Clinical trial NCT05219968: Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults
Official title: ENLIGHTEN 1: A Phase III, Randomized, Blinded, Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis (CRS) 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: 2022-02-02
Enrollment: 196
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 with safety extension phase with crossover or continued treatment.

Detailed description: This is a 52-week, multicenter, phase III, randomized, blinded, controlled, parallel group with a 24-week treatment period followed by a safety extension phase with crossover or continued treatment 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
* Undergone at least 2 trials of medical treatments in the past
* Mean 3 cardinal symptom (3CS) score
* Bilateral ethmoid disease confirmed on CT
* Has been informed of the nature of the study and provided written informed consent
* Agrees to comply with all study requirements
* If on a waiting list for sinonasal surgery, willing to be removed from list or have surgery date cancelled for the duration of the study.

Exclusion Criteria:

* Inability to tolerate topical anesthesia or endoscopic procedure
* 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) in Participants Without Nasal Polyps.
timeFrame: 24 Weeks
Secondary outcomes:
measure: CFBL in the 7-day Average Composite Score of 3CS in All Participants 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 3-D Volumetric CT Score at Week 20
timeFrame: Week 20
measure: Participants With Rescue Treatments for CRS Through Week 24
timeFrame: Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Lyra Investigational Site
state: Alabama
city: Escondido
country: United States
facility: Lyra Investigational Site
state: California
city: La Mesa
country: United States
facility: Lyra Investigational Site
state: California
city: Sacramento
country: United States
facility: Lyra Investigational Site
state: California
city: Torrance
country: United States
facility: Lyra Investigational Site
state: California
city: Boca Raton
country: United States
facility: Lyra Investigational Site
state: Florida
city: Boynton Beach
country: United States
facility: Lyra Investigational Site
state: Florida
city: Plantation
country: United States
facility: Lyra Investigational Site
state: Florida
city: Port Saint Lucie
country: United States
facility: Lyra Investigational Site
state: Florida
city: Chicago
country: United States
facility: Lyra Investigational Site
state: Illinois
city: Louisville
country: United States
facility: Lyra Investigational Site
state: Kentucky
city: Baltimore
country: United States
facility: Lyra Investigational Site
state: Maryland
city: New Hyde Park
country: United States
facility: Lyra Investigational Site
state: New York
city: New York
country: United States
facility: Lyra Investigational Site
state: New York
city: New York
country: United States
facility: Lyra Investigational Site
state: New York
city: New York
country: United States
facility: Lyra Investigational Site
state: New York
city: Winston-Salem
country: United States
facility: Lyra Investigational Site
state: North Carolina
city: Charleston
country: United States
facility: Lyra Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: Lyra Investigational Site
state: South Carolina
city: Nashville
country: United States
facility: Lyra Investigational Site
state: Tennessee
city: Fort Worth
country: United States
facility: Lyra Investigational Site
state: Texas
city: Houston
country: United States
facility: Lyra Investigational Site
state: Texas
city: Mansfield
country: United States
facility: Lyra Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Lyra Investigational Site
state: Texas
city: South Ogden
country: United States
facility: Lyra Investigational Site
state: Utah
city: Norfolk
country: United States
facility: Lyra Investigational Site
state: Virginia
city: Graz
country: Austria
facility: Lyra Investigational Site
city: Klagenfurt am Worthersee
country: Austria
facility: Lyra Investigational Site
city: Linz
country: Austria
facility: Lyra Investigational Site
city: Wien
country: Austria
facility: Lyra Investigational Site
city: Brno
country: Czechia
facility: Lyra Investigational Site
city: Hradec Králové
country: Czechia
facility: Lyra Investigational Site
city: Motol
country: Czechia
facility: Lyra Investigational Site
city: Olomouc
country: Czechia
facility: Lyra Investigational Site
city: Praha
country: Czechia
facility: Lyra Investigational Site
city: Bydgoszcz
country: Poland
facility: Lyra Investigational Site
city: Bydgoszcz
country: Poland
facility: Lyra Investigational Site
city: Elbląg
country: Poland
facility: Lyra Investigational Site
city: Katowice
country: Poland
facility: Lyra Investigational Site
city: Kraków
country: Poland
facility: Lyra Investigational Site
city: Kraków
country: Poland
facility: Lyra Investigational Site
city: Krosno
country: Poland
facility: Lyra Investigational Site
city: Lublin
country: Poland
facility: Lyra Investigational Site
city: Nadarzyn
country: Poland
facility: Lyra Investigational Site
city: Warszawa
country: Poland
facility: Lyra Investigational Site
city: Warszawa
country: Poland
facility: Lyra Investigational Site
city: Wrocław
country: Poland
facility: Lyra Investigational Site
city: Barcelona
country: Spain
facility: Lyra Investigational Site
city: Barcelona
country: Spain
facility: Lyra Investigational Site
city: Bilbao
country: Spain
facility: Lyra Investigational Site
city: Cadiz
country: Spain
facility: Lyra Investigational Site
city: Granada
country: Spain
facility: Lyra Investigational Site
city: Madrid
country: Spain
facility: Lyra Investigational Site
city: Navarro
country: Spain
facility: Lyra Investigational Site
city: Santander
country: Spain
facility: Lyra Investigational Site
Study officials:
References: