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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522896-27 | Registry Identifier | CTIS | |
| U1111-1303-3645 | Registry Identifier | ICTRP |
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This is a phase 2, open-label extension study to evaluate the long-term safety and efficacy of lunsekimig in adult participants with asthma who have previously completed the parent studies. After completion of the parent study, eligible participants will be offered the opportunity to participate in the long-term extension (LTE) study with lunsekimig.
The study duration will be up to 148 weeks with a treatment duration being up to 144 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lunsekimig | Experimental | Participants will receive subcutaneous injection of lunsekimig according to established dosing interval |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lunsekimig | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Exposure-adjusted incidence rate of treatment-emergent adverse event (TEAE), including adverse events of special interest (AESI), and serious adverse event (SAE) | Exposure-adjusted incidence rate is defined as the number of patients with at least one specific treatment emergent adverse event in question per 100 patients taking the treatment for 1 year. | From study baseline to week 148 |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized rate of asthma exacerbation events | From study baseline to weeks 48, 96 and 144 | |
| Change from parent study baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) | From parent study baseline to weeks 48, 96 and 144 |
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Inclusion Criteria:
Participants who completed the treatment period of Study DRI16762 or ACT18301, including the EOT visit, as per protocol
Participants with stable background therapy with moderate or high-dose ICS in combination with the following controller medications, as maintained during the respective parent study in which they have participated:
Participants who are able and willing to participate in the open-label extension study, and to comply with requested study visits and procedures
Contraception for male and female participants during the study intervention period and during 8 weeks following the last administration of study intervention. And:
For female participants:
For male participants:
-- No sperm donation or cryopreserving sperm
- Capable of giving signed informed consent
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 participant's potential participation in a clinical trial.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chandler Clinical Research Trials- Site Number : 8400075 | Chandler | Arizona | 85224 | United States | ||
| Tucson Clinical Research Institute- Site Number : 8400085 |
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| Label | URL |
|---|---|
| LTS17231 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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| Change from parent study baseline in Asthma Control Questionnaire5 (ACQ-5) score | The ACQ-5 is a questionnaire that measures the adequacy of asthma control and any changes in asthma control that may occur spontaneously or as a result of treatment. The ACQ-5 has five questions on the asthma symptoms and patients are asked to recall how their asthma has been during the previous week and to respond on a 7-point scale for each question (0 = no impairment, 6 = maximum impairment). The ACQ-5 score is the mean of the 5 questions and, therefore, between 0 (totally controlled) and 6 (severely uncontrolled). A high score indicates low asthma control. | From parent study baseline to weeks 48, 96 and 144 |
| Proportion of participants with ≥0.5-point reduction in each ACQ-5 score as compared to parent study baseline score | Defined as ACQ-5 responder analysis | From parent study baseline to weeks 48, 96 and 144 |
| Change from parent study baseline in Asthma Quality of Life Questionnaire Standardized Activites for 12 years and older (AQLQ[S] +12) domain and total scores | The AQLQ(S) + 12 was designed as a self-administered patient reported outcome to measure the functional impairments that are most troublesome to adolescents and adults ≥12 years of age as a result of their asthma. The instrument is comprised of 32 items, each rated on a 7-point Likert scales from 1 to 7. Higher scores indicate better quality of life. | From parent study baseline to weeks 48, 96 and 144 |
| Serum lunsekimig concentrations | From study baseline to week 144 |
| Incidence and titer of anti-drug antibodies (ADA) against lunsekimig | From study baseline to week 144 |
| Tucson |
| Arizona |
| 85712 |
| United States |
| Allianz Research Institute - Aurora- Site Number : 8400026 | Aurora | Colorado | 80014 | United States |
| Western States Clinical Research- Site Number : 8400014 | Wheat Ridge | Colorado | 80033 | United States |
| Helix Biomedics- Site Number : 8400114 | Boynton Beach | Florida | 33435 | United States |
| Beautiful Minds Clinical Research Center- Site Number : 8400049 | Cutler Bay | Florida | 33157 | United States |
