Clinical trial NCT05035654: LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Sinusitis
Chronic Rhinosinusitis (Diagnosis)
Lead sponsor: Lyra Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-09-05
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Product-related Unexpected Serious Adverse Events
timeFrame: Through Week 28
measure: Plasma MF Concentrations
timeFrame: Through Week 25
Secondary outcomes:
measure: Adverse Events
timeFrame: Through Week 28
measure: Endoscopic Findings
timeFrame: Through Week 25
measure: Ophthalmic Assessment: Intraocular Pressure (IOP)
timeFrame: Through Week 25
measure: Ophthalmic Assessment: Cataract
timeFrame: Through Week 25
measure: Improving Chronic Rhinosinusitis (CRS) Specific Quality of Life as Per the 22-item Sino-nasal Outcome Test (SNOT-22) Questionnaire
timeFrame: Through Week 28
measure: Change From Baseline in the Average Composite Score Over the Preceeding 7 Days of the 3 Cardinal Symptoms (3CS)
timeFrame: Through Week 28
Other outcomes:
Locations:
city: Carlsbad
country: United States
facility: Lyra Investigational Site
state: California
city: La Mesa
country: United States
facility: Lyra Investigational Site
state: California
city: Roseville
country: United States
facility: Lyra Investigational Site
state: California
city: Torrance
country: United States
facility: Lyra Investigational Site
state: California
city: Chicago
country: United States
facility: Lyra Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Lyra Investigational Site
state: Illinois
city: New Albany
country: United States
facility: Lyra Investigational Site
state: Indiana
city: Louisville
country: United States
facility: Lyra Investigational Site
state: Kentucky
city: Marrero
country: United States
facility: Lyra Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Lyra Investigational Site
state: Maryland
city: New Hyde Park
country: United States
facility: Lyra Investigational Site
state: New York
city: New York
country: United States
facility: Lyra Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: Lyra Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Lyra Investigational Site
state: North Carolina
city: Bethlehem
country: United States
facility: Lyra Investigational Site
state: Pennsylvania
city: Orangeburg
country: United States
facility: Lyra Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: Lyra Investigational Site
state: South Carolina
city: Fort Worth
country: United States
facility: Lyra Investigational Site
state: Texas
city: McKinney
country: United States
facility: Lyra Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Lyra Investigational Site
state: Texas
city: South Ogden
country: United States
facility: Lyra Investigational Site
state: Utah
city: Spokane
country: United States
facility: Lyra Investigational Site
state: Washington
city: Bedford Park
country: Australia
facility: Lyra Investigational Site
city: Brisbane
country: Australia
facility: Lyra Investigational Site
city: Melbourne
country: Australia
facility: Lyra Investigational Site
Study officials:
References: