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
Status: Completed
Location: See all (57) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
Multicenter, phase III, randomized, blinded, controlled, parallel group.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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. \[Note: this does not preclude a participant from receiving or being recommended for sinonasal surgery as rescue treatment during the study\].
Locations
United States
Arizona
Novak Clinical Trials
Tucson
California
Keck School of Medicine at USC Medical Center
Arcadia
Cedars-Sinai Medical Center
Los Angeles
Sensa Health Clinical Research
Los Angeles
University of California - Irvine Medical Center
Orange
Sacramento Ear Nose and Throat Surgical and Medical Group, Inc
Roseville
University of California - Davis
Sacramento
Regional Head & Neck Consulting - SENTA Clinic
San Diego
Breathe Clear Institute
Torrance
Colorado
Colorado ENT and Allergy
Colorado Springs
Florida
Ear, Nose and Throat Associates of South Florida, P.A.
Boynton Beach
ENT and Allergy Associates of Florida - Brandon
Brandon
ENT and Allergy Associates of Florida - Plantation - Dr. Johnson
Plantation
ENT and Allergy Associates of Florida - Plantation - Dr. Wright
Plantation
ENT and Allergy Associates of Florida
Port Saint Lucie
Illinois
The University of Chicago Medical Center (UCMC)
Chicago
Indiana
Indiana University
Indianapolis
Kansas
University of Kansas Medical Center (KUMC)
Fairway
Louisiana
Tandem Clinical Research
Marrero
Massachusetts
Massachusetts Eye and Ear Infirmary
Boston
Missouri
University of Missouri-Columbia
Columbia
St Louis University
St Louis
New York
Columbia University
New York
ENT and Allergy Associates, LLP - Fifth Avenue New York
New York
University of Rochester
Rochester
ENT and Allergy Associates - White Plains
White Plains
South Carolina
Carolina Ear, Nose, & Throat Clinic/CENTRI, Inc.
Orangeburg
Texas
Houston Methodist Hospital
Houston
ENT Associates of Texas
Mckinney
Utah
Lyra Investigational Site
Ogden
Virginia
Lyra Investigational Site
Richmond
Other Locations
Belgium
University Hospital Gent
Ghent
Universitaire Ziekenhuizen Leuven
Leuven
Bulgaria
University Multiprofile Hospital for Active Treatment
Burgas
UMHAT Kaspela Ltd
Plovdiv
Military Medical Academy Multiprofile Hospital
Sofia
Diagnostic and Consulting Center Mladost - Varna
Varna
Germany
HNO Praxis Dr. Andrea Kienle-Gogolok
Baden
HNO Zentrum am Kudamm
Berlin
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden
HNO Landsberg
Landsberg
Universitaetsklinikum Tuebingen
Tübingen
Hungary
Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
Budapest
Budapesti Uzsoki Utcai Korhaz
Budapest
Eszak-Pesti Centrumkorhaz - Honvedkorhaz
Budapest
Semmelweis Egyetem - Nyaksebeszeti Klinika
Budapest
Szent Imre Korhaz
Budapest
Lyra Investigational Site
Nyíregyháza
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabánya
Poland
Sleepmedica
Bialystok
Farma-Med. Kujawskie Centrum Medyczne Sp. z o.o.
Inowrocław
Promed P.Lach R.Glowacki Spolka Jawna
Krakow
Velocity Lublin
Lublin
Lyra Investigational Site
Warsaw
Mazowiecki Szpital Brodnowski Sp. z o.o. - Zespol Oddzialow Otolaryngologii
Warsaw
Panstwowy Instytut Medyczny MSWiA - Klinika Otolaryngologii
Wroclaw
Time Frame
Start Date: 2022-05-13
Completion Date: 2025-04-02
Participants
Target number of participants: 182
Treatments
Experimental: LYR-210
Single administration of LYR-210 drug matrix (7500 μg)
Sham_comparator: Sham procedure control
Single mock administration procedure
Related Therapeutic Areas
Sponsors
Leads: Lyra Therapeutics