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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1280-5321 | Registry Identifier | ICTRP | |
| 2023-503385-24 | Registry Identifier | CTIS |
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This is a study of amlitelimab for the treatment of participants with moderate-to-severe asthma. The study will have a double-blind treatment period until Week 24 for each participant and an open-label treatment period where each participant will receive open-label amlitelimab from Week 24 onwards. The purpose of this study is to evaluate long-term safety, tolerability, and efficacy of amlitelimab for the treatment of adult participants with moderate-to-severe asthma who have previously been enrolled and completed the treatment period of the parent study. The study duration will be up to 156 weeks. The treatment duration will be up to 144 weeks. The number of visits will be 18.
The duration of the study for each participant will be up to 156 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group 1 | Experimental | Subcutaneous Injection as per protocol |
|
| Treatment group 2 | Experimental | Subcutaneous injection as per protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amlitelimab | Drug | Injection Solution: by subcutaneous injection (SCI) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with treatment-emergent adverse events | Percentage of participants with treatment emergent Adverse Events. | From baseline up to Week 156 (EOS of LTS17510) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who experienced adverse events. | Data reported for participants who experienced adverse events of special interest (AESI) and serious adverse events (SAEs). | From baseline up to Week 156 (End of Study [EOS] of LTS17510) |
| Annualized rate of severe exacerbation events over treatment period from parent study baseline |
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Inclusion Criteria:
For female participants:
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 potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bensch Research Associates- Site Number : 8400004 | Stockton | California | 95207 | United States | ||
| Helix Biomedics- Site Number : 8400029 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39393433 | Derived | Seluk L, Davis AE, Rhoads S, Wechsler ME. Novel asthma treatments: Advancing beyond approved novel step-up therapies for asthma. Ann Allergy Asthma Immunol. 2025 Jan;134(1):9-18. doi: 10.1016/j.anai.2024.09.016. Epub 2024 Oct 10. |
| Label | URL |
|---|---|
| LTS17510 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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This study will have a double-blind treatment period and an open-label treatment period
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This study will have a double-blind treatment period and an open-label treatment period after week 24
| Placebo |
| Drug |
Injection Solution: by subcutaneous injection (SCI) |
|
Severe exacerbation events over treatment period from parent study baseline are defined as: Worsening of asthma requiring the use of systemic corticosteroids for ≥3 days (or a single IM or IV injection of corticosteroids) or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or Hospitalization or emergency room visit or urgent care visit because of asthma, requiring systemic corticosteroids. |
| From baseline of the parent study up to Week 144 (End of Treatment [EOT] of LTS17510) |
| Annualized rate of severe exacerbation events over treatment period from LTS17510 study baseline | Severe exacerbation events over treatment period from LTS17510 study baseline defined as: Worsening of asthma requiring the use of systemic corticosteroids for ≥3 days (or a single IM or IV injection of corticosteroids) or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or Hospitalization or emergency room visit or urgent care visit because of asthma, requiring systemic corticosteroids. | From baseline of the LTS17510 study Up to Week 144 (EOT of LTS17510) |
| Time to first exacerbation event from LTS17510 study baseline | From baseline of the LTS17510 study Up to Week 144 (EOT of LTS17510) |
| Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from parent study baseline | Severe asthma exacerbations are defined as: Worsening of asthma requiring the use of systemic corticosteroids for ≥3 days (or a single IM or IV injection of corticosteroids) or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or Hospitalization or emergency room visit or urgent care visit because of asthma, requiring systemic corticosteroids. | From baseline of the parent study up to Week 144 (EOT of LTS17510) |
| Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from LTS17510 study baseline | Severe asthma exacerbations are defined as: Worsening of asthma requiring the use of systemic corticosteroids for ≥3 days (or a single IM or IV injection of corticosteroids) or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or Hospitalization or emergency room visit or urgent care visit because of asthma, requiring systemic corticosteroids. | From baseline of the LTS17510 study up to Week 144 (EOT of LTS17510) |
| Change from parent study baseline in prebronchodilator (BD) and post-BD forced expiratory volume in 1 second (FEV1) at each spirometry endpoint | From baseline of parent study up to week 144 (EOT of LTS17510) |
| Change from LTS17510 study baseline in pre bronchodilator (BD) and post-BD forced expiratory volume in 1 second (FEV1) at each spirometry endpoint | From baseline of LTS17510 study up to week 144 (EOT of LTS17510) |
| Change from parent study baseline in pre-BD and post-BD peak expiratory flow [PEF] at each spirometry endpoint | From baseline of parent study up to Week 144 (EOT of LTS17510) |
| Change from LTS17510 study baseline in pre-BD and post-BD peak expiratory flow [PEF] at each spirometry endpoint | From baseline of LTS17510 study up to Week 144 (EOT of LTS17510) |
| Change from parent study baseline in Pre-BD and post-BD forced vital capacity [FVC] at each spirometry endpoint | From baseline of parent study up to Week 144 (EOT of LTS17510) |
| Change from LTS17510 study Baseline in Pre-BD and post-BD forced vital capacity [FVC] at each spirometry endpoint | From baseline of lTS17510 study up to Week 144 (EOT of LTS17510) |
| Change from parent study baseline in pre-BD and post-BD forced expiratory flow [FEF] 25% to 75%) at each spirometry endpoint | From baseline of parent study up to Week 144 (EOT of LTS17510) |
| Change from LTS17510 study baseline in pre-BD and post-BD forced expiratory flow [FEF] 25% to 75%) at each spirometry endpoint | From baseline of LTS17510 study up to Week 144 (EOT of LTS17510) |
| Change from parent study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores | The ACQ is a validated questionnaire that measures the adequacy of asthma control and any changes in asthma control that may occur spontaneously or as a result of treatment. Each item of the ACQ is measured on a 7-point response scale (0=no impairment, 6=maximum impairment). The ACQ score is the mean of the item responses and ranges from 0 (totally controlled) and 6 (severely uncontrolled). | From parent study baseline up to Week 144 (EOT of LTS17510) |
| Change from LTS17510 study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores | The ACQ is a validated questionnaire that measures the adequacy of asthma control and any changes in asthma control that may occur spontaneously or as a result of treatment. Each item of the ACQ is measured on a 7-point response scale (0=no impairment, 6=maximum impairment). The ACQ score is the mean of the item responses and ranges from 0 (totally controlled) and 6 (severely uncontrolled). | From LTS17510 study baseline up to Week 144 (EOT of LTS17510) |
| Change from parent study baseline in Fractional Exhaled Nitric Oxide (FeNO) | From parent study baseline up to Week 144 (EOT of LTS17510) |
| Change from LTS17510 study baseline in Fractional Exhaled Nitric Oxide (FeNO) | From LTS17510 study baseline up to Week 144 (EOT of LTS17510) |
| Serum amlitelimab concentrations | From baseline up to Week156 (EOS of LTS17510) |
| Incidence of anti- amlitelimab antibody positive response | From baseline up to Week 156 (EOS of LTS17510) |
| Change from parent study baseline and from LTS17510 in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ [S]) Self-Administered Score | The AQLQ(S) was designed as a self-administered participant 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 over the past two weeks. The instrument is comprised of 32 items, each rated on a 7-point Likert scales from 1 to 7. | From baseline up to Weeks 144 (EOT of LTS17510) |
| Boynton Beach |
| Florida |
| 33435 |
| United States |
| Savin Medical Group - Miami Lakes- Site Number : 8400015 | Miami Lakes | Florida | 33014 | United States |
| Pines Care Research Center- Site Number : 8400028 | Pembroke Pines | Florida | 33025 | United States |
| Treasure Valley Medical Research- Site Number : 8400031 | Boise | Idaho | 83706 | United States |
| Johns Hopkins Bayview Medical Center- Site Number : 8400012 | Baltimore | Maryland | 21224 | United States |
| OK Clinical Research- Site Number : 8400001 | Edmond | Oklahoma | 73034 | United States |
| South Texas Medical Research Institute - TTS Research- Site Number : 8400011 | Boerne | Texas | 78006 | United States |
| Investigational Site Number : 0320008 | La Plata | Buenos Aires | 1900 | Argentina |
| Investigational Site Number : 0320005 | Rosario | Santa Fe Province | 2000 | Argentina |
| Investigational Site Number : 0320006 | Rosario | Santa Fe Province | 2000 | Argentina |
