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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Sinusitis; Chronic Rhinosinusitis (Diagnosis)
• Intervention / Treatment: Drug: LYR-220 Design 1 (Part 1 only); Drug: LYR-220 Design 2 (Part 1 and Part 2); Drug: Bilateral sham procedure control (Part 2)

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Bedford Park, Australia, 5042
    • Lyra Investigational Site
  • Brisbane, Australia
    • Lyra Investigational Site
  • Melbourne, Australia
    • Lyra Investigational Site
• United States
  • California
    • Carlsbad, California, United States, 92008
      • Lyra Investigational Site
    • La Mesa, California, United States, 91942
      • Lyra Investigational Site
    • Roseville, California, United States, 95661
      • Lyra Investigational Site
    • Torrance, California, United States, 90501
      • Lyra Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60208
      • Lyra Investigational Site
    • Chicago, Illinois, United States, 60657
      • Lyra Investigational Site
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Lyra Investigational Site
  • Kentucky
    • Louisville, Kentucky, United States, 40205
      • Lyra Investigational Site
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Lyra Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Lyra Investigational Site
  • New York
    • New Hyde Park, New York, United States, 11042
      • Lyra Investigational Site
    • New York, New York, United States, 10016
      • Lyra Investigational Site
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Lyra Investigational Site
    • Winston-Salem, North Carolina, United States, 27103
      • Lyra Investigational Site
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
      • Lyra Investigational Site
  • South Carolina
    • Orangeburg, South Carolina, United States, 29118
      • Lyra Investigational Site
    • Spartanburg, South Carolina, United States, 29303
      • Lyra Investigational Site
  • Texas
    • Fort Worth, Texas, United States, 76109
      • Lyra Investigational Site
    • McKinney, Texas, United States, 75069
      • Lyra Investigational Site
    • San Antonio, Texas, United States, 78258
      • Lyra Investigational Site
  • Utah
    • South Ogden, Utah, United States, 84405
      • Lyra Investigational Site
  • Washington
    • Spokane, Washington, United States, 99201
      • Lyra Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Treatment Arm LYR-220 Design 1; Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1	Drug: LYR-220 Design 1 (Part 1 only); LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1
Experimental: Part 1 and Part 2: Treatment Arm LYR-220 Design 2; Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2	Drug: LYR-220 Design 2 (Part 1 and Part 2); LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2
Sham Comparator: Part 2: Treatment Arm Bilateral sham procedure control; Bilateral sham procedure control	Drug: Bilateral sham procedure control (Part 2); Bilateral sham procedure control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Product-related Unexpected Serious Adverse Events	Product-related unexpected serious adverse events	Through Week 28
Plasma MF Concentrations	Plasma MF concentrations at 1 hour post study treatment administration and at Days 2 or 3, days 5 or 8, and Weeks 4,12,16 or 20, 24 and 25. The PK analysis will be performed based on subjects with available plasma MF concentration data post Day 1 administration procedure.	Through Week 25

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ophthalmic Assessment: Intraocular Pressure (IOP)	Percentage of subjects with clinically significant increase in IOP	Through Week 25
Ophthalmic Assessment: Cataract	Percentage of subjects with newly identified or worsened cataract in one or both eyes	Through Week 25
Adverse Events	Percentage of subjects reporting treatment-emergent adverse events	Through Week 28
Endoscopic Findings	Percentage of subjects with newly identified or worsened endoscopic findings in the ethmoid cavity (mild, moderate, or severe)	Through Week 25
Improving Chronic Rhinosinusitis (CRS) Specific Quality of Life as Per the 22-item Sino-nasal Outcome Test (SNOT-22) Questionnaire	The 22-item Sino-Nasal Outcome Test (SNOT-22) questionnaire is a 22-item disease-specific quality of life instrument validated for use in CRS. Each symptom is scored as it has been over the past 2 weeks on a 6-point scale as follows: 0 = no problem, 1 = very mild problem, 2 = mild or slight problem, 3 = moderate problem, 4 = severe problem, 5 = problem as bad as it can be. The outcome measure is change from baseline in total patient-reported outcome score. The SNOT-22 total score is the sum of individual scores and ranges from 0 to 110. Higher scores indicate higher severity of symptoms.	Through Week 28
Change From Baseline in the Average Composite Score Over the Preceeding 7 Days of the 3 Cardinal Symptoms (3CS)	Change from baseline in the average composite score over the preceeding 7 days of the 3 Cardinal Symptoms (3CS).The 3CS include: nasal blockage/obstruction/congestion, facial pain/ pressure, and anterior/posterior nasal discharge. The diary is completed daily by study participants throughout the study. Each symptom/each question is scored daily on a 0-3 scale as follows: 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The 3CS total score ranges from 0-9, with higher scores indicating worse symptoms.	Through Week 28

Collaborators and Investigators

• Sponsor: Lyra Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2021
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: September 1, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Paranasal Sinus Diseases; Rhinosinusitis; Sinusitis
• Other Study ID Numbers: LYR-220-2021-001

Drug and device information, study documents

• 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