Clinical trial NCT05295459: Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 2)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Sinusitis
Chronic Rhinosinusitis (Diagnosis)
Lead sponsor: Lyra Therapeutics
Sponsor class: INDUSTRY
First posted: 2022-03-25
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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.
timeFrame: Week 24
Secondary outcomes:
measure: CFBL in the 7-day average composite score of 3CS at Week 24.
timeFrame: Week 24
measure: CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) total score at Week 24.
timeFrame: Week 24
measure: CFBL in the percent opacification of the bilateral anterior and posterior ethmoids at Week 20, as determined by 3-D volumetric CT analysis.
timeFrame: Week 20
measure: Rescue treatment requirement through Week 24.
timeFrame: Week 24
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Novak Clinical Trials
state: Arizona
city: Arcadia
country: United States
facility: Keck School of Medicine at USC Medical Center
state: California
city: Los Angeles
country: United States
facility: Sensa Health Clinical Research
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Orange
country: United States
facility: University of California - Irvine Medical Center
state: California
city: Roseville
country: United States
facility: Sacramento Ear Nose and Throat Surgical and Medical Group, Inc
state: California
city: Sacramento
country: United States
facility: University of California - Davis
state: California
city: San Diego
country: United States
facility: Regional Head & Neck Consulting - SENTA Clinic
state: California
city: Torrance
country: United States
facility: Breathe Clear Institute
state: California
city: Colorado Springs
country: United States
facility: Colorado ENT and Allergy
state: Colorado
city: Boynton Beach
country: United States
facility: Ear, Nose and Throat Associates of South Florida, P.A.
state: Florida
city: Brandon
country: United States
facility: ENT and Allergy Associates of Florida - Brandon
state: Florida
city: Plantation
country: United States
facility: ENT and Allergy Associates of Florida - Plantation - Dr. Johnson
state: Florida
city: Plantation
country: United States
facility: ENT and Allergy Associates of Florida - Plantation - Dr. Wright
state: Florida
city: Port Saint Lucie
country: United States
facility: ENT and Allergy Associates of Florida
state: Florida
city: Chicago
country: United States
facility: The University of Chicago Medical Center (UCMC)
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Fairway
country: United States
facility: University of Kansas Medical Center (KUMC)
state: Kansas
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
city: Saint Louis
country: United States
facility: St Louis University
state: Missouri
city: New York
country: United States
facility: ENT and Allergy Associates, LLP - Fifth Avenue New York
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: White Plains
country: United States
facility: ENT and Allergy Associates - White Plains
state: New York
city: Orangeburg
country: United States
facility: Carolina Ear, Nose, & Throat Clinic/CENTRI, Inc.
state: South Carolina
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: McKinney
country: United States
facility: ENT Associates of Texas
state: Texas
city: Ogden
country: United States
facility: Lyra Investigational Site
state: Utah
city: Richmond
country: United States
facility: Lyra Investigational Site
state: Virginia
city: Gent
country: Belgium
facility: University Hospital Gent
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
city: Burgas
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment
city: Plovdiv
country: Bulgaria
facility: UMHAT Kaspela Ltd
city: Sofia
country: Bulgaria
facility: Military Medical Academy Multiprofile Hospital
city: Varna
country: Bulgaria
facility: Diagnostic and Consulting Center Mladost - Varna
city: Baden
country: Germany
facility: HNO Praxis Dr. Andrea Kienle-Gogolok
city: Berlin
country: Germany
facility: HNO Zentrum am Kudamm
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden
city: Landsberg
country: Germany
facility: HNO Landsberg
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Budapest
country: Hungary
facility: Semmelweis Egyetem - Nyaksebeszeti Klinika
city: Budapest
country: Hungary
facility: Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
city: Budapest
country: Hungary
facility: Szent Imre Korhaz
city: Budapest
country: Hungary
facility: Eszak-Pesti Centrumkorhaz - Honvedkorhaz
city: Budapest
country: Hungary
facility: Budapesti Uzsoki Utcai Korhaz
city: Nyíregyháza
country: Hungary
facility: Lyra Investigational Site
city: Pécs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont
city: Tatabánya
country: Hungary
facility: Komarom-Esztergom Varmegyei Szent Borbala Korhaz
city: Białystok
country: Poland
facility: Sleepmedica
city: Inowrocław
country: Poland
facility: "Farma-Med." Kujawskie Centrum Medyczne Sp. z o.o.
city: Krakow
country: Poland
facility: Promed P.Lach R.Glowacki Spolka Jawna
city: Lublin
country: Poland
facility: Velocity Lublin
city: Warszawa
country: Poland
facility: Mazowiecki Szpital Brodnowski Sp. z o.o. - Zespol Oddzialow Otolaryngologii
city: Warszawa
country: Poland
facility: Lyra Investigational Site
city: Wrocław
country: Poland
facility: Panstwowy Instytut Medyczny MSWiA - Klinika Otolaryngologii
Study officials:
References: