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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004621-89 | EudraCT Number |
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This is a Phase II, Randomized, Blinded, Sham Procedure-Controlled, Parallel-Group Trial to Evaluate the Efficacy, Safety and Tolerability of LYR-210 in Adult Subjects with Chronic Sinusitis.
LYR-210 is a drug depot, which contains the anti-inflammatory medication mometasone furoate (MF) pre-loaded in a single use applicator. LYR-210 is intended to be placed bilaterally into the sino-nasal passages by an otolaryngologist. Once in place, each LYR-210 drug depot is designed to gradually deliver sustained topical doses of MF to the inflamed mucosal sinus tissue over 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LYR-210 (Low Dose) | Experimental | In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus |
|
| LYR-210 (High Dose) | Experimental | In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus |
|
| Sham Procedure | Sham Comparator | In-office bilateral sham procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LYR-210 | Drug | A single administration of LYR-210 depot |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline (CFBL) in Chronic Sinusitis Symptom Scores at Week 4 | Participants score their CS symptoms on a 4-point scale as follows: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom present but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The scores are summed and averaged over the proceeding 7 days; higher scores indicate higher severity of symptoms of CS. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the 22-item Sino-nasal Outcome Test (SNOT-22) Total Score at Week 24 | Participants score the severity of their symptoms and social/emotional consequences of CS on a 6-point scale: 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 scores are summed in the range of 0-110; higher scores indicate higher severity of symptoms or social/emotional consequences of CS. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brisbane and Woman's Hospital | Brisbane | Australia | ||||
| Monash Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34534410 | Background | Cervin A, Rimmer J, Wrobel A, Abelak Y, Brayton L, Kuang Y. Long-acting implantable corticosteroid matrix for chronic rhinosinusitis: Results of LANTERN Phase 2 randomized controlled study. Int Forum Allergy Rhinol. 2022 Feb;12(2):147-159. doi: 10.1002/alr.22883. Epub 2021 Sep 17. |
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All Individual Participant Data (IPD) that underlie results in a publication may be available to other researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | LYR-210 (Low Dose) | In-office bilateral placement of the LYR-210 drug depot (mometasone furoate 2500 µg) in the middle meatus LYR-210: A single administration of LYR-210 depot |
| FG001 | LYR-210 (High Dose) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 30, 2020 | May 10, 2023 |
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| Sham comparator | Other | Sham comparator |
|
| 24 weeks |
| CFBL in Chronic Sinusitis Symptom Scores at Week 24 | Participants score their CS symptoms on a 4-point scale as follows: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom present but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The scores are summed and averaged over the proceeding 7 days; higher scores indicate higher severity of symptoms of CS. | Week 24 |
| Participants With Improved Bilateral Zinreich Score at Week 24 | Each sinus is assigned a score based on the percentage of opacification as follows: 0 = 0%, 1 = 1% to 25%, 2 = 26% to 50%, 3 = 51% to 75%, 4 = 76 % to 99%, 5 = 100% or completely occluded. Each sinus pair has a bilateral score in the range of 0 to 10. Higher scores indicate higher severity of sinus opacification. Responder is defined as a participant with at least a 1-point decrease in the imaging score at Week 24 compared with baseline. | Week 24 |
| The Number of Participants With Treatment-related Adverse Events for up to 24 Weeks | To evaluate the safety and tolerability of LYR-210 | 24 weeks |
| Plasma Drug Concentrations of MF at Week 4 | To evaluate the pharmacokinetics of LYR-210 | 4 Weeks |
| Plasma Drug Concentrations of MF at Week 12 | To evaluate the pharmacokinetics of LYR-210 | 12 weeks |
| Clayton |
| 3168 |
| Australia |
| The ENT Centre | Hornsby | 2077 | Australia |
| Westmead Hospital | Westmead | 2145 | Australia |
| University Hospital for Otorhinolaryngology, Medical University of Graz | Vienna | Austria |
| Fakultní nemocnice Plzeň | Pilsen | Czech Republic | 305 99 | Czechia |
| Fakultni Nemocnice Hradec Kralove Klinika otorinolaryngologie a chirurgie hlavy a krku | Hradec Králové | Prague | 500 05 | Czechia |
| Fakultni Nemocnice Brno OR | Brno | Czechia |
| St Anne's Faculty Hospital | Brno | Czechia |
| Southern Clinical Trials Waitemata | Auckland | 0626 | New Zealand |
| Southern Clinical Trials Ltd | Christchurch | 8013 | New Zealand |
| Clinical Trials New Zealand | Hamilton | 3206 | New Zealand |
| Middlemore Clinical Trials | Papatoetoe | 2025 | New Zealand |
| P3 Research Tauranga | Tauranga | BOP 3110 | New Zealand |
| P3 Research Wellington | Wellington | 6021 | New Zealand |
| Wellington Hospital | Wellington | 6021 | New Zealand |
| Provita Sp. z o.o. Centrum Medyczne Angelius Provita | Katowice | Poland |
| Centrum Medyczne All-Med | Krakow | Poland |
| Centrum Medyczne Plejady | Krakow | Poland |
| Centrum Medyczne PROMED | Krakow | Poland |
| Centrum Zdrowia MDM | Warsaw | Poland |
| Vistamed Sp. z o.o. | Wroclaw | Poland |
In-office bilateral placement of the LYR-210 drug depot (mometasone furoate 7500 µg) in the middle meatus
LYR-210: A single administration of LYR-210 depot
| FG002 | Sham Procedure | In-office bilateral sham procedure Sham comparator: Sham comparator |
| COMPLETED |
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| NOT COMPLETED |
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The primary analysis set for efficacy is the Intent-to-treat (ITT) set which includes all randomized subjects who received the study treatment and had a post-Day 1 assessment available.
