Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma.
AIRPHRODITE
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
2 other identifiers
interventional
900
14 countries
118
Brief Summary
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 100 weeks with a treatment duration being up to 96 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Sep 2024
Longer than P75 for phase_2 asthma
118 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2024
CompletedFirst Posted
Study publicly available on registry
September 24, 2024
CompletedStudy Start
First participant enrolled
September 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 20, 2031
April 9, 2026
April 1, 2026
6.3 years
September 20, 2024
April 8, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (12)
Annualized rate of asthma exacerbation events
From study baseline to week 48
Annualized rate of asthma exacerbation events
From study baseline to week 96
Change from parent study baseline in prebronchodilator (BD) forced expiratory volume in 1 second (FEV1)
From parent study baseline to week 48
Change from parent study baseline in pre bronchodilator (BD) FEV1
From parent study baseline to week 96
Change from parent study baseline in Asthma Control Questionnaire5 (ACQ-5) score
From parent study baseline to week 48
- +7 more secondary outcomes
Study Arms (1)
Lunsekimig
EXPERIMENTALParticipants will receive a subcutaneous injection of lunsekimig according to established dosing interval
Interventions
* Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection
Eligibility Criteria
You may qualify if:
- Participants who completed the 48-week 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:
- 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
- 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
- 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
- Capable of giving signed informed consent
You may not qualify if:
- 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
- Participant who was diagnosed with a new pulmonary disease which may impair lung function
- Current smoker or active vaping of any products and/or marijuana smoking
- Prescription drug or substance abuse, including alcohol, considered significant by the Investigator
- 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
- Participants who are receiving prohibited concomitant medications
- 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
- Concurrent participation in any other clinical study, including non-interventional studies
- Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (118)
Tucson Clinical Research Institute- Site Number : 8400085
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
Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400019
Sarasota, Florida, 34239, 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 PA- 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 : 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 : 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 : 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, Región de Valparaíso, 2260877, Chile
Investigational Site Number : 1520011
Viña del Mar, Región de Valparaíso, 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 : 1560005
Wenzhou, 325027, China
Investigational Site Number : 1560003
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 : 3560009
Hyderabad, 500084, India
Investigational Site Number : 3560008
Kanpur, 208001, India
Investigational Site Number : 3560007
Kozhikode, 673008, 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
Brigham & Women's Hospital- Site Number : 8400034
Joso-Shi, Massachusetts, 3030005, 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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2024
First Posted
September 24, 2024
Study Start
September 30, 2024
Primary Completion (Estimated)
January 20, 2031
Study Completion (Estimated)
January 20, 2031
Last Updated
April 9, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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