Chronic SinusitisPhase 2NCT05035654
LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study)
A Phase 2 study testing LYR-220 Design 1 (Part 1 only) and LYR-220 Design 2 (Part 1 and Part 2) in people with Chronic Sinusitis and Chronic Rhinosinusitis (Diagnosis), run by Lyra Therapeutics at 25 sites in 2 countries.
Trial summary
This study will assess the safety, tolerability, pharmacokinetics and efficacy of two LYR-220 designs in symptomatic adult chronic rhinosinusitis (CRS) subjects who have had a prior functional endoscopic sinus surgery. 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-220 Design 1 (Part 1 only) and LYR-220 Design 2 (Part 1 and Part 2)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 25 sitesin 2 countries
- Study dates
- 23 Nov 2021to 30 Aug 2023
- Phase
- Phase 2
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
- Diagnosis of chronic rhinosinusitis.
- Has had a prior bilateral total ethmoidectomy.
- Has computed tomography (CT) ethmoid cavity opacification.
- Has a Sinonasal Outcome Test (SNOT-22) ≥ 20 at Screening Visit.
- Minimum cardinal symptom score.
- Has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site or regulatory authority if applicable by national law.
- Agrees to comply with all study requirements.
Who cannot join
- Pregnant or breast feeding.
- Known history of hypersensitivity or intolerance to corticosteroids.
- History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, or atrophic rhinitis.
- Known history of hypothalamic pituitary adrenal axial dysfunction.
- Had dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
- Past or present functional vision in only one eye.
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- Past, present, or planned organ transplant or chemotherapy with immunosuppression.
- With prior cataract surgery or presence (in either eye) of posterior subcapsular cataract of grade 2 or higher, nuclear cataract of grade 3 or higher, or cortical cataract of grade 2 or higher or involving a minimum of center optic zone of 3 mm diameter.
- Ethmoidectomy that was unilateral or partial.
- Currently participating in an investigational drug or device study.
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United States22 sites
Lyra Investigational Site
Baltimore, Maryland, 21204
Lyra Investigational Site
Bethlehem, Pennsylvania, 18017
Lyra Investigational Site
Carlsbad, California, 92008
Lyra Investigational Site
Chapel Hill, North Carolina, 27599
Lyra Investigational Site
Chicago, Illinois, 60208
Lyra Investigational Site
Chicago, Illinois, 60657
Lyra Investigational Site
Fort Worth, Texas, 76109
Lyra Investigational Site
La Mesa, California, 91942
Lyra Investigational Site
Louisville, Kentucky, 40205
Lyra Investigational Site
Marrero, Louisiana, 70072
Lyra Investigational Site
McKinney, Texas, 75069
Lyra Investigational Site
New Albany, Indiana, 47150
Lyra Investigational Site
New Hyde Park, New York, 11042
Lyra Investigational Site
New York, New York, 10016
Lyra Investigational Site
Orangeburg, South Carolina, 29118
Lyra Investigational Site
Roseville, 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
Spokane, Washington, 99201
Lyra Investigational Site
Torrance, California, 90501
Lyra Investigational Site
Winston-Salem, North Carolina, 27103
Australia3 sites
Lyra Investigational Site
Bedford Park, 5042
Lyra Investigational Site
Brisbane
Lyra Investigational Site
Melbourne
About this study
Official title: BEACON: A Phase II, Patient-blinded, Two-part, Randomized, Parallel-group Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of LYR-220 in Chronic Rhinosinusitis (CRS) Patients Who Have Had a Prior Ethmoidectomy
This study will assess the safety, tolerability, pharmacokinetics and efficacy of two LYR-220 designs in symptomatic adult chronic rhinosinusitis (CRS) subjects who have had a prior functional endoscopic sinus surgery.
Read the detailed description
This is a Phase II, Patient-blinded, Two-part, Randomized, Parallel-group Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of LYR-220. The study will consist of two parts: Part 1 will enroll up to 10 patients and is open label. Part 2 is randomized, sham controlled and will enroll approximately 40 patients. The study follow-up duration is 28 weeks.
- Being tested
- LYR-220 Design 1 (Part 1 only), LYR-220 Design 2 (Part 1 and Part 2), Bilateral sham procedure control (Part 2)
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LYR-220 Design 1 (Part 1 only)Drug
LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1
LYR-220 Design 2 (Part 1 and Part 2)Drug
LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2
Bilateral sham procedure control (Part 2)Drug
Bilateral sham procedure control
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Treatment Arm LYR-220 Design 1 | Experimental | Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1 Receives: Drug: LYR-220 Design 1 (Part 1 only) |
| Part 1 and Part 2: Treatment Arm LYR-220 Design 2 | Experimental | Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2 Receives: Drug: LYR-220 Design 2 (Part 1 and Part 2) |
| Part 2: Treatment Arm Bilateral sham procedure control | Sham comparator | Bilateral sham procedure control Receives: Drug: Bilateral sham procedure control (Part 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Product-related Unexpected Serious Adverse Events
Product-related unexpected serious adverse events
Measured: Through Week 28
Plasma MF Concentrations
Plasma MF concentrations at 1 hour post study treatment administration and at Days 2 or 3, days 5 or 8, and Weeks 4,12,16 or 20, 24 and 25.
The PK analysis will be performed based on subjects with available plasma MF concentration data post Day 1 administration procedure.
Measured: Through Week 25
Secondary outcomes (6)
Adverse Events
Percentage of subjects reporting treatment-emergent adverse events
Measured: Through Week 28
Endoscopic Findings
Percentage of subjects with newly identified or worsened endoscopic findings in the ethmoid cavity (mild, moderate, or severe)
Measured: Through Week 25
Ophthalmic Assessment: Intraocular Pressure (IOP)
Percentage of subjects with clinically significant increase in IOP
Measured: Through Week 25
Ophthalmic Assessment: Cataract
Percentage of subjects with newly identified or worsened cataract in one or both eyes
Measured: Through Week 25
Improving Chronic Rhinosinusitis (CRS) Specific Quality of Life as Per the 22-item Sino-nasal Outcome Test (SNOT-22) Questionnaire
The 22-item Sino-Nasal Outcome Test (SNOT-22) questionnaire is a 22-item disease-specific quality of life instrument validated for use in CRS. Each symptom is scored as it has been over the past 2 weeks on a 6-point scale as follows: 0 = no problem, 1 = very mild problem, 2 = mild or slight problem, 3 = moderate problem, 4 = severe problem, 5 = problem as bad as it can be.
The outcome measure is change from baseline in total patient-reported outcome score. The SNOT-22 total score is the sum of individual scores and ranges from 0 to 110. Higher scores indicate higher severity of symptoms.
Measured: Through Week 28
Change From Baseline in the Average Composite Score Over the Preceeding 7 Days of the 3 Cardinal Symptoms (3CS)
Change from baseline in the average composite score over the preceeding 7 days of the 3 Cardinal Symptoms (3CS).The 3CS include: nasal blockage/obstruction/congestion, facial pain/ pressure, and anterior/posterior nasal discharge. The diary is completed daily by study participants throughout the study. Each symptom/each question is scored daily on a 0-3 scale as follows: 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The 3CS total score ranges from 0-9, with higher scores indicating worse symptoms.
Measured: Through Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start23 Nov 2021
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 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
- NCT05035654
- Sponsor's protocol ID
- LYR-220-2021-001
- Status last verified
- Nov 2024
- First submitted
- 27 Aug 2021
- Last updated
- 17 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No