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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Treatment Arm LYR-220 Design 1 | Experimental | Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1 |
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| 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 |
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| Part 2: Treatment Arm Bilateral sham procedure control | Sham Comparator | Bilateral sham procedure control |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LYR-220 Design 1 (Part 1 only) | Drug | LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1 |
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| Measure | Description | Time Frame |
|---|---|---|
| Product-related Unexpected Serious Adverse Events | Product-related unexpected serious adverse events | 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. | Through Week 25 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Percentage of subjects reporting treatment-emergent adverse events | Through Week 28 |
| Endoscopic Findings | Percentage of subjects with newly identified or worsened endoscopic findings in the ethmoid cavity (mild, moderate, or severe) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyra Investigational Site | Carlsbad | California | 92008 | United States | ||
| Lyra Investigational Site |
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2 subjects were randomized but did not receive the investigational product and are not included in the total count
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: LYR-220 Design 1 | Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1 LYR-220 Design 1: LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1 |
| FG001 | Part 1 and Part 2: LYR-220 Design 2 |
| 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 | Aug 30, 2022 | Sep 11, 2024 |
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| 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 |
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| Through Week 25 |
| Ophthalmic Assessment: Intraocular Pressure (IOP) | Percentage of subjects with clinically significant increase in IOP | Through Week 25 |
| Ophthalmic Assessment: Cataract | Percentage of subjects with newly identified or worsened cataract in one or both eyes | 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. | 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. | Through Week 28 |
| La Mesa |
| California |
| 91942 |
| United States |
| Lyra Investigational Site | Roseville | California | 95661 | United States |
| Lyra Investigational Site | Torrance | California | 90501 | United States |
| Lyra Investigational Site | Chicago | Illinois | 60208 | United States |
| Lyra Investigational Site | Chicago | Illinois | 60657 | United States |
| Lyra Investigational Site | New Albany | Indiana | 47150 | United States |
| Lyra Investigational Site | Louisville | Kentucky | 40205 | United States |
| Lyra Investigational Site | Marrero | Louisiana | 70072 | United States |
| Lyra Investigational Site | Baltimore | Maryland | 21204 | United States |
| Lyra Investigational Site | New Hyde Park | New York | 11042 | United States |
| Lyra Investigational Site | New York | New York | 10016 | United States |
| Lyra Investigational Site | Chapel Hill | North Carolina | 27599 | United States |
| Lyra Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Lyra Investigational Site | Bethlehem | Pennsylvania | 18017 | United States |
| Lyra Investigational Site | Orangeburg | South Carolina | 29118 | United States |
| Lyra Investigational Site | Spartanburg | South Carolina | 29303 | United States |
| Lyra Investigational Site | Fort Worth | Texas | 76109 | United States |
| Lyra Investigational Site | McKinney | Texas | 75069 | United States |
| Lyra Investigational Site | San Antonio | Texas | 78258 | United States |
| Lyra Investigational Site | South Ogden | Utah | 84405 | United States |
| Lyra Investigational Site | Spokane | Washington | 99201 | United States |
| Lyra Investigational Site | Bedford Park | 5042 | Australia |
| Lyra Investigational Site | Brisbane | Australia |
| Lyra Investigational Site | Melbourne | Australia |
Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2
LYR-220 Design 2: LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2
| FG002 | Part 2:Bilateral Sham Procedure | Bilateral sham procedure control Bilateral sham procedure control: Bilateral sham procedure control |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: LYR-220 Design 1 | Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1 LYR-220 Design 1: LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1 |
| BG001 | Part 1 and Part 2: LYR-220 Design 2 | Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2 LYR-220 Design 2: LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2 |
| BG002 | Part 2: Bilateral Sham Procedure | Bilateral sham procedure control Bilateral sham procedure control: Bilateral sham procedure control |
| 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, Categorical | 2 subjects were randomized but did not receive the investigational product. | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | 2 subjects were randomized but did not receive the investigational product. | Count of Participants | Participants |
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| Race (NIH/OMB) | 2 subjects were randomized but did not receive the investigational product | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| BMI | Subjects with non-missing height and/or weight. | Mean | Standard Deviation | kg/m² |
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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 | Product-related Unexpected Serious Adverse Events | Product-related unexpected serious adverse events | Safety Analysis Set | Posted | Count of Participants | Participants | Through Week 28 |
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| Primary | 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. | PK Analysis Set Design 1- Part 1, PK Analysis Set Design 2 - Part 1; PK Analysis Set Design 2 - Part 2 | Posted | Mean | Standard Deviation | pg/mL | Through Week 25 |
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| Secondary | Adverse Events | Percentage of subjects reporting treatment-emergent adverse events | Safety Analysis Set | Posted | Count of Participants | Participants | Through Week 28 |
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| Secondary | Endoscopic Findings | Percentage of subjects with newly identified or worsened endoscopic findings in the ethmoid cavity (mild, moderate, or severe) | Safety Analysis Set | Posted | Count of Participants | Participants | Through Week 25 |
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| Secondary | Ophthalmic Assessment: Intraocular Pressure (IOP) | Percentage of subjects with clinically significant increase in IOP | Safety Analysis Set | Posted | Number | participants | Through Week 25 |
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| Secondary | Ophthalmic Assessment: Cataract | Percentage of subjects with newly identified or worsened cataract in one or both eyes | Safety Analysis Set | Posted | Number | Participants | Through Week 25 |
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| Secondary | 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. | Efficacy Analysis Set - Part 2 | Posted | Mean | Full Range | Change from Baseline in SNOT-22 score | Through Week 28 |
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| Secondary | 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. | Efficacy Analysis Set - Part 2 | Posted | Mean | Standard Deviation | Change from Baseline in 3CS Score | Through Week 28 |
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Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months).
Standard definition of adverse events and serious adverse events was used in the trial.
All events were assesed for relationship to the study product and study procedure.
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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 | Part 1: LYR-220 Design 1 | Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1 LYR-220 Design 1: LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1 | 0 | 3 | 0 | 3 | 1 | 3 |
| EG001 | Part 1 and Part 2: LYR-220 Design 2 | Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2 LYR-220 Design 2: LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2 | 0 | 24 | 0 | 24 | 21 | 24 |
| EG002 | Part 2: Bilateral Sham Procedure | Bilateral sham procedure control Bilateral sham procedure control: Bilateral sham procedure control | 0 | 21 | 0 | 21 | 9 | 21 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Acute Sinusitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Chronic Sinusitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Nasal Odour | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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Except as approved by Sponsor, single center data will not be published before multicenter data, unless >1 year has elapsed since completion of the Study. PI may publish single center data provided that PI shall: i) provide a copy of the publication to Sponsor at least 60 days in advance of submission for publication; ii) delete Sponsor Confidential Information and make other reasonable changes; and iii) delay submission by up to 90 additional days to permit intellectual property filings.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Clinical Affairs | Lyra Therapeutics | 617-393-4600 | lyraclinical@lyratx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 24, 2023 | Sep 12, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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