Trial · NCT05295459

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

NCT05295459, Phase 3, Completed, Lyra Therapeutics; results first posted 2026-02-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 2). Trials, record NCT05295459. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05295459

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 2)
NCT number: NCT05295459
Status: Completed
Phases: Phase 3
Enrollment: 182 participants, actual
Lead sponsor: Lyra Therapeutics
Conditions: Chronic Sinusitis, Chronic Rhinosinusitis (Diagnosis)
Interventions: LYR-210, Sham procedure control, Background therapy
First posted: 2022-03-25
Last updated: 2026-02-19
Results first posted: 2026-02-19
Limitations and caveats: Due to the nature of the procedure, the treating Investigator/surgeon was not blinded to the treatment assignment. Efforts were made to keep the study coordinator and other study staff blinded.

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline (CFBL) in the 7-day Average Composite Score of 3 Cardinal Symptoms (3CS) in Participants Without Nasal Polyps	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.
Secondary	CFBL in the 7-day Average Composite Score of 3CS in All Participants at Week 24	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.
Secondary	CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) Total Score at Week 24	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.
Secondary	CFBL in the 3-D Volumetric CT Score at Week 20	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.
Secondary	Rescue Treatment Requirement Through Week 24	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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline (CFBL) in the 7-day Average Composite Score of 3 Cardinal Symptoms (3CS) in Participants Without Nasal Polyps	Week 24	ITT Analysis Set Without Nasal Polyps	Change from Baseline in 3CS Score	LEAST_SQUARES_MEAN
SECONDARY	CFBL in the 7-day Average Composite Score of 3CS in All Participants at Week 24	Week 24	ITT Analysis Set	Change from Baseline in 3CS Score	LEAST_SQUARES_MEAN
SECONDARY	CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) Total Score at Week 24	Week 24	ITT Analysis Set	Change from Baseline in SNOT-22 Score	LEAST_SQUARES_MEAN
SECONDARY	CFBL in the 3-D Volumetric CT Score at Week 20	Week 20	ITT Analysis Set	Percent ethmoid opacification	LEAST_SQUARES_MEAN
SECONDARY	Rescue Treatment Requirement Through Week 24	Week 24	ITT Analysis Set	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline (CFBL) in the 7-day Average Composite Score of 3 Cardinal Symptoms (3CS) in Participants Without Nasal Polyps	LYR-210	-2.73	Standard Error 0.239	Change from Baseline in 3CS Score
Change From Baseline (CFBL) in the 7-day Average Composite Score of 3 Cardinal Symptoms (3CS) in Participants Without Nasal Polyps	Sham Procedure Control	-1.61	Standard Error 0.332	Change from Baseline in 3CS Score
CFBL in the 7-day Average Composite Score of 3CS in All Participants at Week 24	LYR-210	-2.62	Standard Error 0.229	Change from Baseline in 3CS Score
CFBL in the 7-day Average Composite Score of 3CS in All Participants at Week 24	Sham Procedure Control	-1.72	Standard Error 0.305	Change from Baseline in 3CS Score
CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) Total Score at Week 24	LYR-210	-22.4	Standard Error 2.05	Change from Baseline in SNOT-22 Score
CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) Total Score at Week 24	Sham Procedure Control	-13.7	Standard Error 2.61	Change from Baseline in SNOT-22 Score
CFBL in the 3-D Volumetric CT Score at Week 20	LYR-210	-2.70	Standard Error 0.962	Percent ethmoid opacification
CFBL in the 3-D Volumetric CT Score at Week 20	Sham Procedure Control	-0.55	Standard Error 1.271	Percent ethmoid opacification
Rescue Treatment Requirement Through Week 24	LYR-210	12		Participants
Rescue Treatment Requirement Through Week 24	Sham Procedure Control	7		Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	LYR-210	121
Overall Study	STARTED	Sham Procedure Control	61
Overall Study	COMPLETED	LYR-210	99
Overall Study	COMPLETED	Sham Procedure Control	58
Overall Study	NOT COMPLETED	LYR-210	22
Overall Study	NOT COMPLETED	Sham Procedure Control	3

Source ClinicalTrials.gov

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Acute sinusitis	Infections and infestations	LYR-210	10	112	12
other	Acute sinusitis	Infections and infestations	Sham Procedure Control	2	60	3
other	COVID-19	Infections and infestations	LYR-210	5	112	5
other	COVID-19	Infections and infestations	Sham Procedure Control	4	60	4
other	Chronic sinusitis	Infections and infestations	LYR-210	8	112	10
other	Chronic sinusitis	Infections and infestations	Sham Procedure Control	6	60	8
other	Nasopharyngitis	Infections and infestations	LYR-210	7	112	8
other	Nasopharyngitis	Infections and infestations	Sham Procedure Control	4	60	4
other	Upper respiratory tract infection	Infections and infestations	LYR-210	10	112	11
other	Upper respiratory tract infection	Infections and infestations	Sham Procedure Control	5	60	5

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	LYR-210	0	112
Total, all-cause mortality	Sham Procedure Control	0	60
Total, other adverse events	LYR-210	48	112
Total, other adverse events	Sham Procedure Control	17	60
Total, serious adverse events	LYR-210	2	112
Total, serious adverse events	Sham Procedure Control	0	60

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
LYR-210 vs Sham Procedure Control: Rescue Treatment Requirement Through Week 24	Trial comparisons
LYR-210 vs Sham Procedure Control: deaths from any cause	Trial comparisons
LYR-210 vs Sham Procedure Control: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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