Trial · NCT05219968

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

NCT05219968, Phase 3, Completed, Lyra Therapeutics; results first posted 2025-05-02

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. Trials, record NCT05219968. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05219968

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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
NCT number: NCT05219968
Status: Completed
Phases: Phase 3
Enrollment: 196 participants, actual
Lead sponsor: Lyra Therapeutics
Conditions: Chronic Sinusitis, Chronic Rhinosinusitis (Diagnosis)
Interventions: LYR-210, Sham procedure control, Background Therapy
First posted: 2022-02-02
Last updated: 2025-05-02
Results first posted: 2025-05-02

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.	24 Weeks	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/each question 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/each question 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	The percent opacification of the bilateral anterior and posterior ethmoids will be assessed by 3-D volumetric CT analysis at baseline and Week 20. A negative change from Baseline indicates improvement from Baseline.
Secondary	Participants With Rescue Treatments for CRS Through Week 24	Week 24	This endpoint is descriptively summarized per the prespecified plan. This includes participants that used systemic corticosteroid for any reason as well as participants that were recommended/underwent sinonasal surgery.

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.	24 Weeks	ITT Analysis Set Without Nasal Polyps	score on a scale	MEAN
SECONDARY	CFBL in the 7-day Average Composite Score of 3CS in All Participants at Week 24.	Week 24	ITT Analysis Set	score on a scale	MEAN
SECONDARY	CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) Total Score at Week 24	Week 24	ITT Analysis Set	score on a scale	MEAN
SECONDARY	CFBL in the 3-D Volumetric CT Score at Week 20	Week 20	ITT Analysis Set	Percent ethmoid opacification	MEAN
SECONDARY	Participants With Rescue Treatments for CRS 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	-2.13	Standard Deviation 2.172	score on a scale
Change From Baseline (CFBL) in the 7-day Average Composite Score of 3 Cardinal Symptoms (3CS) in Participants Without Nasal Polyps.	Sham Procedure Control	-2.06	Standard Deviation 2.136	score on a scale
CFBL in the 7-day Average Composite Score of 3CS in All Participants at Week 24.	LYR-210	-2.35	Standard Deviation 2.278	score on a scale
CFBL in the 7-day Average Composite Score of 3CS in All Participants at Week 24.	Sham Procedure Control	-1.83	Standard Deviation 2.104	score on a scale
CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) Total Score at Week 24	LYR-210	-19.7	Standard Deviation 21.67	score on a scale
CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) Total Score at Week 24	Sham Procedure Control	-15.7	Standard Deviation 18.55	score on a scale
CFBL in the 3-D Volumetric CT Score at Week 20	LYR-210	-2.705	Standard Deviation 10.9320	Percent ethmoid opacification
CFBL in the 3-D Volumetric CT Score at Week 20	Sham Procedure Control	-0.279	Standard Deviation 9.9706	Percent ethmoid opacification
Participants With Rescue Treatments for CRS Through Week 24	LYR-210	12		Participants
Participants With Rescue Treatments for CRS Through Week 24	Sham Procedure Control	7		Participants

Source ClinicalTrials.gov

Participant flow40

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

Period	Milestone	Group	Participants
Week 24 Treatment Period	STARTED	LYR-210	130
Week 24 Treatment Period	STARTED	Sham Procedure Control	66
Week 24 Treatment Period	STARTED	LYR-210 - LYR-210	0
Week 24 Treatment Period	STARTED	LYR-210 - Sham	0
Week 24 Treatment Period	STARTED	Sham - LYR-210	0
Week 24 Treatment Period	Entered Extension	LYR-210	84
Week 24 Treatment Period	Entered Extension	Sham Procedure Control	52
Week 24 Treatment Period	Entered Extension	LYR-210 - LYR-210	0
Week 24 Treatment Period	Entered Extension	LYR-210 - Sham	0
Week 24 Treatment Period	Entered Extension	Sham - LYR-210	0

1 to 10 of 40Source ClinicalTrials.gov

See all 40 participant flow

Adverse events155

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	Epistaxis	Respiratory, thoracic and mediastinal disorders	LYR-210 up to 24 Weeks	23	124	29
other	Epistaxis	Respiratory, thoracic and mediastinal disorders	Sham Procedure Control up to 24 Weeks	7	66	8
other	Epistaxis	Respiratory, thoracic and mediastinal disorders	LYR-210-LYR-210 Extension	6	42	8
other	Epistaxis	Respiratory, thoracic and mediastinal disorders	LYR-210-Sham Extension	2	41	2
other	Epistaxis	Respiratory, thoracic and mediastinal disorders	Sham-LYR-210 Extension	4	48	6
other	Nasal Odour	Respiratory, thoracic and mediastinal disorders	LYR-210 up to 24 Weeks	23	124	27
other	Nasal Odour	Respiratory, thoracic and mediastinal disorders	Sham Procedure Control up to 24 Weeks	0	66	0
other	Nasal Odour	Respiratory, thoracic and mediastinal disorders	LYR-210-LYR-210 Extension	6	42	7
other	Nasal Odour	Respiratory, thoracic and mediastinal disorders	LYR-210-Sham Extension	0	41	0
other	Nasal Odour	Respiratory, thoracic and mediastinal disorders	Sham-LYR-210 Extension	8	48	10

1 to 10 of 155Source ClinicalTrials.gov

See all 155 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	LYR-210 up to 24 Weeks	0	124
Total, all-cause mortality	Sham Procedure Control up to 24 Weeks	0	66
Total, all-cause mortality	LYR-210-LYR-210 Extension	0	42
Total, all-cause mortality	LYR-210-Sham Extension	0	41
Total, all-cause mortality	Sham-LYR-210 Extension	0	48
Total, other adverse events	LYR-210 up to 24 Weeks	78	124
Total, other adverse events	Sham Procedure Control up to 24 Weeks	26	66
Total, other adverse events	LYR-210-LYR-210 Extension	21	42
Total, other adverse events	LYR-210-Sham Extension	9	41
Total, other adverse events	Sham-LYR-210 Extension	19	48

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

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 comparisons1

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

Comparison
LYR-210 vs Sham Procedure Control: Participants With Rescue Treatments for CRS Through Week 24

Source 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.

GET https://conductscience.org/api/trials/v1/NCT05219968

GET https://conductscience.org/api/trials/v1/NCT05219968/flow?page=2

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