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Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma.
NCT06609239 · Sanofi
In plain English
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Official title
An Open Label Extension Study to Evaluate the Long-term Safety and Efficacy of Subcutaneous Lunsekimig in Adult Participants With Asthma Who Participated in Study DRI16762 or ACT18301
About this study
Enter Intervention Groups
Eligibility criteria
Inclusion Criteria:
1. Participants who completed the 48-week treatment period of Study DRI16762 or ACT18301, including the EOT visit, as per protocol
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: Participants are excluded from the study if any of the following criteria apply:
1. Participant who developed a new medical condition or a change in status of an established medical condition or requires a new treatment or medication prior to enrollment that, per Investigator's medical judgement would adversely affect participation of the participant in this study or would require permanent lunsekimig discontinuation, or participants potentially at risk of noncompliance to study procedures
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.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study design
Enrollment target: 900 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-09-30
Estimated completion: 2031-01-20
Last updated: 2026-04-09
Interventions
Drug: Lunsekimig
Primary outcomes
- • Number of participants having any treatmentemergent adverse event (TEAE), including adverse events of special interest (AESI), and serious adverse event (SAE) (From study baseline to week 100)
Sponsor
Sanofi · industry
Contacts & investigators
ContactTrial Transparency email recommended (Toll free for US & Canada) · contact · contact-us@sanofi.com · 800-633-1610
All locations (118)
Tucson Clinical Research Institute- Site Number : 8400085Recruiting
Tucson, Arizona, United States
Allianz Research Institute - Aurora- Site Number : 8400026Recruiting
Aurora, Colorado, United States
Western States Clinical Research- Site Number : 8400014Recruiting
Wheat Ridge, Colorado, United States
Helix Biomedics- Site Number : 8400114Recruiting
Boynton Beach, Florida, United States
Beautiful Minds Clinical Research Center- Site Number : 8400049Recruiting
Cutler Bay, Florida, United States
Qway Research - Hialeah- Site Number : 8400015Recruiting
Hialeah, Florida, United States
Clintex Research Group - Miami - Southwest 27th Avenue- Site Number : 8400048Active Not Recruiting
Miami, Florida, United States
High Quality Research- Site Number : 8400039Recruiting
Miami, Florida, United States
Innovations Biotech- Site Number : 8400040Recruiting
Miami, Florida, United States
New Access Medical Center- Site Number : 8400043Recruiting
Miami, Florida, United States
Deluxe Health Center- Site Number : 8400045Recruiting
Miami Lakes, Florida, United States
Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400019Recruiting
Sarasota, Florida, United States
University of Michigan Health System - Ann Arbor- Site Number : 8400004Recruiting
Ann Arbor, Michigan, United States
Midwest Clinical Research Center - St. Louis- Site Number : 8400006Recruiting
St Louis, Missouri, United States
Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400029Recruiting
Charlotte, North Carolina, United States
Asthma & Allergy Center - Toledo- Site Number : 8400017Recruiting
Toledo, Ohio, United States
OK Clinical Research- Site Number : 8400021Recruiting
Edmond, Oklahoma, United States
Clinical Research Associates of Central PA- Site Number : 8400116Recruiting
DuBois, Pennsylvania, United States
Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400007Recruiting
Pittsburgh, Pennsylvania, United States
Orion Clinical Research- Site Number : 8400001Recruiting
Austin, Texas, United States
South Texas Medical Research Institute - TTS Research- Site Number : 8400010Recruiting
Boerne, Texas, United States
Baylor University Medical Center- Site Number : 8400002Recruiting
Dallas, Texas, United States
Western Sky Medical Research- Site Number : 8400023Recruiting
El Paso, Texas, United States
Metroplex Pulmonary and Sleep Center- Site Number : 8400022Recruiting
McKinney, Texas, United States
Investigational Site Number : 0320007Recruiting
Berazategui, Buenos Aires, Argentina
Investigational Site Number : 0320003Recruiting
La Plata, Buenos Aires, Argentina
Investigational Site Number : 0320002Recruiting
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320006Recruiting
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320008Recruiting
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number : 0320005Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0320004Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0320001Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0320011Recruiting
Buenos Aires, Argentina
Investigational Site Number : 0320009Recruiting
Mendoza, Argentina
Investigational Site Number : 0320010Recruiting
Santa Fe, Argentina
Associacao Proar- Site Number : 0760003Recruiting
Salvador, Estado de Bahia, Brazil
Universidade Federal de Goias- Site Number : 0760007Recruiting
Goiânia, Goiás, Brazil
Centro de Estudos em Terapias Inovadoras- Site Number : 0760002Recruiting
Curitiba, Paraná, Brazil
Instituto de Medicina Integral Professor Fernando Figueira- Site Number : 0760009Recruiting
Recife, Pernambuco, Brazil
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Dia do Pulmão- Site Number : 0760005Recruiting
Blumenau, Santa Catarina, Brazil
CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760006Recruiting
Rio de Janeiro, Brazil
Incor - Instituto do Coracao- Site Number : 0760011Recruiting
São Paulo, Brazil
Investigational Site Number : 1240003Recruiting
Hamilton, Ontario, Canada
Investigational Site Number : 1240004Recruiting
Sherbrooke, Quebec, Canada
Investigational Site Number : 1240001Active Not Recruiting
Trois-Rivières, Quebec, Canada
Investigational Site Number : 1520001Active Not Recruiting
Talca, Maule Region, Chile
Investigational Site Number : 1520006Active Not Recruiting
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520005Active Not Recruiting
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520004Active Not Recruiting
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520002Active Not Recruiting
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520008Active Not Recruiting
Quillota, Valparaiso, Chile
Investigational Site Number : 1520011Active Not Recruiting
Viña del Mar, Valparaiso, Chile
Investigational Site Number : 1560011Recruiting
Beijing, China
Investigational Site Number : 1560010Recruiting
Changchun, China
Investigational Site Number : 1560017Recruiting
Changsha, China
Investigational Site Number : 1560053Recruiting
Guangzhou, China
Investigational Site Number : 1560009Recruiting
Guangzhou, China
Investigational Site Number : 1560001Recruiting
Guangzhou, China
Investigational Site Number : 1560006Recruiting
Hefei, China
Investigational Site Number : 1560014Recruiting
Hohhot, China
Investigational Site Number : 1560007Recruiting
Nanchang, China
Investigational Site Number : 1560002Recruiting
Pingxiang, China
Investigational Site Number : 1560013Recruiting
Shanghai, China
Investigational Site Number : 1560015Recruiting
Shenyang, China
Investigational Site Number : 1560005Recruiting
Wenzhou, China
Investigational Site Number : 1560003Recruiting
Wuhan, China
Investigational Site Number : 1560004Recruiting
Xuzhou, China
Investigational Site Number : 1560016Recruiting
Yangzhou, China
Investigational Site Number : 1560012Recruiting
Zhanjiang, China
Investigational Site Number : 3560009Recruiting
Hyderabad, India
Investigational Site Number : 3560008Recruiting
Kanpur, India
Investigational Site Number : 3560007Recruiting
Kozhikode, India
Investigational Site Number : 3560001Active Not Recruiting
Nagpur, India
Investigational Site Number : 3560004Recruiting
Pune, India
Investigational Site Number : 3760006Recruiting
Ashkelon, Israel
Investigational Site Number : 3760001Recruiting
Haifa, Israel
Investigational Site Number : 3760008Recruiting
Haifa, Israel
Investigational Site Number : 3760003Recruiting
Jerusalem, Israel
Investigational Site Number : 3760002Recruiting
Jerusalem, Israel
Investigational Site Number : 3760010Recruiting
Petah Tikva, Israel
Investigational Site Number : 3760004Recruiting
Rehovot, Israel
Investigational Site Number : 3760007Recruiting
Tel Aviv, Israel
Investigational Site Number : 3920002Recruiting
Sakaidechō, Kagawa-ken, Japan
Brigham & Women's Hospital- Site Number : 8400034Recruiting
Joso-Shi, Massachusetts, Japan
Investigational Site Number : 3920011Active Not Recruiting
Chūō, Tokyo, Japan
Investigational Site Number : 3920005Recruiting
Ube, Yamaguchi, Japan
Investigational Site Number : 3920008Active Not Recruiting
Fukushima, Japan
Investigational Site Number : 3920006Recruiting
Kyoto, Japan
Investigational Site Number : 3920009Recruiting
Kyoto, Japan
Investigational Site Number : 3920012Active Not Recruiting
Miyazaki, Japan
Investigational Site Number : 4840004Recruiting
Monterrey, Nuevo León, Mexico
Investigational Site Number : 4840005Recruiting
San Juan del Río, Querétaro, Mexico
Investigational Site Number : 4840007Recruiting
Mérida, Yucatán, Mexico
Investigational Site Number : 4840002Recruiting
Chihuahua City, Mexico
Investigational Site Number : 4840003Recruiting
Durango, Mexico
Investigational Site Number : 4840008Recruiting
Veracruz, Mexico
Investigational Site Number : 7100004Recruiting
Benoni, South Africa
Investigational Site Number : 7100005Recruiting
Benoni, South Africa
Investigational Site Number : 7100003Recruiting
Cape Town, South Africa
Investigational Site Number : 7100002Recruiting
Cape Town, South Africa
Investigational Site Number : 7100001Recruiting
Durban, South Africa
Investigational Site Number : 7100006Recruiting
Pretoria, South Africa
Investigational Site Number : 4100002Recruiting
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100001Recruiting
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100004Recruiting
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100006Recruiting
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100005Recruiting
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 7920006Recruiting
Bursa, Turkey (Türkiye)
Investigational Site Number : 7920002Recruiting
Istanbul, Turkey (Türkiye)
Investigational Site Number : 7920003Recruiting
Istanbul, Turkey (Türkiye)
Investigational Site Number : 7920005Recruiting
İzmit, Turkey (Türkiye)
Investigational Site Number : 7920007Recruiting
Kayseri, Turkey (Türkiye)
Investigational Site Number : 7920001Recruiting
Mersin, Turkey (Türkiye)
Investigational Site Number : 8260001Recruiting
Cambridge, Cambridgeshire, United Kingdom
Investigational Site Number : 8260004Recruiting
Glasgow, Glasgow City, United Kingdom
Investigational Site Number : 8260005Recruiting
Chertsey, Surrey, United Kingdom
Investigational Site Number : 8260008Recruiting
Bradford, United Kingdom