Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma.
NCT ID: NCT06609239
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
900 participants
INTERVENTIONAL
2024-09-30
2031-01-20
Brief Summary
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The study duration will be up to 100 weeks with a treatment duration being up to 96 weeks.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lunsekimig
Participants will receive a subcutaneous injection of lunsekimig according to established dosing interval
Lunsekimig
* Pharmaceutical form: Solution for injection in vial
* Route of administration: Subcutaneous injection
Interventions
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Lunsekimig
* Pharmaceutical form: Solution for injection in vial
* Route of administration: Subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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:
* For Study DRI16762: At least 1 and no more than 2 additional controllers (eg, LABA, LAMA, LTRA, or methylxanthines) with or without oral prednisone
* For Study ACT18301: LABA with or without LTRA
3. Participants who are able and willing to participate in the open-label extension study, and to comply with requested study visits and procedures
4. Contraception for male and female participants
For female participants:
* must agree to use contraception/barrier
* not pregnant or breast feeding
* no eggs donation or cryopreserving eggs
For male participants:
* No sperm donation or cryopreserving sperm
5. Capable of giving signed informed consent
Exclusion Criteria
2. Participant who was diagnosed with a new pulmonary disease which may impair lung function
3. Current smoker or active vaping of any products and/or marijuana smoking
4. Prescription drug or substance abuse, including alcohol, considered significant by the Investigator
5. History of hypersensitivity or allergy to lunsekimig or to any of the excipients used in the presentation or in preparation for administration of lunsekimig, or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
6. Participants who are receiving prohibited concomitant medications
7. Participants who, during their participation in the parent study, developed an AE or an SAE deemed related to lunsekimig, which in the opinion of the Investigator could indicate that continued treatment with lunsekimig may present an unreasonable risk for the participant
8. Concurrent participation in any other clinical study, including non-interventional studies
9. Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized
10. Participants are employees of the investigative site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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Allianz Research Institute - Aurora- Site Number : 8400026
Aurora, Colorado, United States
Western States Clinical Research- Site Number : 8400014
Wheat Ridge, Colorado, United States
Helix Biomedics- Site Number : 8400114
Boynton Beach, Florida, United States
Beautiful Minds Clinical Research Center- Site Number : 8400049
Cutler Bay, Florida, United States
Qway Research - Hialeah- Site Number : 8400015
Hialeah, Florida, United States
Clintex Research Group - Miami - Southwest 27th Avenue- Site Number : 8400048
Miami, Florida, United States
High Quality Research- Site Number : 8400039
Miami, Florida, United States
Innovations Biotech- Site Number : 8400040
Miami, Florida, United States
New Access Medical Center- Site Number : 8400043
Miami, Florida, United States
Deluxe Health Center- Site Number : 8400045
Miami Lakes, Florida, United States
Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400019
Sarasota, Florida, United States
Brigham & Women's Hospital- Site Number : 8400034
Boston, Massachusetts, United States
University of Michigan Health System - Ann Arbor- Site Number : 8400004
Ann Arbor, Michigan, United States
Midwest Clinical Research Center - St. Louis- Site Number : 8400006
St Louis, Missouri, United States
Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400029
Charlotte, North Carolina, United States
Asthma & Allergy Center - Toledo- Site Number : 8400017
Toledo, Ohio, United States
OK Clinical Research- Site Number : 8400021
Edmond, Oklahoma, United States
Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400007
Pittsburgh, Pennsylvania, United States
Orion Clinical Research- Site Number : 8400001
Austin, Texas, United States
South Texas Medical Research Institute - TTS Research- Site Number : 8400010
Boerne, Texas, United States
Baylor University Medical Center- Site Number : 8400002
Dallas, Texas, United States
Western Sky Medical Research- Site Number : 8400023
El Paso, Texas, United States
Metroplex Pulmonary and Sleep Center- Site Number : 8400022
McKinney, Texas, United States
Investigational Site Number : 0320007
Berazategui, Buenos Aires, Argentina
Investigational Site Number : 0320003
La Plata, Buenos Aires, Argentina
Investigational Site Number : 0320002
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320006
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320008
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number : 0320005
Buenos Aires, , Argentina
Investigational Site Number : 0320004
Buenos Aires, , Argentina
Investigational Site Number : 0320001
Buenos Aires, , Argentina
