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Chronic SinusitisPhase 3NCT05295459

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

A Phase 3 study testing LYR-210 and Background therapy in people with Chronic Sinusitis and Chronic Rhinosinusitis (Diagnosis), run by Lyra Therapeutics at 57 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Multicenter, phase III, randomized, blinded, controlled, parallel group. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
LYR-210 and Background therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
182 participants
Where
57 sitesin 6 countries
Study dates
13 May 2022to 2 Apr 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18
  • Diagnosed as having CRS
  • Bilateral ethmoid disease confirmed on CT
  • Mean 3 cardinal symptom (3CS) score
  • Undergone at least 2 trials of medical treatments in the past
  • Has been informed of the nature of the study and provided written informed consent
  • Agrees to comply with all study requirements
  • If currently on a waiting list for sinonasal surgery, willing to be removed from the waiting list or have preplanned surgery date cancelled for the duration of the study. [Note: this does not preclude a participant from receiving or being recommended for sinonasal surgery as rescue treatment during the study].

Who cannot join

  • Inability to tolerate topical anesthesia
  • Previous nasal surgery
  • Presence of nasal polyp grade 2 or higher
  • Seasonal allergic rhinitis
  • Perennial rhinitis with symptoms that are well controlled by regular use of intranasal corticosteroids
  • Severe asthma
Show all 22Show fewer
  • History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, atrophic rhinitis, or odontogenic sinusitis
  • Obstruction preventing proper placement and retention of LYR-210 as seen on endoscopy
  • Anatomic variation that, in the opinion of the investigator, would adversely impact placement of LYR-210 as seen on CT
  • Known history of hypersensitivity or intolerance to corticosteroids
  • Known history of hypothalamic pituitary adrenal axial dysfunction
  • Previous pituitary or adrenal surgery
  • Dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
  • Past or present acute or chronic intracranial or orbital complications of CRS
  • History or diagnosis (in either eye) of glaucoma or ocular hypertension
  • Past or present functional vision in only 1 eye
  • Past, present, or planned organ transplant or chemotherapy with immunosuppression
  • Currently positive for COVID-19 or residual sinonasal symptoms from a previous COVID-19 infection
  • Pregnant or breast feeding. Females of child-bearing potential must test negative for pregnancy at the time of screening
  • Evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments
  • Currently participating in an investigational drug or device study
  • Determined by the investigator as not suitable to be enrolled

Trial locations and contacts

57 sites in 6 countries.

57 sites in 6 countries

United States31 sites

  • Keck School of Medicine at USC Medical Center

    Arcadia, California, 91007

  • Massachusetts Eye and Ear Infirmary

    Boston, Massachusetts, 02114

  • Ear, Nose and Throat Associates of South Florida, P.A.

    Boynton Beach, Florida, 33426

  • ENT and Allergy Associates of Florida - Brandon

    Brandon, Florida, 33511

  • The University of Chicago Medical Center (UCMC)

    Chicago, Illinois, 60637

  • Colorado ENT and Allergy

    Colorado Springs, Colorado, 80909

  • University of Missouri-Columbia

    Columbia, Missouri, 65212

  • University of Kansas Medical Center (KUMC)

    Fairway, Kansas, 66205

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202

  • Sensa Health Clinical Research

    Los Angeles, California, 90006

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Tandem Clinical Research

    Marrero, Louisiana, 70072

  • ENT Associates of Texas

    McKinney, Texas, 75070

  • ENT and Allergy Associates, LLP - Fifth Avenue New York

    New York, New York, 10016

  • Columbia University

    New York, New York, 10032

  • Lyra Investigational Site

    Ogden, Utah, 84405

  • University of California - Irvine Medical Center

    Orange, California, 92868

  • Carolina Ear, Nose, & Throat Clinic/CENTRI, Inc.