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| ID | Title | Description |
|---|---|---|
| BG000 | LYR-210 (Low Dose) | In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus LYR-210: A single administration of LYR-210 depot |
| BG001 | LYR-210 (High Dose) | In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus LYR-210: A single administration of LYR-210 depot |
| BG002 | Sham Procedure | In-office bilateral sham procedure Sham comparator: Sham comparator |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline (CFBL) in Chronic Sinusitis Symptom Scores at Week 4 | Participants score their CS symptoms on a 4-point scale as follows: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom present but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The scores are summed and averaged over the proceeding 7 days; higher scores indicate higher severity of symptoms of CS. | ITT analysis set: all randomized subjects who receive the study treatment or have a treatment attempt on Day 1 and have post-Day 1 assessments available | Posted | Least Squares Mean | Standard Error | score on a scale | Week 4 |
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| Secondary | Change From Baseline in the 22-item Sino-nasal Outcome Test (SNOT-22) Total Score at Week 24 | Participants score the severity of their symptoms and social/emotional consequences of CS on a 6-point scale: 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 scores are summed in the range of 0-110; higher scores indicate higher severity of symptoms or social/emotional consequences of CS. | Posted | Least Squares Mean | Standard Error | score on a scale | 24 weeks |
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| Secondary | CFBL in Chronic Sinusitis Symptom Scores at Week 24 | Participants score their CS symptoms on a 4-point scale as follows: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom present but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The scores are summed and averaged over the proceeding 7 days; higher scores indicate higher severity of symptoms of CS. | Posted | Least Squares Mean | Standard Error | score on a scale | Week 24 |
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| Secondary | Participants With Improved Bilateral Zinreich Score at Week 24 | Each sinus is assigned a score based on the percentage of opacification as follows: 0 = 0%, 1 = 1% to 25%, 2 = 26% to 50%, 3 = 51% to 75%, 4 = 76 % to 99%, 5 = 100% or completely occluded. Each sinus pair has a bilateral score in the range of 0 to 10. Higher scores indicate higher severity of sinus opacification. Responder is defined as a participant with at least a 1-point decrease in the imaging score at Week 24 compared with baseline. | The outcome measure is based on the Intent-to-treat (ITT) set which includes all randomized subjects who received the study treatment and had a post-Day 1 imaging assessment which could be analyzed by the imaging core lab. | Posted | Count of Participants | Participants | Week 24 |
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| Secondary | The Number of Participants With Treatment-related Adverse Events for up to 24 Weeks | To evaluate the safety and tolerability of LYR-210 | The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1. | Posted | Count of Participants | Participants | 24 weeks |
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| Secondary | Plasma Drug Concentrations of MF at Week 4 | To evaluate the pharmacokinetics of LYR-210 | Participants who had evaluable plasma concentration at week 4. | Posted | Mean | Standard Deviation | pg/mL | 4 Weeks |
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| Secondary | Plasma Drug Concentrations of MF at Week 12 | To evaluate the pharmacokinetics of LYR-210 | Participants who had evaluable plasma concentration at week 12. | Posted | Mean | Standard Deviation | pg/mL | 12 weeks |
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1 year
AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LYR-210 (Low Dose) | In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus LYR-210: A single administration of LYR-210 depot | 0 | 24 | 1 | 24 | 15 | 24 |
| EG001 | LYR-210 (High Dose) | In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus LYR-210: A single administration of LYR-210 depot | 0 | 23 | 0 | 23 | 13 | 23 |
| EG002 | Sham Procedure | In-office bilateral sham procedure Sham comparator: Sham comparator | 0 | 23 | 1 | 23 | 12 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acarodermatitis | Infections and infestations | Non-systematic Assessment |
| ||
| Chronic Sinusitis | Infections and infestations | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Facial Pain | General disorders | Non-systematic Assessment |
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| Chronic Sinusitis | Infections and infestations | Non-systematic Assessment |
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| Rhinitis | Infections and infestations | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lyra Clinical | Lyra Therapeutics | 617-393-4600 | lyraclinical@lyratx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 6, 2020 | May 10, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Australia |
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| Europe |
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In-office bilateral sham procedure
Sham comparator: Sham comparator
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