| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05295459 | Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 2) | PHASE3 | COMPLETED | 182 | — | — | May 13, 2022 | Apr 2, 2025 | Feb 19, 2026 | 57 | United States, Belgium +4 |
| NCT05219968 | Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults | PHASE3 | COMPLETED | 196 | — | — | Jan 27, 2022 | Sep 16, 2024 | May 2, 2025 | 55 | United States, Austria +3 |
| NCT04041609 | LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study) | PHASE2 | COMPLETED | 71 | — | — | May 9, 2019 | Feb 4, 2021 | Jul 25, 2023 | 22 | Australia, Austria +3 |
The 3CS are nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. The diary is completed daily by study participants throughout the study. Each symptom is rated on a 4-point (0-3) scale where 0= none/absent symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores. The 3CS total score ranges from 0-9, with higher scores indicating worse symptoms.
The 3CS are nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. The diary is completed daily by study participants throughout the study. Each symptom/each question is rated on a 4-point (0-3) scale where 0= none/absent symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores. The 3CS total score ranges from 0-9, with higher scores indicating worse symptoms.
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.
| Arm | Type | Description |
|---|---|---|
| LYR-210 | EXPERIMENTAL | Single administration of LYR-210 drug matrix (7500 μg) |
| Sham procedure control | SHAM_COMPARATOR | Single mock administration procedure |
| 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 |
|---|---|---|
| LYR-210 | DRUG | LYR-210 drug matrix (mometasone furoate) |
| Sham procedure control | DRUG | Sham procedure control |
| Background therapy | OTHER | Daily Saline Irrigation |
| Sham comparator | OTHER | Sham comparator |
Inclusion Criteria: * Age ≥18 * Diagnosed as having CRS * Bilateral ethmoid disease confirmed on CT * Mean 3 cardinal symptom (3CS) score * Undergone at least 2 trials of medical treatments in the past * Has been informed of the nature of the study and provided written informed consent * Agrees to ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 5 | PHASE3 | Itepekimab, Mometasone furoate, lunsekimig |
| AstraZeneca PLC | AZN | 4 | PHASE3 | Tezepelumab |
| Eli Lilly and Company | LLY | 1 | PHASE3 | LY3650150, Standard therapy for INCS |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | — | Undisclosed |