NCT05295459

Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 2)

ENLIGHTEN 2: A Phase III, Randomized, Blinded, Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Lyra Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, phase III, randomized, blinded, controlled, parallel group.

Detailed description

This is a 24-week, multicenter, phase III, randomized, blinded, controlled, parallel group with a 24-week treatment period 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: 2022-05-13
• Primary completion: 2025-04-02
• Completion: 2025-04-02
• First posted: 2022-03-25
• Last updated: 2026-02-19
• Results posted: 2026-02-19

Locations

57 sites across 6 countries: United States, Belgium, Bulgaria, Germany, Hungary, Poland

Regulatory

• FDA-regulated drug study