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NCT05295459

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

Completed Phase 3 Results posted Last updated 19 February 2026
What this trial tests

Phase 3 trial testing LYR-210 in Chronic Sinusitis in 182 participants. Completed in 2 April 2025.

Timeline
13 May 2022
Primary endpoint
2 April 2025
2 April 2025

Quick facts

Lead sponsorLyra Therapeutics
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment182
Start date13 May 2022
Primary completion2 April 2025
Estimated completion2 April 2025
Sites57 locations across Belgium, Germany, Hungary, Poland, Bulgaria, United States

Drugs / interventions tested

Conditions studied

Sponsor

Lyra Therapeutics — full company profile →

Who can join

18 and older, any sex, with Chronic Sinusitis or Chronic Rhinosinusitis (Diagnosis). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline (CFBL) in the 7-day Average Composite Score of 3 Cardinal Symptoms (3CS) in Participants Without Nasal Polyps Primary · Week 24

The 3CS are nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. The diary is completed daily by study participants throughout the study. Each symptom is rated on a 4-point (0-3) scale where 0= none/absent symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores. The 3CS total score ranges from 0-9, with higher scores indicating worse symptoms.

GroupValue95% CI
LYR-210-2.73± 0.239
Sham Procedure Control-1.61± 0.332
CFBL in the 7-day Average Composite Score of 3CS in All Participants at Week 24 Secondary · Week 24

The 3CS are nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. The diary is completed daily by study participants throughout the study. Each symptom is rated on a 4-point (0-3) scale where 0= none/absent symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores. The 3CS total score ranges from 0-9, with higher scores indicating worse symptoms.

GroupValue95% CI
LYR-210-2.62± 0.229
Sham Procedure Control-1.72± 0.305
CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) Total Score at Week 24 Secondary · Week 24

The SNOT-22 questionnaire is a 22-item disease-specific quality of life instrument. Each symptom is scored on a 6-point scale where 0 = no problem and 5 = problem as bad as it can be. The total SNOT-22 score is the sum of the 22 items and can range from 0 to 110 with higher scores indicating worse symptoms.

GroupValue95% CI
LYR-210-22.4± 2.05
Sham Procedure Control-13.7± 2.61
CFBL in the 3-D Volumetric CT Score at Week 20 Secondary · Week 20

Change from baseline in the percent opacification of the bilateral anterior and posterior ethmoids at Week 20, as determined by 3-D volumetric CT analysis. 3-D volumetric scoring involves evaluations of each slice of 3-D coronal CT sequences and summing of all the slices to create a volumetric score ranging from 0% to 100%. A negative change from Baseline indicates improvement from Baseline.

GroupValue95% CI
LYR-210-2.70± 0.962
Sham Procedure Control-0.55± 1.271
Rescue Treatment Requirement Through Week 24 Secondary · Week 24

Number and percent of participants requiring rescue treatment (systemic corticosteroid for any reason or participants that were recommended/underwent sinonasal surgery) through Week 24.

GroupValue95% CI
LYR-21012
Sham Procedure Control7

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events are reported from the time the informed consent form is signed until completion of all follow-up visits, up to Week 24.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

LYR-210
Serious: 2/112 (2%)
Deaths: 0/112
Sham Procedure Control
Serious: 0/60 (0%)
Deaths: 0/60

Serious adverse events (3 terms)

ReactionSystemLYR-210Sham Procedure Control
Lumbar spinal stenosisMusculoskeletal and connective tissue disorders
Colon adenomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Transient ischaemic attackNervous system disorders
Other adverse events (7 terms — click to expand)

ReactionSystemLYR-210Sham Procedure Control
EpistaxisRespiratory, thoracic and mediastinal disorders
Acute sinusitisInfections and infestations
Upper respiratory tract infectionInfections and infestations
Chronic sinusitisInfections and infestations
NasopharyngitisInfections and infestations
HeadacheNervous system disorders
COVID-19Infections and infestations

Most-reported serious reactions: Lumbar spinal stenosis, Colon adenoma, Transient ischaemic attack.

Data from ClinicalTrials.gov NCT05295459 adverse events section.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Primary Ciliary Dyskinesia.
    Wee WB, Kinghorn B, Davis SD, Ferkol TW, et al · · 2024 · cited 23× · PMID 38695103 · DOI 10.1542/peds.2023-063064

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Other trials of LYR-210

Trials testing the same drug.

Other Lyra Therapeutics trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05295459.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing