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

Lyra Therapeutics48 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Chronic Sinusitis Chronic Rhinosinusitis (Diagnosis)

Interventions

LYR-220 Design 1 (Part 1 only)DRUG

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

LYR-220 Design 2 (Part 1 and Part 2)DRUG

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

Bilateral sham procedure control (Part 2)DRUG

Bilateral sham procedure control

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (25)

Lyra Investigational Site

Carlsbad, California, United States

Outcomes

Primary Outcomes

Product-related Unexpected Serious Adverse Events

Product-related unexpected serious adverse events

Time frame: 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.

Time frame: Through Week 25

Secondary Outcomes

Adverse Events

Percentage of subjects reporting treatment-emergent adverse events

Time frame: Through Week 28

Endoscopic Findings

Percentage of subjects with newly identified or worsened endoscopic findings in the ethmoid cavity (mild, moderate, or severe)

Time frame: Through Week 25

Ophthalmic Assessment: Intraocular Pressure (IOP)

Percentage of subjects with clinically significant increase in IOP

Time frame: Through Week 25

Ophthalmic Assessment: Cataract

Percentage of subjects with newly identified or worsened cataract in one or both eyes

Time frame: 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.

Data from ClinicalTrials.gov

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