Investigational Site Number : 0320009
Mendoza, , Argentina
Investigational Site Number : 0320010
Santa Fe, , Argentina
Associacao Proar- Site Number : 0760003
Salvador, Estado de Bahia, Brazil
Universidade Federal de Goias- Site Number : 0760007
Goiânia, Goiás, Brazil
Centro de Estudos em Terapias Inovadoras- Site Number : 0760002
Curitiba, Paraná, Brazil
Instituto de Medicina Integral Professor Fernando Figueira- Site Number : 0760009
Recife, Pernambuco, Brazil
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Dia do Pulmão- Site Number : 0760005
Blumenau, Santa Catarina, Brazil
CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760006
Rio de Janeiro, , Brazil
Investigational Site Number : 1240004
Sherbrooke, Quebec, Canada
Investigational Site Number : 1240001
Trois-Rivières, Quebec, Canada
Investigational Site Number : 1520001
Talca, Maule Region, Chile
Investigational Site Number : 1520006
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520005
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520004
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520008
Quillota, Región de Valparaíso, Chile
Investigational Site Number : 1520011
Viña del Mar, Región de Valparaíso, Chile
Investigational Site Number : 1560011
Beijing, , China
Investigational Site Number : 1560010
Changchun, , China
Investigational Site Number : 1560017
Changsha, , China
Investigational Site Number : 1560009
Guangzhou, , China
Investigational Site Number : 1560001
Guangzhou, , China
Investigational Site Number : 1560006
Hefei, , China
Investigational Site Number : 1560014
Hohhot, , China
Investigational Site Number : 1560007
Nanchang, , China
Investigational Site Number : 1560002
Pingxiang, , China
Investigational Site Number : 1560013
Shanghai, , China
Investigational Site Number : 1560015
Shenyang, , China
Investigational Site Number : 1560005
Wenzhou, , China
Investigational Site Number : 1560003
Wuhan, , China
Investigational Site Number : 1560004
Xuzhou, , China
Investigational Site Number : 1560016
Yangzhou, , China
Investigational Site Number : 1560012
Zhanjiang, , China
Investigational Site Number : 3560009
Hyderabad, , India
Investigational Site Number : 3560008
Kanpur, , India
Investigational Site Number : 3560007
Kozhikode, , India
Investigational Site Number : 3560001
Nagpur, , India
Investigational Site Number : 3560004
Pune, , India
Investigational Site Number : 3760006
Ashkelon, , Israel
Investigational Site Number : 3760001
Haifa, , Israel
Investigational Site Number : 3760008
Haifa, , Israel
Investigational Site Number : 3760003
Jerusalem, , Israel
Investigational Site Number : 3760002
Jerusalem, , Israel
Investigational Site Number : 3760010
Petah Tikva, , Israel
Investigational Site Number : 3760004
Rehovot, , Israel
Investigational Site Number : 3760007
Tel Aviv, , Israel
Investigational Site Number : 3920002
Sakaide-shi, Kagawa-ken, Japan
Investigational Site Number : 3920011
Chūō, Tokyo, Japan
Investigational Site Number : 3920005
Ube, Yamaguchi, Japan
Investigational Site Number : 3920008
Fukushima, , Japan
Investigational Site Number : 3920006
Kyoto, , Japan
Investigational Site Number : 3920009
Kyoto, , Japan
Investigational Site Number : 3920012
Miyazaki, , Japan
Investigational Site Number : 4840004
Monterrey, Nuevo León, Mexico
Investigational Site Number : 4840005
San Juan del Río, Querétaro, Mexico
Investigational Site Number : 4840007
Mérida, Yucatán, Mexico
Investigational Site Number : 4840002
Chihuahua City, , Mexico
Investigational Site Number : 4840003
Durango, , Mexico
Investigational Site Number : 7100004
Benoni, , South Africa
Investigational Site Number : 7100005
Benoni, , South Africa
Investigational Site Number : 7100003
Cape Town, , South Africa
Investigational Site Number : 7100002
Cape Town, , South Africa
Investigational Site Number : 7100001
Durban, , South Africa
Investigational Site Number : 7100006
Pretoria, , South Africa
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100004
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100006
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100005
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 7920006
Bursa, , Turkey (Türkiye)
Investigational Site Number : 7920002
Istanbul, , Turkey (Türkiye)
Investigational Site Number : 7920003
Istanbul, , Turkey (Türkiye)
Investigational Site Number : 7920004
Izmir, , Turkey (Türkiye)
Investigational Site Number : 7920005
İzmit, , Turkey (Türkiye)
Investigational Site Number : 7920007
Kayseri, , Turkey (Türkiye)
Investigational Site Number : 7920001
Mersin, , Turkey (Türkiye)
Investigational Site Number : 8260001
Cambridge, Cambridgeshire, United Kingdom
Investigational Site Number : 8260004
Glasgow, Glasgow City, United Kingdom
Investigational Site Number : 8260005
Chertsey, Surrey, United Kingdom
Investigational Site Number : 8260008
Bradford, , United Kingdom
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Related Links
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LTS17231 Plain Language Results Summary
Other Identifiers
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LTS17231
Identifier Type: -
Identifier Source: org_study_id
2025-522896-27
Identifier Type: REGISTRY
Identifier Source: secondary_id
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