24
Participant Status Indicator Assessed as Percentage of Participants Requiring Rescue (Antibiotics, Systemic Corticosteroids [SCS], and/or Nasal Surgery) due to Worsening of any Chronic Rhinosinusitis (CRS) Symptoms
Change From Baseline to the 28-day Average of Daily Nasal Congestion Score (NCS) at Week 24
Change From Baseline to the 28-day Average of Daily Peak Nasal Inspiratory Flow (PNIF) at Week 24
Change From Baseline in Sino-Nasal Outcome Test (SNOT-22) Total Score at Week 24
Plasma Concentration of Brensocatib
Percentage of Participants who Experienced at Least One Adverse Event (AE)
Determination of the safety and tolerability of brensocatib compared with placebo.

Full Information

First Posted
August 22, 2023
Last Updated
October 13, 2023
Sponsor
Insmed Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT06013241
Brief Title
A Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
Acronym
BiRCh
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2023 (Anticipated)
Primary Completion Date
August 29, 2025 (Anticipated)
Study Completion Date
September 25, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insmed Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis Without Nasal Polyps
Keywords
CRSsNP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brensocatib 40 mg
Arm Type
Experimental
Arm Description
Participants will receive brensocatib 40 mg tablet, orally, QD for 24 weeks along with mometasone furoate nasal spray (MFNS) by nasal route as background therapy at a stable dose according to the Investigator's discretion and local guidance.
Arm Title
Brensocatib 10 mg
Arm Type
Experimental
Arm Description
Participants will receive brensocatib 10 mg tablet, orally, QD for 24 weeks along with MFNS by nasal route as background therapy at a stable dose according to the Investigator's discretion and local guidance.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive a brensocatib-matching placebo tablet, orally, QD for 24 weeks along with MFNS by nasal route as background therapy at a stable dose according to the Investigator's discretion and local guidance.
Intervention Type
Drug
Intervention Name(s)
Brensocatib
Other Intervention Name(s)
INS1007
Intervention Description
Film-coated tablet.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Film-coated tablet.
Intervention Type
Drug
Intervention Name(s)
Mometasone furoate nasal spray (MFNS)
Intervention Description
Nasal spray suspension.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Change From Baseline in Percentage of Sinus (Maxillary and Ethmoid) Opacification as Measured by Volumetry at Week 24
Description
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.
Time Frame
Baseline and Week 24
Title
Change From Baseline in Modified Lund-MacKay (LMK) Computed Tomography (CT) Score at Week 24
Time Frame
Baseline and Week 24
Title
Participant Status Indicator Assessed as Percentage of Participants Requiring Rescue (Antibiotics, Systemic Corticosteroids [SCS], and/or Nasal Surgery) due to Worsening of any Chronic Rhinosinusitis (CRS) Symptoms
Time Frame
Baseline to Week 24
Title
Change From Baseline to the 28-day Average of Daily Nasal Congestion Score (NCS) at Week 24
Time Frame
Baseline and Week 24
Title
Change From Baseline to the 28-day Average of Daily Peak Nasal Inspiratory Flow (PNIF) at Week 24
Time Frame
Baseline and Week 24
Title
Change From Baseline in Sino-Nasal Outcome Test (SNOT-22) Total Score at Week 24
Time Frame
Baseline and Week 24
Title
Plasma Concentration of Brensocatib
Time Frame
Pre-dose and at multiple timepoints post-dose up to Week 24
Title
Percentage of Participants who Experienced at Least One Adverse Event (AE)
Description
Determination of the safety and tolerability of brensocatib compared with placebo.
Time Frame
Up to 28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 (weekly average score). 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 of 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Insmed Medical Information
Phone
1-844-446-7633
Email
medicalinformation@insmed.com
Facility Information:
Facility Name
USA010
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909-1177
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
USA019
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024-2514
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
USA001
City
Miami
State/Province
Florida
ZIP/Postal Code
33135-2967
Country
United States
Individual Site Status
Recruiting
Facility Name
USA003
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150-4537
Country
United States
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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