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RECRUITING

NCT06609239

PHASE2

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

Sponsor: Sanofi

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

900

Start Date

2024-09-30

Completion Date

2031-01-20

Last Updated

2026-04-09

Healthy Volunteers

Conditions

Asthma

Interventions

DRUG

Lunsekimig

* Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection

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.

Locations (118)

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

Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400019

Sarasota, Florida, 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 PA- 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

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 : 0320011

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

Incor - Instituto do Coracao- Site Number : 0760011

São Paulo, Brazil

Investigational Site Number : 1240003

Hamilton, Ontario, Canada

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 : 1560053

Guangzhou, 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

Sakaidechō, Kagawa-ken, Japan

Brigham & Women's Hospital- Site Number : 8400034

Joso-Shi, Massachusetts, 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 : 4840008

Veracruz, 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