    Orangeburg, South Carolina, 29118

  • ENT and Allergy Associates of Florida - Plantation - Dr. Johnson

    Plantation, Florida, 33324

  • ENT and Allergy Associates of Florida - Plantation - Dr. Wright

    Plantation, Florida, 33324

  • ENT and Allergy Associates of Florida

    Port Saint Lucie, Florida, 34952

  • Lyra Investigational Site

    Richmond, Virginia, 23235

  • University of Rochester

    Rochester, New York, 14642

  • Sacramento Ear Nose and Throat Surgical and Medical Group, Inc

    Roseville, California, 95661

  • University of California - Davis

    Sacramento, California, 95817

  • Regional Head & Neck Consulting - SENTA Clinic

    San Diego, California, 92108

  • St Louis University

    St Louis, Missouri, 63104

  • Breathe Clear Institute

    Torrance, California, 90503

  • Novak Clinical Trials

    Tucson, Arizona, 85741

  • ENT and Allergy Associates - White Plains

    White Plains, New York, 10605

Other trials in United States

Hungary8 sites

  • Semmelweis Egyetem - Nyaksebeszeti Klinika

    Budapest, 1083

  • Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet

    Budapest, 1106

  • Szent Imre Korhaz

    Budapest, 1115

  • Eszak-Pesti Centrumkorhaz - Honvedkorhaz

    Budapest, 1134

  • Budapesti Uzsoki Utcai Korhaz

    Budapest, 1145

  • Lyra Investigational Site

    Nyíregyháza

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs

  • Komarom-Esztergom Varmegyei Szent Borbala Korhaz

    Tatabánya

Other trials in Hungary

Poland7 sites

  • Sleepmedica

    Bialystok

  • "Farma-Med." Kujawskie Centrum Medyczne Sp. z o.o.

    Inowrocław

  • Promed P.Lach R.Glowacki Spolka Jawna

    Krakow, 31-411

  • Velocity Lublin

    Lublin, 20-362

  • Mazowiecki Szpital Brodnowski Sp. z o.o. - Zespol Oddzialow Otolaryngologii

    Warsaw, 02-507

  • Lyra Investigational Site

    Warsaw, 03-242

  • Panstwowy Instytut Medyczny MSWiA - Klinika Otolaryngologii

    Wroclaw, 53-149

Other trials in Poland

Germany5 sites

  • HNO Praxis Dr. Andrea Kienle-Gogolok

    Baden, 76669

  • HNO Zentrum am Kudamm

    Berlin

  • Universitaetsklinikum Carl Gustav Carus Dresden

    Dresden

  • HNO Landsberg

    Landsberg

  • Universitaetsklinikum Tuebingen

    Tübingen

Other trials in Germany

Bulgaria4 sites

  • University Multiprofile Hospital for Active Treatment

    Burgas

  • UMHAT Kaspela Ltd

    Plovdiv

  • Military Medical Academy Multiprofile Hospital

    Sofia

  • Diagnostic and Consulting Center Mladost - Varna

    Varna

Other trials in Bulgaria

Belgium2 sites

  • University Hospital Gent

    Ghent

  • Universitaire Ziekenhuizen Leuven

    Leuven

Other trials in Belgium

About this study

Official title: 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

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

Read the 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.

Being tested
LYR-210, Sham procedure control, Background therapy
Medical subject headings
Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LYR-210Drug

    LYR-210 drug matrix (mometasone furoate)

  • Sham procedure controlDrug

    Sham procedure control

  • Background therapyOther

    Daily Saline Irrigation

Study groups in NCT05295459
Study groupRoleWhat they receive
LYR-210ExperimentalSingle administration of LYR-210 drug matrix (7500 μg)
Receives: Drug: LYR-210; Other: Background therapy
Sham procedure controlSham comparatorSingle mock administration procedure
Receives: Drug: Sham procedure control; Other: Background therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline (CFBL) in the 7-day Average Composite Score of 3 Cardinal Symptoms (3CS) in Participants Without Nasal Polyps

    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.

    Measured: Week 24

Secondary outcomes (4)

  1. CFBL in the 7-day Average Composite Score of 3CS in All Participants at 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.

    Measured: Week 24

  2. CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) Total Score at 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.

    Measured: Week 24

  3. CFBL in the 3-D Volumetric CT Score at 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.

    Measured: Week 20

  4. Rescue Treatment Requirement Through 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.

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2022
  2. Study start13 May 2022
  3. Primary completion2 Apr 2025
  4. Study completion2 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05295459
Sponsor's protocol ID
LYR-210-2021-005
Status last verified
Jan 2026
First submitted
8 Mar 2022
Last updated
19 Feb 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LYR-210 and Background therapy in people with Chronic Sinusitis and Chronic Rhinosinusitis (Diagnosis), run by Lyra Therapeutics at 57 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Hungary, Poland, Germany, Bulgaria and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline (CFBL) in the 7-day Average Composite Score of 3 Cardinal Symptoms (3CS) in Participants Without Nasal Polyps (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05295459.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.

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