NCT05035654

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Lyra Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Sinusitis
• Chronic Rhinosinusitis (Diagnosis)

Interventions

Type	Name	Description
DRUG	LYR-220 Design 1 (Part 1 only)	LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1
DRUG	LYR-220 Design 2 (Part 1 and Part 2)	LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2
DRUG	Bilateral sham procedure control (Part 2)	Bilateral sham procedure control

Timeline

• Start date: 2021-11-23
• Primary completion: 2023-08-30
• Completion: 2023-08-30
• First posted: 2021-09-05
• Last updated: 2024-12-17
• Results posted: 2024-12-17

Locations

25 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study