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LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study)

Primary Purpose

Chronic Sinusitis, Chronic Rhinosinusitis (Diagnosis)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LYR-220 Design 1
LYR-220 Design 2
Bilateral sham procedure control
Sponsored by
Lyra Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Sinusitis

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of chronic rhinosinusitis.
  • Has had a prior bilateral total ethmoidectomy.
  • Has computed tomography (CT) ethmoid cavity opacification.
  • Has a Sinonasal Outcome Test (SNOT-22) ≥ 20 at Screening Visit.
  • Minimum cardinal symptom score.
  • Has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site or regulatory authority if applicable by national law.
  • Agrees to comply with all study requirements.

Exclusion Criteria:

  • Pregnant or breast feeding.
  • Known history of hypersensitivity or intolerance to corticosteroids.
  • History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, or atrophic rhinitis.
  • Known history of hypothalamic pituitary adrenal axial dysfunction.
  • Had dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
  • Past or present functional vision in only one eye.
  • Past, present, or planned organ transplant or chemotherapy with immunosuppression.
  • With prior cataract surgery or presence (in either eye) of posterior subcapsular cataract of grade 2 or higher, nuclear cataract of grade 3 or higher, or cortical cataract of grade 2 or higher or involving a minimum of center optic zone of 3 mm diameter.
  • Ethmoidectomy that was unilateral or partial.
  • Currently participating in an investigational drug or device study.

Sites / Locations

  • Lyra Investigational Site
  • Lyra Investigational Site
  • Lyra Investigational Site
  • Lyra Investigational Site
  • Lyra Investigational Site
  • Lyra Investigational Site
  • Lyra Investigational Site
  • Lyra Investigational Site
  • Lyra Investigational Site
  • Lyra Investigational Site
  • Lyra Investigational Site
  • Lyra Investigational Site
  • Lyra Investigational Site
  • Lyra Investigational Site
  • Lyra Investigational Site
  • Lyra Investigational Site
  • Lyra Investigational Site
  • Lyra Investigational Site
  • Lyra Investigational Site
  • Lyra Investigational Site
  • Lyra Investigational Site
  • Lyra Investigational Site
  • Lyra Investigational Site
  • Lyra Investigational Site
  • Lyra Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Treatment Arm A: LYR-220 Design 1

Treatment Arm B: LYR-220 Design 2

Treatment Arm C: Bilateral sham procedure control

Arm Description

Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1

Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2

Bilateral sham procedure control

Outcomes

Primary Outcome Measures

Product-related unexpected serious adverse events
Product-related unexpected serious adverse events
Plasma MF concentrations
Plasma MF concentrations

Secondary Outcome Measures

Adverse Events
Severity and percentage of subjects reporting treatment-emergent adverse events and serious adverse events
Laboratory Values (hematology and chemistry)
Percentage of subjects with abnormal and clinically significant abnormal laboratory values
Endoscopic findings
Percentage of subjects with newly identified or worsened endoscopic findings in the ethmoid cavity (mild, moderate, or severe)
Ophthalmic Assessment: Intraocular Pressure (IOP)
Percentage of subjects with clinically significant increase in IOP
Ophthalmic Assessment: Cataract
Percentage of subjects with newly identified or worsened cataract in one or both eyes
Improving Chronic Rhinosinusitis (CRS) specific Quality of Life as per the 22-item sino-nasal outcome test (SNOT-22) questionnaire
Change from baseline in total patient-reported outcome measures. Each symptom is scored as it has been over the past two weeks on a 6-point scale (0 to 5: 0 = no problem to 5 = problem as bad as it can be). Higher scores indicate severity of symptoms.
Change in Chronic Rhinosinusitis (CRS) symptom scores
Change from baseline in the average composite score

