Trial Review

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Trial details imported from ClinicalTrials.gov

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

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

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)

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/study/NCT05035654
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05035654