| Qway Research - Hialeah- Site Number : 8400015 | Hialeah | Florida | 33010 | United States |
| Clintex Research Group - Miami - Southwest 27th Avenue- Site Number : 8400048 | Miami | Florida | 33135 | United States |
| High Quality Research- Site Number : 8400039 | Miami | Florida | 33184 | United States |
| Innovations Biotech- Site Number : 8400040 | Miami | Florida | 33186 | United States |
| New Access Medical Center- Site Number : 8400043 | Miami | Florida | 33186 | United States |
| Deluxe Health Center- Site Number : 8400045 | Miami Lakes | Florida | 33014 | United States |
| Tellabio International Research Services- Site Number : 8400083 | Pembroke Pines | Florida | 33025 | United States |
| Avanza Medical Research Center- Site Number : 8400135 | Pensacola | Florida | 32503 | United States |
| Ilumina Medical Research- Site Number : 8400095 | Saint Cloud | Florida | 34769 | United States |
| Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400019 | Sarasota | Florida | 34239 | United States |
| Brigham & Women's Hospital- Site Number : 8400034 | Boston | Massachusetts | 02115 | United States |
| University of Michigan Health System - Ann Arbor- Site Number : 8400004 | Ann Arbor | Michigan | 48109 | United States |
| Midwest Clinical Research Center - St. Louis- Site Number : 8400006 | St Louis | Missouri | 63141 | United States |
| Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400029 | Charlotte | North Carolina | 28287 | United States |
| Asthma & Allergy Center - Toledo- Site Number : 8400017 | Toledo | Ohio | 43617 | United States |
| OK Clinical Research- Site Number : 8400021 | Edmond | Oklahoma | 73034 | United States |
| Clinical Research Associates of Central Pennsylvania- Site Number : 8400116 | DuBois | Pennsylvania | 15801 | United States |
| Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400007 | Pittsburgh | Pennsylvania | 15241 | United States |
| Orion Clinical Research- Site Number : 8400001 | Austin | Texas | 78759 | United States |
| South Texas Medical Research Institute - TTS Research- Site Number : 8400010 | Boerne | Texas | 78006 | United States |
| Baylor University Medical Center- Site Number : 8400002 | Dallas | Texas | 75246 | United States |
| Western Sky Medical Research- Site Number : 8400023 | El Paso | Texas | 79903 | United States |
| Metroplex Pulmonary and Sleep Center- Site Number : 8400022 | McKinney | Texas | 75069 | United States |
| Investigational Site Number : 0320007 | Berazategui | Buenos Aires | 1886 | Argentina |
| Investigational Site Number : 0320003 | La Plata | Buenos Aires | 1900 | Argentina |
| Investigational Site Number : 0320002 | Rosario | Santa Fe Province | 2000 | Argentina |
| Investigational Site Number : 0320006 | Rosario | Santa Fe Province | 2000 | Argentina |
| Investigational Site Number : 0320008 | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Investigational Site Number : 0320005 | Buenos Aires | 1121 | Argentina |
| Investigational Site Number : 0320012 | Buenos Aires | 1122 | Argentina |
| Investigational Site Number : 0320004 | Buenos Aires | 1414 | Argentina |
| Investigational Site Number : 0320001 | Buenos Aires | 1425 | Argentina |
| Investigational Site Number : 0320011 | Buenos Aires | 1425 | Argentina |
| Investigational Site Number : 0320009 | Mendoza | 5500 | Argentina |
| Investigational Site Number : 0320015 | Mendoza | 5500 | Argentina |
| Investigational Site Number : 0320010 | Santa Fe | 3000 | Argentina |
| Associacao Proar- Site Number : 0760003 | Salvador | Estado de Bahia | 40060-330 | Brazil |
| Universidade Federal de Goias- Site Number : 0760007 | Goiânia | Goiás | 74605-020 | Brazil |
| Centro de Estudos em Terapias Inovadoras- Site Number : 0760002 | Curitiba | Paraná | 80030-110 | Brazil |
| Instituto de Medicina Integral Professor Fernando Figueira- Site Number : 0760009 | Recife | Pernambuco | 50070-550 | Brazil |
| Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001 | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Hospital Dia do Pulmão- Site Number : 0760005 | Blumenau | Santa Catarina | 89030-101 | Brazil |
| CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760006 | Rio de Janeiro | 22241-180 | Brazil |
| Incor - Instituto do Coracao- Site Number : 0760011 | São Paulo | 05403-900 | Brazil |
| Investigational Site Number : 1240003 | Hamilton | Ontario | L8N 4A6 | Canada |
| Investigational Site Number : 1240004 | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Investigational Site Number : 1240001 | Trois-Rivières | Quebec | G8T 7A1 | Canada |
| Investigational Site Number : 1520013 | Concepción | Biobio | 4070094 | Chile |
| Investigational Site Number : 1520001 | Talca | Maule Region | 3465584 | Chile |
| Investigational Site Number : 1520006 | Santiago | Reg Metropolitana de Santiago | 7500587 | Chile |
| Investigational Site Number : 1520005 | Santiago | Reg Metropolitana de Santiago | 7500692 | Chile |
| Investigational Site Number : 1520004 | Santiago | Reg Metropolitana de Santiago | 7500698 | Chile |
| Investigational Site Number : 1520002 | Santiago | Reg Metropolitana de Santiago | 7750495 | Chile |
| Investigational Site Number : 1520008 | Quillota | Valparaiso | 2260877 | Chile |