Full Information

First Posted
August 27, 2021
Last Updated
September 18, 2023
Sponsor
Lyra Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05035654
Brief Title
LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study)
Official Title
BEACON: A Phase II, Patient-blinded, Two-part, Randomized, Parallel-group Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of LYR-220 in Chronic Rhinosinusitis (CRS) Patients Who Have Had a Prior Ethmoidectomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 23, 2021 (Actual)
Primary Completion Date
August 30, 2023 (Actual)
Study Completion Date
August 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lyra Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will assess the safety, tolerability, pharmacokinetics and efficacy of two LYR-220 designs in symptomatic adult chronic rhinosinusitis (CRS) subjects who have had a prior functional endoscopic sinus surgery.
Detailed Description
This is a Phase II, Patient-blinded, Two-part, Randomized, Parallel-group Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of LYR-220. The study will consist of two parts: Part 1 will enroll up to 10 patients and is open label. Part 2 is randomized, sham controlled and will enroll approximately 40 patients. The study follow-up duration is 28 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis, Chronic Rhinosinusitis (Diagnosis)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm A: LYR-220 Design 1
Arm Type
Experimental
Arm Description
Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1
Arm Title
Treatment Arm B: LYR-220 Design 2
Arm Type
Experimental
Arm Description
Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2
Arm Title
Treatment Arm C: Bilateral sham procedure control
Arm Type
Sham Comparator
Arm Description
Bilateral sham procedure control
Intervention Type
Drug
Intervention Name(s)
LYR-220 Design 1
Intervention Description
LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1
Intervention Type
Drug
Intervention Name(s)
LYR-220 Design 2
Intervention Description
LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2
Intervention Type
Drug
Intervention Name(s)
Bilateral sham procedure control
Intervention Description
Bilateral sham procedure control
Primary Outcome Measure Information:
Title
Product-related unexpected serious adverse events
Description
Product-related unexpected serious adverse events
Time Frame
Through Week 28
Title
Plasma MF concentrations
Description
Plasma MF concentrations
Time Frame
Through Week 25
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Severity and percentage of subjects reporting treatment-emergent adverse events and serious adverse events
Time Frame
Through Week 28
Title
Laboratory Values (hematology and chemistry)
Description
Percentage of subjects with abnormal and clinically significant abnormal laboratory values
Time Frame
Through Week 25
Title
Endoscopic findings
Description
Percentage of subjects with newly identified or worsened endoscopic findings in the ethmoid cavity (mild, moderate, or severe)
Time Frame
Through Week 25
Title
Ophthalmic Assessment: Intraocular Pressure (IOP)
Description
Percentage of subjects with clinically significant increase in IOP
Time Frame
Through Week 25
Title
Ophthalmic Assessment: Cataract
Description
Percentage of subjects with newly identified or worsened cataract in one or both eyes
Time Frame
Through Week 25
Title
Improving Chronic Rhinosinusitis (CRS) specific Quality of Life as per the 22-item sino-nasal outcome test (SNOT-22) questionnaire
Description
Change from baseline in total patient-reported outcome measures. Each symptom is scored as it has been over the past two weeks on a 6-point scale (0 to 5: 0 = no problem to 5 = problem as bad as it can be). Higher scores indicate severity of symptoms.
Time Frame
Through Week 28
Title
Change in Chronic Rhinosinusitis (CRS) symptom scores
Description
Change from baseline in the average composite score
Time Frame
Through Week 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of chronic rhinosinusitis. Has had a prior bilateral total ethmoidectomy. Has computed tomography (CT) ethmoid cavity opacification. Has a Sinonasal Outcome Test (SNOT-22) ≥ 20 at Screening Visit. Minimum cardinal symptom score. Has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site or regulatory authority if applicable by national law. Agrees to comply with all study requirements. Exclusion Criteria: Pregnant or breast feeding. Known history of hypersensitivity or intolerance to corticosteroids. History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, or atrophic rhinitis. Known history of hypothalamic pituitary adrenal axial dysfunction. Had dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit. Past or present functional vision in only one eye. Past, present, or planned organ transplant or chemotherapy with immunosuppression. With prior cataract surgery or presence (in either eye) of posterior subcapsular cataract of grade 2 or higher, nuclear cataract of grade 3 or higher, or cortical cataract of grade 2 or higher or involving a minimum of center optic zone of 3 mm diameter. Ethmoidectomy that was unilateral or partial. Currently participating in an investigational drug or device study.
Facility Information:
Facility Name
Lyra Investigational Site
City
Carlsbad
State/Province
California
ZIP/Postal Code
92008
Country
United States
Facility Name
Lyra Investigational Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Lyra Investigational Site
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Lyra Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90501
Country
United States
Facility Name
Lyra Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Facility Name
Lyra Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Lyra Investigational Site
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Lyra Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40205
Country
United States
Facility Name
Lyra Investigational Site
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Lyra Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Lyra Investigational Site
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Lyra Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Lyra Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Lyra Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Lyra Investigational Site
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Lyra Investigational Site
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Lyra Investigational Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Lyra Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76109
Country
United States
Facility Name
Lyra Investigational Site
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Facility Name
Lyra Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Lyra Investigational Site
City
South Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Lyra Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99201
Country
United States
Facility Name
Lyra Investigational Site
City
Bedford Park
ZIP/Postal Code
5042
Country
Australia
Facility Name
Lyra Investigational Site
City
Brisbane
Country
Australia
Facility Name
Lyra Investigational Site
City
Melbourne
Country
Australia

12. IPD Sharing Statement

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LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study)

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