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

Overview

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.

Full Title of 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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: August 30, 2023

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.

Interventions

  • Drug: LYR-220 Design 1
    • LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1
  • Drug: LYR-220 Design 2
    • LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2
  • Drug: Bilateral sham procedure control
    • Bilateral sham procedure control

Arms, Groups and Cohorts

  • Experimental: Treatment Arm A: LYR-220 Design 1
    • Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1
  • Experimental: Treatment Arm B: LYR-220 Design 2
    • Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2
  • Sham Comparator: Treatment Arm C: Bilateral sham procedure control
    • Bilateral sham procedure control

Clinical Trial Outcome Measures

Primary Measures

  • Product-related unexpected serious adverse events
    • Time Frame: Through Week 28
    • Product-related unexpected serious adverse events
  • Plasma MF concentrations
    • Time Frame: Through Week 25
    • Plasma MF concentrations

Secondary Measures

  • Adverse Events
    • Time Frame: Through Week 28
    • Severity and percentage of subjects reporting treatment-emergent adverse events and serious adverse events
  • Laboratory Values (hematology and chemistry)
    • Time Frame: Through Week 25
    • Percentage of subjects with abnormal and clinically significant abnormal laboratory values
  • Endoscopic findings
    • Time Frame: Through Week 25
    • Percentage of subjects with newly identified or worsened endoscopic findings in the ethmoid cavity (mild, moderate, or severe)
  • Ophthalmic Assessment: Intraocular Pressure (IOP)
    • Time Frame: Through Week 25
    • Percentage of subjects with clinically significant increase in IOP
  • Ophthalmic Assessment: Cataract
    • Time Frame: Through Week 25
    • 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
    • Time Frame: Through Week 28
    • 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
    • Time Frame: Through Week 28
    • Change from baseline in the average composite score

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lyra Therapeutics
  • Provider of Information About this Clinical Study
    • Sponsor

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