Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults

Phase 3

Active, not recruiting

• Conditions: Chronic Sinusitis; Chronic Rhinosinusitis (Diagnosis)
• Interventions: Drug: LYR-210; Drug: Sham procedure control; Other: Background Therapy

• Registration Number: NCT05219968
• Lead Sponsor: Lyra Therapeutics

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.

Study Timeline

• Study First Submitted: 2022-01-21
• Study First Submitted QC: 2022-01-21
• Study Start: 2022-01-27
• Study First Posted: 2022-02-02
• Status Verified: 2023-09
• Primary Completion: 2024-03-04
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-06
• Study Completion: 2024-09-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 196

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LYR-210	LYR-210	Single administration of LYR-210 drug matrix (7500 μg)
LYR-210	Background Therapy	Single administration of LYR-210 drug matrix (7500 μg)
Sham procedure control	Sham procedure control	Single mock administration procedure
Sham procedure control	Background Therapy	Single mock administration procedure

Primary Outcome Measures

Name	Time	Method
Change from baseline (CFBL) in the 7-day average composite score of 3 cardinal symptoms (3CS) in participants without nasal polyps.	24 Weeks	The 3CS are nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. Each symptom is rated on a 4-point (0-3) scale where 0=absent symptoms and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores.

Secondary Outcome Measures

Name	Time	Method
CFBL in the 7-day average composite score of 3CS in all participants at Week 24.	Week 24	The 3CS are nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. Each symptom is rated on a 4-point (0-3) scale where 0=absent symptoms and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores.
CFBL in the 3-D volumetric CT score at Week 20	Week 20	The percent opacification of the bilateral anterior and posterior ethmoids will be assessed by 3-D volumetric CT analysis at baseline and Week 20.
CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) total score at Week 24	Week 24	The SNOT-22 questionnaire is a 22-item disease-specific quality of life instrument. Each symptom is scored on a 6-point scale where 0 = no problem and 5 = problem as bad as it can be. The total SNOT-22 score is the sum of the 22 items and can range from 0 to 110 with higher scores indicating worse symptoms.
Number and percent of participants requiring rescue treatment through Week 24	Week 24	This endpoint will be descriptively summarized.

Trial Locations

Locations (1)

Lyra Investigational Site; 🇪🇸 Santander, Spain