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

Lyra Therapeutics

Status and phase: Completed; Phase 3

Conditions: Chronic Sinusitis; Chronic Rhinosinusitis (Diagnosis)

Treatments: Drug: LYR-210; Drug: Sham procedure control; Other: Background therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT05295459

LYR-210-2021-005

Details and patient eligibility

About

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

Full 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.

Enrollment: 182 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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182 participants in 2 patient groups

LYR-210

Experimental group

Description:

Single administration of LYR-210 drug matrix (7500 μg)

Treatment:

Other: Background therapy

Drug: LYR-210

Sham procedure control

Sham Comparator group

Description:

Single mock administration procedure

Treatment:

Other: Background therapy

Drug: Sham procedure control