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

Phase 2

Completed

• Conditions: Chronic Sinusitis; Chronic Rhinosinusitis (Diagnosis)
• Interventions: 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)

• Registration Number: NCT05035654
• Lead Sponsor: Lyra Therapeutics

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.

Study Timeline

• Study First Submitted: 2021-08-27
• Study First Submitted QC: 2021-09-01
• Study First Posted: 2021-09-05
• Study Start: 2021-11-23
• Primary Completion: 2023-08-30
• Study Completion: 2023-08-30
• Results First Submitted: 2024-09-12
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-21
• Last Update Submitted: 2024-11-21
• Results First Posted: 2024-12-17
• Last Update Posted: 2024-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 1: Treatment Arm LYR-220 Design 1	LYR-220 Design 1 (Part 1 only)	Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1
Part 1 and Part 2: Treatment Arm LYR-220 Design 2	LYR-220 Design 2 (Part 1 and Part 2)	Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2
Part 2: Treatment Arm Bilateral sham procedure control	Bilateral sham procedure control (Part 2)	Bilateral sham procedure control

Primary Outcome Measures

Name	Time	Method
Product-related Unexpected Serious Adverse Events	Through Week 28	Product-related unexpected serious adverse events
Plasma MF Concentrations	Through Week 25	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.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	Through Week 28	Percentage of subjects reporting treatment-emergent adverse events
Endoscopic Findings	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)	Through Week 25	Percentage of subjects with clinically significant increase in IOP
Ophthalmic Assessment: Cataract	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	Through Week 28	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.
Change From Baseline in the Average Composite Score Over the Preceeding 7 Days of the 3 Cardinal Symptoms (3CS)	Through Week 28	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.

Trial Locations

Locations (1)

Lyra Investigational Site; 🇦🇺 Melbourne, Australia