Chronic SinusitisPhase 3ENLIGHTEN 1NCT05219968
Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults
A Phase 3 study testing LYR-210 and Background Therapy in people with Chronic Sinusitis and Chronic Rhinosinusitis (Diagnosis), run by Lyra Therapeutics at 55 sites in 5 countries.
Trial summary
Multicenter, phase III, randomized, blinded, controlled, parallel group with safety extension phase with crossover or continued treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Sinusitis, Chronic Rhinosinusitis (Diagnosis)
- What is being tested?
- LYR-210 and Background Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- 55 sitesin 5 countries
- Study dates
- 27 Jan 2022to 16 Sep 2024
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
55 sites in 5 countries.
55 sites in 5 countries
United States26 sites
Lyra Investigational Site
Baltimore, Maryland, 21287
Lyra Investigational Site
Birmingham, Alabama, 35294-0012
Lyra Investigational Site
Boca Raton, Florida, 33487-5713
Lyra Investigational Site
Boynton Beach, Florida, 33426
Lyra Investigational Site
Charleston, South Carolina, 29425
Lyra Investigational Site
Chicago, Illinois, 60657
Lyra Investigational Site
Escondido, California, 92025
Lyra Investigational Site
Fort Worth, Texas, 76109
Lyra Investigational Site
Houston, Texas, 77030
Lyra Investigational Site
La Mesa, California, 91942
Lyra Investigational Site
Louisville, Kentucky, 40220
Lyra Investigational Site
Mansfield, Texas, 76063
Lyra Investigational Site
Nashville, Tennessee, 37232-8605
Lyra Investigational Site
New Hyde Park, New York, 11042
Lyra Investigational Site
New York, New York, 10003
Lyra Investigational Site
New York, New York, 10016
Lyra Investigational Site
New York, New York, 10029
Lyra Investigational Site
Norfolk, Virginia, 23507
Lyra Investigational Site
Plantation, Florida, 33324
Lyra Investigational Site
Port Saint Lucie, Florida, 34952
Lyra Investigational Site
Sacramento, California, 95661
Lyra Investigational Site
San Antonio, Texas, 78258
Lyra Investigational Site
South Ogden, Utah, 84405
Lyra Investigational Site
Spartanburg, South Carolina, 29303
Lyra Investigational Site
Torrance, California, 90503
Lyra Investigational Site
Winston-Salem, North Carolina, 27103
Poland12 sites
Lyra Investigational Site
Bydgoszcz, 85-047
Lyra Investigational Site
Bydgoszcz, 85-605
Lyra Investigational Site
Elblag, 82-300
Lyra Investigational Site
Katowice, 40-611
Lyra Investigational Site
Krakow, 30-033
Lyra Investigational Site
Krakow, 31-411
Lyra Investigational Site
Krosno, 38-400
Lyra Investigational Site
Lublin, 20-362
Lyra Investigational Site
Nadarzyn, 05-830
Lyra Investigational Site
Warsaw, 00-635
Lyra Investigational Site
Warsaw, 04-141
Lyra Investigational Site
Wroclaw, 53-149
Spain8 sites
Lyra Investigational Site
Barcelona, 08003
Lyra Investigational Site
Barcelona, 08022
Lyra Investigational Site
Bilbao, 48013
Lyra Investigational Site
Cadiz, 11407
Lyra Investigational Site
Granada, 18014
Lyra Investigational Site
Madrid, 28034
Lyra Investigational Site
Navarro, 31008
Lyra Investigational Site
Santander, 39008
Czechia5 sites
Lyra Investigational Site
Brno, 656 91
Lyra Investigational Site
Hradec Králové, 500 05
Lyra Investigational Site
Motol, 150 06
Lyra Investigational Site
Olomouc, 77900
Lyra Investigational Site
Prague, 140 59
Austria4 sites
Lyra Investigational Site
Graz, A-8036
Lyra Investigational Site
Klagenfurt, 9020
Lyra Investigational Site
Linz, 4010
Lyra Investigational Site
Vienna, 1090
About this study
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
Multicenter, phase III, randomized, blinded, controlled, parallel group with safety extension phase with crossover or continued treatment.
Read the 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.
- Being tested
- LYR-210, Sham procedure control, Background Therapy
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LYR-210Drug
LYR-210 drug matrix (mometasone furoate)
Sham procedure controlDrug
Sham procedure control
Background TherapyOther
Daily Saline Irrigation
| Study group | Role | What they receive |
|---|---|---|
| LYR-210 | Experimental | Single administration of LYR-210 drug matrix (7500 μg) Receives: Drug: LYR-210; Other: Background Therapy |
| Sham procedure control | Sham comparator | Single mock administration procedure Receives: Drug: Sham procedure control; Other: Background Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. The diary is completed daily by study participants throughout the study. Each symptom/each question is rated on a 4-point (0-3) scale where 0= none/absent symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores.
The 3CS total score ranges from 0-9, with higher scores indicating worse symptoms.
Measured: 24 Weeks
Secondary outcomes (4)
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. The diary is completed daily by study participants throughout the study. Each symptom/each question is rated on a 4-point (0-3) scale where 0= none/absent symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores.
The 3CS total score ranges from 0-9, with higher scores indicating worse symptoms.
Measured: Week 24
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.
Measured: Week 24
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.
A negative change from Baseline indicates improvement from Baseline.
Measured: Week 20
Participants With Rescue Treatments for CRS Through Week 24
This endpoint is descriptively summarized per the prespecified plan. This includes participants that used systemic corticosteroid for any reason as well as participants that were recommended/underwent sinonasal surgery.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start27 Jan 2022
- Primary completion4 Mar 2024
- Study completion16 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lyra Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219968
- Sponsor's protocol ID
- LYR-210-2021-004
- Acronym
- ENLIGHTEN 1
- Status last verified
- Apr 2025
- First submitted
- 21 Jan 2022
- Last updated
- 2 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No