Phase 2
N=48
LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study)
Chronic Sinusitis · Chronic Rhinosinusitis (Diagnosis)
Bottom Line
View on ClinicalTrials.gov: NCT05035654 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Product-related Unexpected Serious Adverse Events — 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LYR-220 Design 1 (Part 1 only) (Drug); LYR-220 Design 2 (Part 1 and Part 2) (Drug); Bilateral sham procedure control (Part 2) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lyra Therapeutics
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Product-related Unexpected Serious Adverse Events |
0; 0; 0 | — |
| PRIMARY Plasma MF Concentrations |
11.04; 18.11; 40.86; 135.83; 61.02; 97.77 | — |
| SECONDARY Adverse Events |
1; 23; 16 | — |
| SECONDARY Endoscopic Findings |
0; 6; 3 | — |
| SECONDARY Ophthalmic Assessment: Intraocular Pressure (IOP) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Ophthalmic Assessment: Cataract |
0; 1; 0; 0; 1; 0 | — |
| SECONDARY Improving Chronic Rhinosinusitis (CRS) Specific Quality of Life as Per the 22-item Sino-nasal Outcome Test (SNOT-22) Questionnaire |
-30.1; -4.0 | — |
| SECONDARY Change From Baseline in the Average Composite Score Over the Preceeding 7 Days of the 3 Cardinal Symptoms (3CS) |
-1.68; -0.48 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT05035654). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.