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

NCT05295459 | Completed Phase 3 Results FDA Drug

• 1 other identifier: LYR-210-2021-005
• Study Type: interventional
• Target: 182
• Locations: 6 countries
• Sites: 57

Brief Summary

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

Conditions

Chronic Sinusitis; Chronic Rhinosinusitis (Diagnosis)

Outcome Measures

Primary Outcomes (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.

  Week 24

Secondary Outcomes (4)

• CFBL in the 7-day Average Composite Score of 3CS in All Participants at Week 24

  Week 24

• CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) Total Score at Week 24

  Week 24

• CFBL in the 3-D Volumetric CT Score at Week 20

  Week 20

• Rescue Treatment Requirement Through Week 24

  Week 24

Study Arms (2)

LYR-210

EXPERIMENTAL

Single administration of LYR-210 drug matrix (7500 μg)

Drug: LYR-210; Other: Background therapy

Sham procedure control

SHAM COMPARATOR

Single mock administration procedure

Drug: Sham procedure control; Other: Background therapy

Interventions

LYR-210 DRUG

LYR-210 drug matrix (mometasone furoate)

LYR-210

Sham procedure control DRUG

Sham procedure control

Sham procedure control

Background therapy OTHER

Daily Saline Irrigation

LYR-210; Sham procedure control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. \[Note: this does not preclude a participant from receiving or being recommended for sinonasal surgery as rescue treatment during the study\].

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Lyra Therapeutics: lead

Study Sites (57)

Novak Clinical Trials

Tucson, Arizona, 85741, United States

Location

Keck School of Medicine at USC Medical Center

Arcadia, California, 91007, United States

Location

Sensa Health Clinical Research

Los Angeles, California, 90006, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California - Irvine Medical Center

Orange, California, 92868, United States

Location

Sacramento Ear Nose and Throat Surgical and Medical Group, Inc

Roseville, California, 95661, United States

Location

University of California - Davis

Sacramento, California, 95817, United States

Location

Regional Head & Neck Consulting - SENTA Clinic

San Diego, California, 92108, United States

Location

Breathe Clear Institute

Torrance, California, 90503, United States

Location

Colorado ENT and Allergy

Colorado Springs, Colorado, 80909, United States

Location

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

Boynton Beach, Florida, 33426, United States

Location

ENT and Allergy Associates of Florida - Brandon

Brandon, Florida, 33511, United States

Location

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

Plantation, Florida, 33324, United States

Location

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

Plantation, Florida, 33324, United States

Location

ENT and Allergy Associates of Florida

Port Saint Lucie, Florida, 34952, United States

Location

The University of Chicago Medical Center (UCMC)

Chicago, Illinois, 60637, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Medical Center (KUMC)

Fairway, Kansas, 66205, United States

Location

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

University of Missouri-Columbia

Columbia, Missouri, 65212, United States

Location

St Louis University

St Louis, Missouri, 63104, United States

Location

ENT and Allergy Associates, LLP - Fifth Avenue New York

New York, New York, 10016, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

ENT and Allergy Associates - White Plains

White Plains, New York, 10605, United States

Location

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

Orangeburg, South Carolina, 29118, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

ENT Associates of Texas

McKinney, Texas, 75070, United States

Location

Lyra Investigational Site

Ogden, Utah, 84405, United States

Location

Lyra Investigational Site

Richmond, Virginia, 23235, United States

Location

University Hospital Gent

Ghent, Belgium

Location

Universitaire Ziekenhuizen Leuven

Leuven, Belgium

Location

University Multiprofile Hospital for Active Treatment

Burgas, Bulgaria

Location

UMHAT Kaspela Ltd

Plovdiv, Bulgaria

Location

Military Medical Academy Multiprofile Hospital

Sofia, Bulgaria

Location

Diagnostic and Consulting Center Mladost - Varna

Varna, Bulgaria

Location

HNO Praxis Dr. Andrea Kienle-Gogolok

Baden, 76669, Germany

Location

HNO Zentrum am Kudamm

Berlin, Germany

Location

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, Germany

Location

HNO Landsberg

Landsberg, Germany

Location

Universitaetsklinikum Tuebingen

Tübingen, Germany

Location

Semmelweis Egyetem - Nyaksebeszeti Klinika

Budapest, 1083, Hungary

Location

Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet

Budapest, 1106, Hungary

Location

Szent Imre Korhaz

Budapest, 1115, Hungary

Location

Eszak-Pesti Centrumkorhaz - Honvedkorhaz

Budapest, 1134, Hungary

Location

Budapesti Uzsoki Utcai Korhaz

Budapest, 1145, Hungary

Location

Lyra Investigational Site

Nyíregyháza, Hungary

Location

Pecsi Tudomanyegyetem Klinikai Kozpont

Pécs, Hungary

Location

Komarom-Esztergom Varmegyei Szent Borbala Korhaz

Tatabánya, Hungary

Location

Sleepmedica

Bialystok, Poland

Location

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

Inowrocław, Poland

Location

Promed P.Lach R.Glowacki Spolka Jawna

Krakow, 31-411, Poland

Location

Velocity Lublin

Lublin, 20-362, Poland

Location

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

Warsaw, 02-507, Poland

Location

Lyra Investigational Site

Warsaw, 03-242, Poland

Location

Panstwowy Instytut Medyczny MSWiA - Klinika Otolaryngologii

Wroclaw, 53-149, Poland

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

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.

Results Point of Contact

• Title: Senior Vice President, Clinical Affairs
• Organization: Lyra Therapeutics

lyraclinical@lyratx.com

617-393-4600

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 25, 2022
• Study Start: May 13, 2022
• Primary Completion: April 2, 2025
• Study Completion: April 2, 2025
• Last Updated: February 19, 2026
• Results First Posted: February 19, 2026

Record last verified: 2026-01

Locations

PL (7); US (31); BE (2); BU (4); HU (8); DE (5)