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

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Sinusitis, Chronic Rhinosinusitis (Diagnosis)

In brief

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

Key facts

Study ID

NCT05295459

Run by

Lyra Therapeutics

People needed

182

Starts

2022-05-13

Expected to finish

2025-04-02

Last updated by the study team

2026-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• Keck School of Medicine at USC Medical Center — Arcadia, California, United States
• Sensa Health Clinical Research — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of California - Irvine Medical Center — Orange, California, United States
• Sacramento Ear Nose and Throat Surgical and Medical Group, Inc — Roseville, California, United States
• University of California - Davis — Sacramento, California, United States
• Regional Head & Neck Consulting - SENTA Clinic — San Diego, California, United States
• Breathe Clear Institute — Torrance, California, United States
• Colorado ENT and Allergy — Colorado Springs, Colorado, United States
• Ear, Nose and Throat Associates of South Florida, P.A. — Boynton Beach, Florida, United States
• ENT and Allergy Associates of Florida - Brandon — Brandon, Florida, United States
• ENT and Allergy Associates of Florida - Plantation - Dr. Johnson — Plantation, Florida, United States
• ENT and Allergy Associates of Florida - Plantation - Dr. Wright — Plantation, Florida, United States
• ENT and Allergy Associates of Florida — Port Saint Lucie, Florida, United States
• The University of Chicago Medical Center (UCMC) — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Kansas Medical Center (KUMC) — Fairway, Kansas, United States
• Tandem Clinical Research — Marrero, Louisiana, United States
• Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States
• University of Missouri-Columbia — Columbia, Missouri, United States
• St Louis University — St Louis, Missouri, United States
• ENT and Allergy Associates, LLP - Fifth Avenue New York — New York, New York, United States
• Columbia University — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• Novak Clinical Trials — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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