LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study)
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 approximately 10 patients and is open label. Part 2 is randomized, sham controlled and will enroll approximately 60 patients. The study follow-up duration is 28 weeks.
- 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.
- 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.