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

Chronic Sinusitis Clinical Trial

— ENLIGHTEN 1  

Official title:

ENLIGHTEN 1: A Phase III, Randomized, Blinded, Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis (CRS) in Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05219968
• Other study ID #: LYR-210-2021-004
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 27, 2022
• Est. completion date: September 15, 2024

Study information

• Verified date: September 2023
• Source: Lyra Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Multicenter, phase III, randomized, blinded, controlled, parallel group with safety extension phase with crossover or continued treatment.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 196
• Est. completion date: September 15, 2024
• Est. primary completion date: March 4, 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

• 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.

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

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
Austria	Lyra Investigational Site	Graz
Austria	Lyra Investigational Site	Klagenfurt am Worthersee
Austria	Lyra Investigational Site	Linz
Austria	Lyra Investigational Site	Wien
Czechia	Lyra Investigational Site	Brno
Czechia	Lyra Investigational Site	Hradec Králové
Czechia	Lyra Investigational Site	Motol
Czechia	Lyra Investigational Site	Olomouc
Czechia	Lyra Investigational Site	Praha
Poland	Lyra Investigational Site	Bydgoszcz
Poland	Lyra Investigational Site	Bydgoszcz
Poland	Lyra Investigational Site	Elblag
Poland	Lyra Investigational Site	Katowice
Poland	Lyra Investigational Site	Kraków
Poland	Lyra Investigational Site	Kraków
Poland	Lyra Investigational Site	Krosno
Poland	Lyra Investigational Site	Lublin
Poland	Lyra Investigational Site	Nadarzyn
Poland	Lyra Investigational Site	Warszawa
Poland	Lyra Investigational Site	Warszawa
Poland	Lyra Investigational Site	Wroclaw
Spain	Lyra Investigational Site	Barcelona
Spain	Lyra Investigational Site	Barcelona
Spain	Lyra Investigational Site	Bilbao
Spain	Lyra Investigational Site	Cadiz
Spain	Lyra Investigational Site	Granada
Spain	Lyra Investigational Site	Madrid
Spain	Lyra Investigational Site	Navarro
Spain	Lyra Investigational Site	Santander
United States	Lyra Investigational Site	Baltimore	Maryland
United States	Lyra Investigational Site	Birmingham	Alabama
United States	Lyra Investigational Site	Boca Raton	Florida
United States	Lyra Investigational Site	Boynton Beach	Florida
United States	Lyra Investigational Site	Charleston	South Carolina
United States	Lyra Investigational Site	Chicago	Illinois
United States	Lyra Investigational Site	Escondido	California
United States	Lyra Investigational Site	Fort Worth	Texas
United States	Lyra Investigational Site	Houston	Texas
United States	Lyra Investigational Site	La Mesa	California
United States	Lyra Investigational Site	Louisville	Kentucky
United States	Lyra Investigational Site	Mansfield	Texas
United States	Lyra Investigational Site	Nashville	Tennessee
United States	Lyra Investigational Site	New Hyde Park	New York
United States	Lyra Investigational Site	New York	New York
United States	Lyra Investigational Site	New York	New York
United States	Lyra Investigational Site	New York	New York
United States	Lyra Investigational Site	Norfolk	Virginia
United States	Lyra Investigational Site	Plantation	Florida
United States	Lyra Investigational Site	Port Saint Lucie	Florida
United States	Lyra Investigational Site	Sacramento	California
United States	Lyra Investigational Site	San Antonio	Texas
United States	Lyra Investigational Site	South Ogden	Utah
United States	Lyra Investigational Site	Spartanburg	South Carolina
United States	Lyra Investigational Site	Torrance	California
United States	Lyra Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Lyra Therapeutics

Countries where clinical trial is conducted

United States,  Austria,  Czechia,  Poland,  Spain, 

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 in all participants 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.	Week 24
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.	Week 24
Secondary	CFBL in the 3-D volumetric CT score at 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.	Week 20
Secondary	Number and percent of participants requiring rescue treatment through Week 24	This endpoint will be descriptively summarized.	Week 24