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

Chronic Sinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05295459
• Other study ID #: LYR-210-2021-005
• Status: Recruiting
• Phase: Phase 3
• Start date: May 13, 2022
• Est. completion date: December 15, 2024

Study information

• Verified date: March 2024
• Source: Lyra Therapeutics
• Contact: Lyra Clinical
• Phone: 617-393-4600
• Email: lyraclinical[@]lyratx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 15, 2024
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis (Diagnosis)
• Chronic Sinusitis
• Rhinosinusitis
• Sinusitis

Intervention

Drug:
• LYR-210
LYR-210 drug matrix (mometasone furoate)
• Sham procedure control
Sham procedure control

Other:
• Background therapy
Daily Saline Irrigation

Locations

Country	Name	City	State
Belgium	Lyra Investigational Site	Brussels
Belgium	Lyra Investigation Site	Gent
Belgium	Lyra Investigational Site	Leuven
Bulgaria	Lyra Investigational Site	Burgas
Bulgaria	Lyra Investigational Site	Pleven
Bulgaria	Lyra Investigational Site	Plovdiv
Bulgaria	Lyra Investigational Site	Sofia
Bulgaria	Lyra Investigational Site	Varna
Germany	Lyra Investigational Site	Baden
Germany	Lyra Investigational Site	Berlin
Germany	Lyra Investigational Site	Dresden
Germany	Lyra Investigational Site	Goettigen
Germany	Lyra Investigational Site	Landsberg
Germany	Lyra Investigational Site	Tuebingen
Hungary	Lyra Investigational Site	Budapest
Hungary	Lyra Investigational Site	Budapest
Hungary	Lyra Investigational Site	Budapest
Hungary	Lyra Investigational Site	Budapest
Hungary	Lyra Investigational Site	Budapest
Hungary	Lyra Investigational Site	Nyíregyháza
Hungary	Lyra Investigational Site	Pécs
Hungary	Lyra Investigational Site	Tatabánya
Poland	Lyra Investigational Site	Bialystok
Poland	Lyra Investigational Site	Inowroclaw
Poland	Lyra Investigational Site	Krakow
Poland	Lyra Investigational Site	Lublin
Poland	Lyra Investigational Site	Warszawa
Poland	Lyra Investigational Site	Warszawa
Poland	Lyra Investigational Site	Wroclaw
United States	Lyra Investigational Site	Albany	New York
United States	Lyra Investigational Site	Arcadia	California
United States	Lyra Investigational Site	Boca Raton	Florida
United States	Lyra Investigational Site	Boston	Massachusetts
United States	Lyra Investigational Site	Boston	Massachusetts
United States	Lyra Investigational Site	Boynton Beach	Florida
United States	Lyra Investigational Site	Brandon	Florida
United States	Lyra Investigational Site	Carlsbad	California
United States	Lyra Investigational Site	Chicago	Illinois
United States	Lyra Investigational Site	Chicago	Illinois
United States	Lyra Investigational Site	Cincinnati	Ohio
United States	Lyra Investigational Site	Cleveland	Ohio
United States	Lyra Investigational Site	Colorado Springs	Colorado
United States	Lyra Investigational Site	Columbia	Missouri
United States	Lyra Investigational Site	Fairway	Kansas
United States	Lyra Investigational Site	Frisco	Texas
United States	Lyra Investigational Site	Houston	Texas
United States	Lyra Investigational Site	Indianapolis	Indiana
United States	Lyra Investigational Site	Lebanon	New Hampshire
United States	Lyra Investigational Site	Los Angeles	California
United States	Lyra Investigational Site	Los Angeles	California
United States	Lyra Investigational Site	Marrero	Louisiana
United States	Lyra Investigational Site	McKinney	Texas
United States	Lyra Investigational Site	New Haven	Connecticut
United States	Lyra Investigational Site	New York	New York
United States	Lyra Investigational Site	New York	New York
United States	Lyra Investigational Site	Ogden	Utah
United States	Lyra Investigational Site	Orange	California
United States	Lyra Investigational Site	Orangeburg	South Carolina
United States	Lyra Investigational Site	Plantation	Florida
United States	Lyra Investigational Site	Plantation	Florida
United States	Lyra Investigational Site	Port Saint Lucie	Florida
United States	Lyra Investigational Site	Richmond	Virginia
United States	Lyra Investigational Site	Rochester	New York
United States	Lyra Investigational Site	Roseville	California
United States	Lyra Investigational Site	Sacramento	California
United States	Lyra Investigational Site	Saint Louis	Missouri
United States	Lyra Investigational Site	San Diego	California
United States	Lyra Investigational Site	Torrance	California
United States	Lyra Investigational Site	Tucson	Arizona
United States	Lyra Investigational Site	Wesley Chapel	Florida
United States	Lyra Investigational Site	White Plains	New York
United States	Lyra Investigational Site	Wilkes-Barre	Pennsylvania
United States	Lyra Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Lyra Therapeutics

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Germany,  Hungary,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline (CFBL) in the 7-day average composite score of 3 cardinal symptoms (3CS) in participants without nasal polyps.	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.	24 Weeks
Secondary	CFBL in the 7-day average composite score of 3CS at 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.	24 Weeks
Secondary	CFBL in the 7-day average CS score of nasal blockage/obstruction/congestion at Week 24.	Nasal blockage/obstruction/congestion is one of the 3 cardinal symptoms. Each symptom is rated on a 4-point (0-3) scale where 0=absent symptoms and 3=severe symptoms.	24 Weeks
Secondary	CFBL in the 7-day average CS score of anterior/posterior nasal discharge at Week 24.	Anterior/posterior nasal discharge is one of the 3 cardinal symptoms. Each symptom is rated on a 4-point (0-3) scale where 0=absent symptoms and 3=severe symptoms.	24 Weeks
Secondary	CFBL in the 7-day average CS score of facial pain/pressure at Week 24.	Facial pain/pressure is one of the 3 cardinal symptoms. Each symptom is rated on a 4-point (0-3) scale where 0=absent symptoms and 3=severe symptoms.	24 Weeks
Secondary	CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) total score at 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.	24 Weeks
Secondary	CFBL in the 3-D volumetric CT score at Week 20.		20 Weeks
Secondary	Number and percent of participants requiring rescue treatment through Week 24		24 Weeks