Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma

Enrolling by invitation · Phase 2

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT06609239

Run by

Sanofi

People needed

900

Starts

2024-09-30

Expected to finish

2031-01-20

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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 during the study intervention period and during 8 weeks following the last administration of study intervention. And:
• For female participants:
• incapable of becoming pregnant, or
• 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…

• Participants are excluded from the study if any of the following criteria apply:
• 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
• The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it is running

• Tucson Clinical Research Institute- Site Number : 8400085 — Tucson, Arizona, United States
• 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
• Tellabio International Research Services- Site Number : 8400083 — Pembroke Pines, Florida, United States
• Avanza Medical Research Center- Site Number : 8400135 — Pensacola, Florida, United States
• Ilumina Medical Research- Site Number : 8400095 — Saint Cloud, 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
• Clinical Research Associates of Central Pennsylvania- Site Number : 8400116 — DuBois, Pennsylvania, United States
• Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400007 — Pittsburgh, Pennsylvania, United States
• Orion Clinical Research- Site Number : 8400001 — Austin, Texas, United States
• Chandler Clinical Research Trials- Site Number : 8400075 — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.