Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05035654




Registration number
NCT05035654
Ethics application status
Date submitted
27/08/2021
Date registered
5/09/2021
Date last updated
21/09/2023

Titles & IDs
Public title
LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study)
Scientific 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
Secondary ID [1] 0 0
LYR-220-2021-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Sinusitis 0 0
Chronic Rhinosinusitis (Diagnosis) 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LYR-220 Design 1
Treatment: Drugs - LYR-220 Design 2
Treatment: Drugs - Bilateral sham procedure control

Experimental: Treatment Arm A: LYR-220 Design 1 - Bilateral insertion of 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

Sham Comparator: Treatment Arm C: Bilateral sham procedure control - Bilateral sham procedure control


Treatment: Drugs: LYR-220 Design 1
LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1

Treatment: Drugs: LYR-220 Design 2
LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2

Treatment: Drugs: Bilateral sham procedure control
Bilateral sham procedure control
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Product-related unexpected serious adverse events
Timepoint [1] 0 0
Through Week 28
Primary outcome [2] 0 0
Plasma MF concentrations
Timepoint [2] 0 0
Through Week 25
Secondary outcome [1] 0 0
Adverse Events
Timepoint [1] 0 0
Through Week 28
Secondary outcome [2] 0 0
Laboratory Values (hematology and chemistry)
Timepoint [2] 0 0
Through Week 25
Secondary outcome [3] 0 0
Endoscopic findings
Timepoint [3] 0 0
Through Week 25
Secondary outcome [4] 0 0
Ophthalmic Assessment: Intraocular Pressure (IOP)
Timepoint [4] 0 0
Through Week 25
Secondary outcome [5] 0 0
Ophthalmic Assessment: Cataract
Timepoint [5] 0 0
Through Week 25
Secondary outcome [6] 0 0
Improving Chronic Rhinosinusitis (CRS) specific Quality of Life as per the 22-item sino-nasal outcome test (SNOT-22) questionnaire
Timepoint [6] 0 0
Through Week 28
Secondary outcome [7] 0 0
Change in Chronic Rhinosinusitis (CRS) symptom scores
Timepoint [7] 0 0
Through Week 28

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/08/2023
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Lyra Investigational Site - Bedford Park
Recruitment hospital [2] 0 0
Lyra Investigational Site - Brisbane
Recruitment hospital [3] 0 0
Lyra Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Utah
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Lyra Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05035654
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries