Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 2)

• Status: Not yet recruiting
• Trial end date: 2024-01-15
• Target enrollment: 0
• Participant gender: All

Summary

Multicenter, phase III, randomized, blinded, controlled, parallel group.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lyra Therapeutics

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

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