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.


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.