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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515912-27 | Registry Identifier | CTIS | |
| U1111-1308-9807 | Registry Identifier | ICTRP |
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This is a single-arm extension study to investigate the long-term safety, tolerability, and efficacy of lunsekimig in adult participants with inadequately controlled CRSwNP who have completed a previous lunsekimig CRSwNP clinical study (also referred to as the parent study ACT18207).
The study duration will be up to approximately 148 weeks per participant, including 144 weeks of treatment period and 4 weeks of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lunsekimig | Experimental | Participant will receive lunsekimig subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) daily for 144 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lunsekimig | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of participants with treatment-emergent adverse events (TEAEs) including adverse events of special interest (AESI), and serious adverse events (SAEs) | From baseline to Week 148 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sino-nasal Outcome Test 22 (SNOT-22) total score | The SNOT-22 is a 22-item health-related outcomes assessment. The 22-question SNOT-22 is scored as 0 (no problem) to 5 (problem as bad as it can be) with a total range from 0 to 110 (higher scores indicate poorer outcomes). | From the parent study baseline to Weeks 52, 96 and 144 |
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Inclusion Criteria:
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Modena Allergy + Asthma- Site Number : 8400005 | La Jolla | California | 92037 | United States | ||
| Sacramento Ear Nose & Throat - Roseville- Site Number : 8400003 |
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| Label | URL |
|---|---|
| LTS18300 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| Mometasone furoate nasal spray (MFNS) | Drug |
|
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| Change in Rhinosinusitis visual analog scale (VAS) |
The VAS for rhinosinusitis is used to evaluate the total severity. The participant is asked to indicate along a 10 centimeter straight horizontal line (VAS) the answer to the question: "How troublesome are your symptoms of your rhinosinusitis". The VAS ranks from 0 (Not troublesome) to 10 (Worst thinkable troublesome) and is measured in centimeters. |
| From the parent study baseline to Weeks 52, 96 and 144 |
| Change in The University of Pennsylvania Smell Identification Test (UPSIT) score | The UPSIT test is a rapid and easy-to-administer method to quantitatively assess human olfactory function. The test consists of four booklets, each containing 10 odorants with one odorant per page. Above each odorant strip is a multiple-choice question with four alternative words to describe the odor. Score depends on the amount of answers out of 40 possible correct answers. | From the parent study baseline to Weeks 52, 96 and 144 |
| Serum lunsekimig concentrations | From baseline to Week 144 |
| Anti-drug antibodies (ADA) against lunsekimig | From baseline to Week 144 |
| Roseville |
| California |
| 95661 |
| United States |
| Treasure Valley Medical Research- Site Number : 8400002 | Boise | Idaho | 83706 | United States |
| Essential Medical Research- Site Number : 8400020 | Tulsa | Oklahoma | 74137 | United States |
| McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8400017 | Bellaire | Texas | 77401 | United States |
| Pharmaceutical Research & Consulting- Site Number : 8400004 | Dallas | Texas | 75231 | United States |
| ENT Associates of Texas - McKinne- Site Number : 8400014 | McKinney | Texas | 75070 | United States |
| Alamo ENT Associates- Site Number : 8400001 | San Antonio | Texas | 78258 | United States |
| Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400008 | Norfolk | Virginia | 23510 | United States |
| Investigational Site Number : 0320002 | Rosario | Santa Fe Province | 2000 | Argentina |
| Investigational Site Number : 0320001 | Buenos Aires | 1121 | Argentina |
| Investigational Site Number : 0320003 | Mendoza | 5500 | Argentina |
| Investigational Site Number : 0560002 | Ghent | 9000 | Belgium |
| Investigational Site Number : 0560001 | Leuven | 3000 | Belgium |
| Investigational Site Number : 1000001 | Sofia | 1612 | Bulgaria |
| Investigational Site Number : 6160004 | Poznan | Greater Poland Voivodeship | 60-693 | Poland |
| Investigational Site Number : 6160002 | Krakow | Lesser Poland Voivodeship | 30-033 | Poland |
| Investigational Site Number : 6160007 | Wroclaw | Lower Silesian Voivodeship | 50-750 | Poland |
| Investigational Site Number : 6160001 | Warsaw | Masovian Voivodeship | 00-909 | Poland |
| Investigational Site Number : 6160005 | Warsaw | Masovian Voivodeship | 02-507 | Poland |
| Investigational Site Number : 6160003 | Katowice | Silesian Voivodeship | 40-611 | Poland |
| Investigational Site Number : 8260004 | Gloucester | Gloucestershire | GL1 3NN | United Kingdom |
| Investigational Site Number : 8260003 | Manchester | M13 9wl | United Kingdom |
| Investigational Site Number : 8260001 | Newcastle upon Tyne | NE7 7DN | United Kingdom |