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

NCT05035654 | Completed Phase 2 Results FDA Drug

• 1 other identifier: LYR-220-2021-001
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 25

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.

Conditions

Chronic Sinusitis; Chronic Rhinosinusitis (Diagnosis)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Adverse Events

  Through Week 28

• Endoscopic Findings

  Through Week 25

• Ophthalmic Assessment: Intraocular Pressure (IOP)

  Through Week 25

• Ophthalmic Assessment: Cataract

  Through Week 25

• Improving Chronic Rhinosinusitis (CRS) Specific Quality of Life as Per the 22-item Sino-nasal Outcome Test (SNOT-22) Questionnaire

  Through Week 28

Study Arms (3)

Part 1: Treatment Arm LYR-220 Design 1

EXPERIMENTAL

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

Drug: LYR-220 Design 1 (Part 1 only)

Part 1 and Part 2: Treatment Arm LYR-220 Design 2

EXPERIMENTAL

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

Drug: LYR-220 Design 2 (Part 1 and Part 2)

Part 2: Treatment Arm Bilateral sham procedure control

SHAM COMPARATOR

Bilateral sham procedure control

Drug: Bilateral sham procedure control (Part 2)

Interventions

LYR-220 Design 1 (Part 1 only) DRUG

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

Part 1: Treatment Arm LYR-220 Design 1

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

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

Part 1 and Part 2: Treatment Arm LYR-220 Design 2

Bilateral sham procedure control (Part 2) DRUG

Bilateral sham procedure control

Part 2: Treatment Arm Bilateral sham procedure control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lyra Therapeutics: lead

Study Sites (25)

Lyra Investigational Site

Carlsbad, California, 92008, United States

Location

Lyra Investigational Site

La Mesa, California, 91942, United States

Location

Lyra Investigational Site

Roseville, California, 95661, United States

Location

Lyra Investigational Site

Torrance, California, 90501, United States

Location

Lyra Investigational Site

Chicago, Illinois, 60208, United States

Location

Lyra Investigational Site

Chicago, Illinois, 60657, United States

Location

Lyra Investigational Site

New Albany, Indiana, 47150, United States

Location

Lyra Investigational Site

Louisville, Kentucky, 40205, United States

Location

Lyra Investigational Site

Marrero, Louisiana, 70072, United States

Location

Lyra Investigational Site

Baltimore, Maryland, 21204, United States

Location

Lyra Investigational Site

New Hyde Park, New York, 11042, United States

Location

Lyra Investigational Site

New York, New York, 10016, United States

Location

Lyra Investigational Site

Chapel Hill, North Carolina, 27599, United States

Location

Lyra Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

Lyra Investigational Site

Bethlehem, Pennsylvania, 18017, United States

Location

Lyra Investigational Site

Orangeburg, South Carolina, 29118, United States

Location

Lyra Investigational Site

Spartanburg, South Carolina, 29303, United States

Location

Lyra Investigational Site

Fort Worth, Texas, 76109, United States

Location

Lyra Investigational Site

McKinney, Texas, 75069, United States

Location

Lyra Investigational Site

San Antonio, Texas, 78258, United States

Location

Lyra Investigational Site

South Ogden, Utah, 84405, United States

Location

Lyra Investigational Site

Spokane, Washington, 99201, United States

Location

Lyra Investigational Site

Bedford Park, 5042, Australia

Location

Lyra Investigational Site

Brisbane, Australia

Location

Lyra Investigational Site

Melbourne, Australia

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Vice President, Clinical Affairs
• Organization: Lyra Therapeutics

lyraclinical@lyratx.com

617-393-4600

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 5, 2021
• Study Start: November 23, 2021
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: December 17, 2024
• Results First Posted: December 17, 2024

Record last verified: 2024-11

Locations

US (22); AU (3)