Status:
COMPLETED
Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 2)
Lead Sponsor:
Lyra Therapeutics
Conditions:
Chronic Sinusitis
Chronic Rhinosinusitis (Diagnosis)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2025
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT05295459
Start Date
May 13 2022
End Date
April 2 2025
Last Update
May 2 2025
Active Locations (57)
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1
Novak Clinical Trials
Tucson, Arizona, United States, 85741
2
Keck School of Medicine at USC Medical Center
Arcadia, California, United States, 91007
3
Sensa Health Clinical Research
Los Angeles, California, United States, 90006
4
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048