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Trial record 1 of 1 for:    lyr-220-2021
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LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study)

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ClinicalTrials.gov Identifier: NCT05035654
Recruitment Status : Active, not recruiting
First Posted : September 5, 2021
Last Update Posted : February 24, 2023
Sponsor:
Information provided by (Responsible Party):
Lyra Therapeutics

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Sinusitis Chronic Rhinosinusitis (Diagnosis) Drug: LYR-220 Design 1 Drug: LYR-220 Design 2 Drug: Bilateral sham procedure control Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : November 23, 2021
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Arm A: LYR-220 Design 1
Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1
 Drug: LYR-220 Design 1
LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1
Experimental: Treatment Arm B: LYR-220 Design 2
Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2
 Drug: LYR-220 Design 2
LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2
Sham Comparator: Treatment Arm C: Bilateral sham procedure control
Bilateral sham procedure control
 Drug: Bilateral sham procedure control
Bilateral sham procedure control


Outcome Measures
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Primary Outcome Measures :
  1. Product-related unexpected serious adverse events [ Time Frame: Through Week 28 ]
    Product-related unexpected serious adverse events

  2. Plasma MF concentrations [ Time Frame: Through Week 25 ]
    Plasma MF concentrations


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Through Week 28 ]
    Severity and percentage of subjects reporting treatment-emergent adverse events and serious adverse events

  2. Laboratory Values (hematology and chemistry) [ Time Frame: Through Week 25 ]
    Percentage of subjects with abnormal and clinically significant abnormal laboratory values

  3. Endoscopic findings [ Time Frame: Through Week 25 ]
    Percentage of subjects with newly identified or worsened endoscopic findings in the ethmoid cavity (mild, moderate, or severe)

  4. Ophthalmic Assessment: Intraocular Pressure (IOP) [ Time Frame: Through Week 25 ]
    Percentage of subjects with clinically significant increase in IOP

  5. Ophthalmic Assessment: Cataract [ Time Frame: Through Week 25 ]
    Percentage of subjects with newly identified or worsened cataract in one or both eyes

  6. Improving Chronic Rhinosinusitis (CRS) specific Quality of Life as per the 22-item sino-nasal outcome test (SNOT-22) questionnaire [ Time Frame: Through Week 28 ]
    Change from baseline in total patient-reported outcome measures. Each symptom is scored as it has been over the past two weeks on a 6-point scale (0 to 5: 0 = no problem to 5 = problem as bad as it can be). Higher scores indicate severity of symptoms.

  7. Change in Chronic Rhinosinusitis (CRS) symptom scores [ Time Frame: Through Week 28 ]
    Change from baseline in the average composite score


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05035654


Locations
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United States, California
Lyra Investigational Site
Carlsbad, California, United States, 92008
Lyra Investigational Site
La Mesa, California, United States, 91942
Lyra Investigational Site
Roseville, California, United States, 95661
Lyra Investigational Site
Torrance, California, United States, 90501
United States, Illinois
Lyra Investigational Site
Chicago, Illinois, United States, 60208
Lyra Investigational Site
Chicago, Illinois, United States, 60657
United States, Indiana
Lyra Investigational Site
New Albany, Indiana, United States, 47150
United States, Kentucky
Lyra Investigational Site
Louisville, Kentucky, United States, 40205
United States, Louisiana
Lyra Investigational Site
Marrero, Louisiana, United States, 70072
United States, Maryland
Lyra Investigational Site
Baltimore, Maryland, United States, 21204
United States, New York
Lyra Investigational Site
New Hyde Park, New York, United States, 11042
Lyra Investigational Site
New York, New York, United States, 10016
United States, North Carolina
Lyra Investigational Site
Chapel Hill, North Carolina, United States, 27599
Lyra Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Lyra Investigational Site
Bethlehem, Pennsylvania, United States, 18017
United States, South Carolina
Lyra Investigational Site
Orangeburg, South Carolina, United States, 29118
Lyra Investigational Site
Spartanburg, South Carolina, United States, 29303
United States, Texas
Lyra Investigational Site
Fort Worth, Texas, United States, 76109
Lyra Investigational Site
McKinney, Texas, United States, 75069
Lyra Investigational Site
San Antonio, Texas, United States, 78258
United States, Utah
Lyra Investigational Site
South Ogden, Utah, United States, 84405
United States, Washington
Lyra Investigational Site
Spokane, Washington, United States, 99201
Australia
Lyra Investigational Site
Bedford Park, Australia, 5042
Lyra Investigational Site
Brisbane, Australia
Lyra Investigational Site
Melbourne, Australia
Sponsors and Collaborators
Lyra Therapeutics
More Information
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Responsible Party: Lyra Therapeutics
ClinicalTrials.gov Identifier: NCT05035654    
Other Study ID Numbers: LYR-220-2021-001
First Posted: September 5, 2021    Key Record Dates
Last Update Posted: February 24, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Sinusitis
Respiratory Tract Infections
Infections
Paranasal Sinus Diseases
 Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases