CLINICAL TRIAL / NCT05295459
Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 2)
- Interventional
- Recruiting
- NCT05295459
Contact Information
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
Multicenter, phase III, randomized, blinded, controlled, parallel group.
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.
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
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