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

Primary Purpose

Chronic Sinusitis, Chronic Rhinosinusitis (Diagnosis)

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
LYR-210
Sham procedure control
Background therapy
Sponsored by
Lyra Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Sinusitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lyra Investigational SiteRecruiting
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  • Lyra Investigation SiteRecruiting
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  • Lyra Investigational SiteRecruiting
  • Lyra Investigational SiteRecruiting
  • Lyra Investigational SiteRecruiting
  • Lyra Investigational SiteRecruiting
  • Lyra Investigational SiteRecruiting
  • Lyra Investigational Site
  • Lyra Investigational Site
  • Lyra Investigational SiteRecruiting
  • Lyra Investigational SiteRecruiting
  • Lyra Investigational SiteRecruiting
  • Lyra Investigational SiteRecruiting
  • Lyra Investigational Site
  • Lyra Investigational Site
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  • Lyra Investigational Site
  • Lyra Investigational Site
  • Lyra Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

LYR-210

Sham procedure control

Arm Description

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

Single mock administration procedure

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
CFBL in the 3-D volumetric CT score at Week 20.
Number and percent of participants requiring rescue treatment through Week 24

Full Information

First Posted
March 8, 2022
Last Updated
October 13, 2023
Sponsor
Lyra Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05295459
Brief Title
Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 2)
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 13, 2022 (Actual)
Primary Completion Date
January 15, 2024 (Anticipated)
Study Completion Date
January 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lyra Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Multicenter, phase III, randomized, blinded, controlled, parallel group.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis, Chronic Rhinosinusitis (Diagnosis)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LYR-210
Arm Type
Experimental
Arm Description
Single administration of LYR-210 drug matrix (7500 μg)
Arm Title
Sham procedure control
Arm Type
Sham Comparator
Arm Description
Single mock administration procedure
Intervention Type
Drug
Intervention Name(s)
LYR-210
Intervention Description
LYR-210 drug matrix (mometasone furoate)
Intervention Type
Drug
Intervention Name(s)
Sham procedure control
Intervention Description
Sham procedure control
Intervention Type
Other
Intervention Name(s)
Background therapy
Intervention Description
Daily Saline Irrigation
Primary Outcome Measure Information:
Title
Change from baseline (CFBL) in the 7-day average composite score of 3 cardinal symptoms (3CS) in participants without nasal polyps.
Description
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.
Time Frame
24 Weeks
Secondary Outcome Measure Information:
Title
CFBL in the 7-day average composite score of 3CS at Week 24.
Description
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.
Time Frame
24 Weeks
Title
CFBL in the 7-day average CS score of nasal blockage/obstruction/congestion at Week 24.
Description
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.
Time Frame
24 Weeks
Title
CFBL in the 7-day average CS score of anterior/posterior nasal discharge at Week 24.
Description
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.
Time Frame
24 Weeks
Title
CFBL in the 7-day average CS score of facial pain/pressure at Week 24.
Description
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.
Time Frame
24 Weeks
Title
CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) total score at Week 24.
Description
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.
Time Frame
24 Weeks
Title
CFBL in the 3-D volumetric CT score at Week 20.
Time Frame
20 Weeks
Title
Number and percent of participants requiring rescue treatment through Week 24
Time Frame
24 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lyra Clinical
Phone
617-393-4600
Email
lyraclinical@lyratx.com
Facility Information:
Facility Name
Lyra Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Carlsbad
State/Province
California
ZIP/Postal Code
92008
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90006
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Lyra Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Lyra Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Lake Mary
State/Province
Florida
ZIP/Postal Code
32746
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Lyra Investigational Site
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Wesley Chapel
State/Province
Florida
ZIP/Postal Code
33544
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Lyra Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Lyra Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Lyra Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
McKinney
State/Province
Texas
ZIP/Postal Code
75070
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Lyra Investigational Site
City
Saint George
State/Province
Utah
ZIP/Postal Code
84970
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Brussels
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Lyra Investigation Site
City
Gent
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Leuven
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Burgas
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Pleven
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Plovdiv
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Varna
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Baden
ZIP/Postal Code
76669
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lyra I Site
Facility Name
Lyra Investigational Site
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Dresden
Country
Germany
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Goettigen
Country
Germany
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Landsberg
Country
Germany
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Tuebingen
Country
Germany
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Lyra Investigational Site
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Lyra Investigational Site
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Nyíregyháza
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Pécs
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Tatabánya
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Lyra Investigational Site
City
Białystok
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Lyra Investigational Site
City
Inowrocław
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Lyra Investigational Site
City
Krakow
ZIP/Postal Code
31-411
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Lyra Investigational Site
City
Lublin
ZIP/Postal Code
20-362
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Lyra Investigational Site
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Lyra Investigational Site
City
Warszawa
ZIP/Postal Code
03-242
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Lyra Investigational Site
City
Wrocław
ZIP/Postal Code
53-149
Country
Poland
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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