| Investigational Site Number : 0320007 | Rosario | Santa Fe Province | 2000 | Argentina |
| Investigational Site Number : 0320004 | Buenos Aires | 1121 | Argentina |
| Investigational Site Number : 0320003 | Buenos Aires | 1414 | Argentina |
| Investigational Site Number : 0320001 | Buenos Aires | 1425 | Argentina |
| Investigational Site Number : 0320002 | Buenos Aires | 1425 | Argentina |
| Investigational Site Number : 0320009 | Buenos Aires | 1650 | Argentina |
| Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760002 | Vitória | Espírito Santo | 29055-450 | Brazil |
| Associacao Proar- Site Number : 0760004 | Salvador | Estado de Bahia | 40060-330 | Brazil |
| Instituto Méderi de Pesquisa e Saúde- Site Number : 0760001 | Passo Fundo | Rio Grande do Sul | 99010-170 | Brazil |
| Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760007 | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760006 | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Clinica de Alergia Martti Antila- Site Number : 0760003 | Sorocaba | São Paulo | 18040-425 | Brazil |
| Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760008 | São Paulo | 05403-000 | Brazil |
| Investigational Site Number : 1240008 | Ottawa | Ontario | K1G 6C6 | Canada |
| Investigational Site Number : 1240007 | Trois-Rivières | Quebec | G8T 7A1 | Canada |
| Investigational Site Number : 1520006 | Talca | Maule Region | 3465584 | Chile |
| Investigational Site Number : 1520001 | Santiago | Reg Metropolitana de Santiago | 7500692 | Chile |
| Investigational Site Number : 1520003 | Santiago | Reg Metropolitana de Santiago | 7750495 | Chile |
| Investigational Site Number : 1520008 | Santiago | Reg Metropolitana de Santiago | 8380465 | Chile |
| Investigational Site Number : 1520005 | Quillota | Valparaiso | 2260877 | Chile |
| Investigational Site Number : 3480009 | Edelény | 3780 | Hungary |
| Investigational Site Number : 3480011 | Gödöllő | 2100 | Hungary |
| Investigational Site Number : 3480006 | Püspökladány | 4150 | Hungary |
| Investigational Site Number : 3480012 | Százhalombatta | 2440 | Hungary |
| Investigational Site Number : 3800004 | Naples | Napoli | 80131 | Italy |
| Investigational Site Number : 3800003 | Rome | Roma | 00168 | Italy |
| Investigational Site Number : 3800001 | Verona | 37134 | Italy |
| Investigational Site Number : 3920010 | Sakai | Osaka | 591-8555 | Japan |
| Investigational Site Number : 3920004 | Chūō | Tokyo | 104-0031 | Japan |
| Investigational Site Number : 3920019 | Hiroshima | 732-0052 | Japan |
| Investigational Site Number : 3920005 | Tokyo | 103-0027 | Japan |
| Investigational Site Number : 3920001 | Tokyo | 140-8522 | Japan |
| Investigational Site Number : 4840001 | Guadalajara | Jalisco | 44100 | Mexico |
| Investigational Site Number : 4840005 | Guadalajara | Jalisco | 44670 | Mexico |
| Investigational Site Number : 4840008 | Mérida | Yucatán | 97070 | Mexico |
| Investigational Site Number : 4840002 | Chihuahua City | 31000 | Mexico |
| Investigational Site Number : 6160001 | Poznan | Greater Poland Voivodeship | 60-693 | Poland |
| Investigational Site Number : 6160006 | Krakow | Lesser Poland Voivodeship | 31-209 | Poland |
| Investigational Site Number : 6160007 | Tarnów | Lesser Poland Voivodeship | 33-100 | Poland |
| Investigational Site Number : 6160004 | Bialystok | Podlaskie Voivodeship | 15-044 | Poland |
| Investigational Site Number : 6160002 | Gdansk | Pomeranian Voivodeship | 80-405 | Poland |
| Investigational Site Number : 6160003 | Elblag | 82-300 | Poland |
| Investigational Site Number : 7100007 | Benoni | 1500 | South Africa |
| Investigational Site Number : 7100002 | Cape Town | 7530 | South Africa |
| Investigational Site Number : 7100001 | Cape Town | 7700 | South Africa |
| Investigational Site Number : 7100004 | Middelburg | 1055 | South Africa |
| Investigational Site Number : 4100004 | Daegu | Gyeongsangbuk-do | 42415 | South Korea |
| Investigational Site Number : 4100001 | Seoul | Seoul-teukbyeolsi | 03722 | South Korea |
| Investigational Site Number : 4100005 | Seoul | Seoul-teukbyeolsi | 05030 | South Korea |
| Investigational Site Number : 4100002 | Seoul | Seoul-teukbyeolsi | 05505 | South Korea |
| Investigational Site Number : 4100006 | Seoul | Seoul-teukbyeolsi | 06591 | South Korea |
| Investigational Site Number : 7920001 | Istanbul | 34098 | Turkey (Türkiye) |
| Investigational Site Number : 7920003 | Izmir | 35100 | Turkey (Türkiye) |
| Investigational Site Number : 7920005 | İzmit | 41001 | Turkey (Türkiye) |
| Investigational Site Number : 7920008 | Kayseri | 38039 | Turkey (Türkiye) |
| Investigational Site Number : 7920002 | Mersin | 33070 | Turkey (Türkiye) |
| Investigational Site Number : 8260001 | 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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