NCT05219968

Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults

ENLIGHTEN 1: A Phase III, Randomized, Blinded, Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis (CRS) in Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Lyra Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, phase III, randomized, blinded, controlled, parallel group with safety extension phase with crossover or continued treatment.

Detailed description

This is a 52-week, multicenter, phase III, randomized, blinded, controlled, parallel group with a 24-week treatment period followed by a safety extension phase with crossover or continued treatment to evaluate the efficacy and safety of LYR-210 compared with sham control for treatment in adults with CRS.

Conditions

• Chronic Sinusitis
• Chronic Rhinosinusitis (Diagnosis)

Interventions

Type	Name	Description
DRUG	LYR-210	LYR-210 drug matrix (mometasone furoate)
DRUG	Sham procedure control	Sham procedure control
OTHER	Background Therapy	Daily Saline Irrigation

Timeline

• Start date: 2022-01-27
• Primary completion: 2024-03-04
• Completion: 2024-09-16
• First posted: 2022-02-02
• Last updated: 2025-05-02
• Results posted: 2025-05-02

Locations

55 sites across 5 countries: United States, Austria, Czechia, Poland, Spain

Regulatory

• FDA-regulated drug study