| Investigational Site Number : 1520011 | Viña del Mar | Valparaiso | 2531172 | Chile |
| Investigational Site Number : 1560011 | Beijing | 100144 | China |
| Investigational Site Number : 1560010 | Changchun | 130021 | China |
| Investigational Site Number : 1560017 | Changsha | 410015 | China |
| Investigational Site Number : 1560053 | Guangzhou | 510000 | China |
| Investigational Site Number : 1560009 | Guangzhou | 510150 | China |
| Investigational Site Number : 1560001 | Guangzhou | 510163 | China |
| Investigational Site Number : 1560006 | Hefei | 230032 | China |
| Investigational Site Number : 1560014 | Hohhot | 010050 | China |
| Investigational Site Number : 1560007 | Nanchang | 330006 | China |
| Investigational Site Number : 1560002 | Pingxiang | 337055 | China |
| Investigational Site Number : 1560013 | Shanghai | 200433 | China |
| Investigational Site Number : 1560015 | Shenyang | 110004 | China |
| Investigational Site Number : 1560057 | Taiyuan | 030001 | China |
| Investigational Site Number : 1560005 | Wenzhou | 325027 | China |
| Investigational Site Number : 1560003 | Wuhan | 430030 | China |
| Investigational Site Number : 1560022 | Wuhan | 430030 | China |
| Investigational Site Number : 1560004 | Xuzhou | 221006 | China |
| Investigational Site Number : 1560016 | Yangzhou | 225000 | China |
| Investigational Site Number : 1560012 | Zhanjiang | 524004 | China |
| Investigational Site Number : 3560007 | Calicut | 673008 | India |
| Investigational Site Number : 3560009 | Hyderabad | 500084 | India |
| Investigational Site Number : 3560008 | Kanpur | 208001 | India |
| Investigational Site Number : 3560001 | Nagpur | 441203 | India |
| Investigational Site Number : 3560004 | Pune | 411057 | India |
| Investigational Site Number : 3760006 | Ashkelon | 7830604 | Israel |
| Investigational Site Number : 3760001 | Haifa | 3104802 | Israel |
| Investigational Site Number : 3760008 | Haifa | 3436212 | Israel |
| Investigational Site Number : 3760003 | Jerusalem | 9103102 | Israel |
| Investigational Site Number : 3760002 | Jerusalem | 9112001 | Israel |
| Investigational Site Number : 3760010 | Petah Tikva | 4941492 | Israel |
| Investigational Site Number : 3760004 | Rehovot | 7610001 | Israel |
| Investigational Site Number : 3760007 | Tel Aviv | 6423906 | Israel |
| Investigational Site Number : 3920002 | Sakaidechō | Kagawa-ken | 762-8550 | Japan |
| Investigational Site Number : 3920011 | Chūō | Tokyo | 104-0031 | Japan |
| Investigational Site Number : 3920005 | Ube | Yamaguchi | 755-8505 | Japan |
| Investigational Site Number : 3920008 | Fukushima | 960-1295 | Japan |
| Investigational Site Number : 3920006 | Kyoto | 610-0113 | Japan |
| Investigational Site Number : 3920009 | Kyoto | 612-8555 | Japan |
| Investigational Site Number : 3920012 | Miyazaki | 889-1692 | Japan |
| Investigational Site Number : 4840004 | Monterrey | Nuevo León | 66465 | Mexico |
| Investigational Site Number : 4840005 | San Juan del Río | Querétaro | 76800 | Mexico |
| Investigational Site Number : 4840007 | Mérida | Yucatán | 97070 | Mexico |
| Investigational Site Number : 4840002 | Chihuahua City | 31000 | Mexico |
| Investigational Site Number : 4840003 | Durango | 34000 | Mexico |
| Investigational Site Number : 4840008 | Veracruz | 91900 | Mexico |
| Investigational Site Number : 7100004 | Benoni | 1500 | South Africa |
| Investigational Site Number : 7100005 | Benoni | 1500 | South Africa |
| Investigational Site Number : 7100003 | Cape Town | 7530 | South Africa |
| Investigational Site Number : 7100002 | Cape Town | 7700 | South Africa |
| Investigational Site Number : 7100001 | Durban | 4001 | South Africa |
| Investigational Site Number : 7100006 | Pretoria | 0157 | South Africa |
| Investigational Site Number : 4100002 | Seoul | Seoul-teukbyeolsi | 03080 | South Korea |
| Investigational Site Number : 4100001 | Seoul | Seoul-teukbyeolsi | 03722 | South Korea |
| Investigational Site Number : 4100004 | Seoul | Seoul-teukbyeolsi | 05030 | South Korea |
| Investigational Site Number : 4100006 | Seoul | Seoul-teukbyeolsi | 05505 | South Korea |
| Investigational Site Number : 4100005 | Seoul | Seoul-teukbyeolsi | 06351 | South Korea |
| Investigational Site Number : 7920006 | Bursa | 16059 | Turkey (Türkiye) |
| Investigational Site Number : 7920002 | Istanbul | 34098 | Turkey (Türkiye) |
| Investigational Site Number : 7920003 | Istanbul | 34854 | Turkey (Türkiye) |
| Investigational Site Number : 7920005 | İzmit | 41001 | Turkey (Türkiye) |
| Investigational Site Number : 7920007 | Kayseri | 38039 | Turkey (Türkiye) |
| Investigational Site Number : 7920001 | Mersin | 33070 | Turkey (Türkiye) |
| Investigational Site Number : 8260001 | Cambridge | Cambridgeshire | CB2 2QQ | United Kingdom |
| Investigational Site Number : 8260004 | Glasgow | Glasgow City | G12 0YN | United Kingdom |
| Investigational Site Number : 8260005 | Chertsey | Surrey | KT16 0PZ | United Kingdom |
| Investigational Site Number : 8260008 | Bradford | BD9 6RJ | United Kingdom |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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