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Clinical Trials in India / NCT06609239
Enrolling by invitation Phase 2

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

NCT06609239 · tracked via the Priya Life Science India tracker
Sponsor
Sanofi
Phase
Phase 2
Started
2024-09-30
Last updated
2026-08-13

Condition(s) studied

Asthma

Investigational drug(s) / intervention(s)

Lunsekimig

Lunsekimig: * Pharmaceutical form: Solution for injection in vial or pre-filled syringe (PFS) * Route of administration: Subcutaneous injection

Study 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 148 weeks with a treatment duration being up to 144 weeks.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: 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.

Primary outcome measure(s)

Trial sites (127)

FacilityCityRegionStatus
Chandler Clinical Research Trials- Site Number : 8400075 Chandler Arizona
Tucson Clinical Research Institute- Site Number : 8400085 Tucson Arizona
Allianz Research Institute - Aurora- Site Number : 8400026 Aurora Colorado
Western States Clinical Research- Site Number : 8400014 Wheat Ridge Colorado
Helix Biomedics- Site Number : 8400114 Boynton Beach Florida
Beautiful Minds Clinical Research Center- Site Number : 8400049 Cutler Bay Florida
Qway Research - Hialeah- Site Number : 8400015 Hialeah Florida
Clintex Research Group - Miami - Southwest 27th Avenue- Site Number : 8400048 Miami Florida
High Quality Research- Site Number : 8400039 Miami Florida
Innovations Biotech- Site Number : 8400040 Miami Florida
New Access Medical Center- Site Number : 8400043 Miami Florida
Deluxe Health Center- Site Number : 8400045 Miami Lakes Florida
Tellabio International Research Services- Site Number : 8400083 Pembroke Pines Florida
Avanza Medical Research Center- Site Number : 8400135 Pensacola Florida
Ilumina Medical Research- Site Number : 8400095 Saint Cloud Florida
Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400019 Sarasota Florida
Brigham & Women's Hospital- Site Number : 8400034 Boston Massachusetts
University of Michigan Health System - Ann Arbor- Site Number : 8400004 Ann Arbor Michigan
Midwest Clinical Research Center - St. Louis- Site Number : 8400006 St Louis Missouri
Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400029 Charlotte North Carolina
Asthma & Allergy Center - Toledo- Site Number : 8400017 Toledo Ohio
OK Clinical Research- Site Number : 8400021 Edmond Oklahoma
Clinical Research Associates of Central Pennsylvania- Site Number : 8400116 DuBois Pennsylvania
Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400007 Pittsburgh Pennsylvania
Orion Clinical Research- Site Number : 8400001 Austin Texas
South Texas Medical Research Institute - TTS Research- Site Number : 8400010 Boerne Texas
Baylor University Medical Center- Site Number : 8400002 Dallas Texas
Western Sky Medical Research- Site Number : 8400023 El Paso Texas
Metroplex Pulmonary and Sleep Center- Site Number : 8400022 McKinney Texas
Investigational Site Number : 0320007 Berazategui Buenos Aires
Investigational Site Number : 0320003 La Plata Buenos Aires
Investigational Site Number : 0320002 Rosario Santa Fe Province
Investigational Site Number : 0320006 Rosario Santa Fe Province
Investigational Site Number : 0320008 San Miguel de Tucumán Tucumán Province
Investigational Site Number : 0320005 Buenos Aires Argentina
Investigational Site Number : 0320012 Buenos Aires Argentina
Investigational Site Number : 0320004 Buenos Aires Argentina
Investigational Site Number : 0320001 Buenos Aires Argentina
Investigational Site Number : 0320011 Buenos Aires Argentina
Investigational Site Number : 0320009 Mendoza Argentina

+ 87 more sites — see the full list on the official registry below.

More Sanofi trials in India

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06609239 on ClinicalTrials.gov ↗ ← All trials in India