Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 2)
- Conditions
- Chronic SinusitisChronic Rhinosinusitis (Diagnosis)
- Interventions
- Drug: Sham procedure controlDrug: LYR-210Other: Background therapy
- Registration Number
- NCT05295459
- Lead Sponsor
- Lyra Therapeutics
- Brief Summary
Multicenter, phase III, randomized, blinded, controlled, parallel group.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 182
- 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].
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham procedure control Sham procedure control Single mock administration procedure Sham procedure control Background therapy Single mock administration procedure LYR-210 Background therapy Single administration of LYR-210 drug matrix (7500 μg) LYR-210 LYR-210 Single administration of LYR-210 drug matrix (7500 μg)
- Primary Outcome Measures
Name Time Method Change from baseline (CFBL) in the 7-day average composite score of 3 cardinal symptoms (3CS) of nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure at Week 24 in participants without nasal polyps. Week 24 The 3CS are nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. Each symptom is rated on a 4-point (0-3) scale where 0=absent symptoms and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores.
- Secondary Outcome Measures
Name Time Method CFBL in the 7-day average composite score of 3CS at Week 24. Week 24 The 3CS are nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. Each symptom is rated on a 4-point (0-3) scale where 0=absent symptoms and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores.
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.
CFBL in the percent opacification of the bilateral anterior and posterior ethmoids at Week 20, as determined by 3-D volumetric CT analysis. Week 20 Change from baseline in the 3-D volumetric CT score at Week 20.
Rescue treatment requirement through Week 24. Week 24 Number and percent of participants requiring rescue treatment through Week 24, this data will be conducted from pooled data from Enlighten 2 and the Enlighten I study.
Trial Locations
- Locations (54)
Novak Clinical Trials
🇺🇸Tucson, Arizona, United States
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
🇺🇸Saint 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
ENT and Allergy Associates - White Plains
🇺🇸White Plains, New York, United States
Carolina Ear, Nose, & Throat Clinic/CENTRI, Inc.
🇺🇸Orangeburg, South Carolina, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
ENT Associates of Texas
🇺🇸McKinney, Texas, United States
University Hospital Gent
🇧🇪Gent, Belgium
Lyra Investigational Site
🇵🇱Warszawa, Poland
Universitaire Ziekenhuizen Leuven
🇧🇪Leuven, Belgium
University Multiprofile Hospital for Active Treatment
🇧🇬Burgas, Bulgaria
UMHAT Kaspela Ltd
🇧🇬Plovdiv, Bulgaria
Military Medical Academy Multiprofile Hospital
🇧🇬Sofia, Bulgaria
Diagnostic and Consulting Center Mladost - Varna
🇧🇬Varna, Bulgaria
HNO Praxis Dr. Andrea Kienle-Gogolok
🇩🇪Baden, Germany
HNO Zentrum am Kudamm
🇩🇪Berlin, Germany
Universitaetsklinikum Carl Gustav Carus Dresden
🇩🇪Dresden, Germany
HNO Landsberg
🇩🇪Landsberg, Germany
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
Semmelweis Egyetem - Nyaksebeszeti Klinika
🇭🇺Budapest, Hungary
Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
🇭🇺Budapest, Hungary
Szent Imre Korhaz
🇭🇺Budapest, Hungary
Eszak-Pesti Centrumkorhaz - Honvedkorhaz
🇭🇺Budapest, Hungary
Budapesti Uzsoki Utcai Korhaz
🇭🇺Budapest, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
🇭🇺Pécs, Hungary
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
🇭🇺Tatabánya, Hungary
Sleepmedica
🇵🇱Białystok, Poland
"Farma-Med." Kujawskie Centrum Medyczne Sp. z o.o.
🇵🇱Inowrocław, Poland
Promed P.Lach R.Glowacki Spolka Jawna
🇵🇱Krakow, Poland
Velocity Lublin
🇵🇱Lublin, Poland
Mazowiecki Szpital Brodnowski Sp. z o.o. - Zespol Oddzialow Otolaryngologii
🇵🇱Warszawa, Poland
Panstwowy Instytut Medyczny MSWiA - Klinika Otolaryngologii
🇵🇱Wrocław, Poland