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

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Sinusitis, Chronic Rhinosinusitis (Diagnosis)

In brief

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.

Key facts

Study ID

NCT05035654

Run by

Lyra Therapeutics

People needed

48

Starts

2021-11-23

Expected to finish

2023-08-30

Last updated by the study team

2024-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.