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

Chronic Sinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05035654
• Other study ID #: LYR-220-2021-001
• Status: Completed
• Phase: Phase 2
• Start date: November 23, 2021
• Est. completion date: August 30, 2023

Study information

• Verified date: February 2023
• Source: Lyra Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Rhinosinusitis (Diagnosis)
• Chronic Sinusitis
• Sinusitis

Intervention

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

Locations

Country	Name	City	State
Australia	Lyra Investigational Site	Bedford Park
Australia	Lyra Investigational Site	Brisbane
Australia	Lyra Investigational Site	Melbourne
United States	Lyra Investigational Site	Baltimore	Maryland
United States	Lyra Investigational Site	Bethlehem	Pennsylvania
United States	Lyra Investigational Site	Carlsbad	California
United States	Lyra Investigational Site	Chapel Hill	North Carolina
United States	Lyra Investigational Site	Chicago	Illinois
United States	Lyra Investigational Site	Chicago	Illinois
United States	Lyra Investigational Site	Fort Worth	Texas
United States	Lyra Investigational Site	La Mesa	California
United States	Lyra Investigational Site	Louisville	Kentucky
United States	Lyra Investigational Site	Marrero	Louisiana
United States	Lyra Investigational Site	McKinney	Texas
United States	Lyra Investigational Site	New Albany	Indiana
United States	Lyra Investigational Site	New Hyde Park	New York
United States	Lyra Investigational Site	New York	New York
United States	Lyra Investigational Site	Orangeburg	South Carolina
United States	Lyra Investigational Site	Roseville	California
United States	Lyra Investigational Site	San Antonio	Texas
United States	Lyra Investigational Site	South Ogden	Utah
United States	Lyra Investigational Site	Spartanburg	South Carolina
United States	Lyra Investigational Site	Spokane	Washington
United States	Lyra Investigational Site	Torrance	California
United States	Lyra Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Lyra Therapeutics

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Product-related unexpected serious adverse events	Product-related unexpected serious adverse events	Through Week 28
Primary	Plasma MF concentrations	Plasma MF concentrations	Through Week 25
Secondary	Adverse Events	Severity and percentage of subjects reporting treatment-emergent adverse events and serious adverse events	Through Week 28
Secondary	Laboratory Values (hematology and chemistry)	Percentage of subjects with abnormal and clinically significant abnormal laboratory values	Through Week 25
Secondary	Endoscopic findings	Percentage of subjects with newly identified or worsened endoscopic findings in the ethmoid cavity (mild, moderate, or severe)	Through Week 25
Secondary	Ophthalmic Assessment: Intraocular Pressure (IOP)	Percentage of subjects with clinically significant increase in IOP	Through Week 25
Secondary	Ophthalmic Assessment: Cataract	Percentage of subjects with newly identified or worsened cataract in one or both eyes	Through Week 25
Secondary	Improving Chronic Rhinosinusitis (CRS) specific Quality of Life as per the 22-item sino-nasal outcome test (SNOT-22) questionnaire	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.	Through Week 28
Secondary	Change in Chronic Rhinosinusitis (CRS) symptom scores	Change from baseline in the average composite score	Through Week 28