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

NCT06609239 | Enrolling By Invitation Phase 2 DMC FDA Drug

• 3 other identifiers: LTS172312025-522896-27U1111-1303-3645
• Study Type: interventional
• Target: 900
• Locations: 14 countries
• Sites: 127

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

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Exposure-adjusted incidence rate of treatment-emergent adverse event (TEAE), including adverse events of special interest (AESI), and serious adverse event (SAE)

  Exposure-adjusted incidence rate is defined as the number of patients with at least one specific treatment emergent adverse event in question per 100 patients taking the treatment for 1 year.

  From study baseline to week 148

Secondary Outcomes (7)

• Annualized rate of asthma exacerbation events

  From study baseline to weeks 48, 96 and 144

• Change from parent study baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)

  From parent study baseline to weeks 48, 96 and 144

• Change from parent study baseline in Asthma Control Questionnaire5 (ACQ-5) score

  From parent study baseline to weeks 48, 96 and 144

• Proportion of participants with ≥0.5-point reduction in each ACQ-5 score as compared to parent study baseline score

  From parent study baseline to weeks 48, 96 and 144

• Change from parent study baseline in Asthma Quality of Life Questionnaire Standardized Activites for 12 years and older (AQLQ[S] +12) domain and total scores

  From parent study baseline to weeks 48, 96 and 144

Study Arms (1)

Lunsekimig

EXPERIMENTAL

Participants will receive subcutaneous injection of lunsekimig according to established dosing interval

Drug: Lunsekimig

Interventions

Lunsekimig DRUG

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

Also known as: SAR443765

Lunsekimig

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (127)

Chandler Clinical Research Trials- Site Number : 8400075

Chandler, Arizona, 85224, United States

Location

Tucson Clinical Research Institute- Site Number : 8400085

Tucson, Arizona, 85712, United States

Location

Allianz Research Institute - Aurora- Site Number : 8400026

Aurora, Colorado, 80014, United States

Location

Western States Clinical Research- Site Number : 8400014

Wheat Ridge, Colorado, 80033, United States

Location

Helix Biomedics- Site Number : 8400114

Boynton Beach, Florida, 33435, United States

Location

Beautiful Minds Clinical Research Center- Site Number : 8400049

Cutler Bay, Florida, 33157, United States

Location

Qway Research - Hialeah- Site Number : 8400015

Hialeah, Florida, 33010, United States

Location

Clintex Research Group - Miami - Southwest 27th Avenue- Site Number : 8400048

Miami, Florida, 33135, United States

Location

High Quality Research- Site Number : 8400039

Miami, Florida, 33184, United States

Location

Innovations Biotech- Site Number : 8400040

Miami, Florida, 33186, United States

Location

New Access Medical Center- Site Number : 8400043

Miami, Florida, 33186, United States

Location

Deluxe Health Center- Site Number : 8400045

Miami Lakes, Florida, 33014, United States

Location

Tellabio International Research Services- Site Number : 8400083

Pembroke Pines, Florida, 33025, United States

Location

Avanza Medical Research Center- Site Number : 8400135

Pensacola, Florida, 32503, United States

Location

Ilumina Medical Research- Site Number : 8400095

Saint Cloud, Florida, 34769, United States

Location

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

Sarasota, Florida, 34239, United States

Location

Brigham & Women's Hospital- Site Number : 8400034

Boston, Massachusetts, 02115, United States

Location

University of Michigan Health System - Ann Arbor- Site Number : 8400004

Ann Arbor, Michigan, 48109, United States

Location

Midwest Clinical Research Center - St. Louis- Site Number : 8400006

St Louis, Missouri, 63141, United States

Location

Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400029

Charlotte, North Carolina, 28287, United States

Location

Asthma & Allergy Center - Toledo- Site Number : 8400017

Toledo, Ohio, 43617, United States

Location

OK Clinical Research- Site Number : 8400021

Edmond, Oklahoma, 73034, United States

Location

Clinical Research Associates of Central Pennsylvania- Site Number : 8400116

DuBois, Pennsylvania, 15801, United States

Location

Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400007

Pittsburgh, Pennsylvania, 15241, United States

Location

Orion Clinical Research- Site Number : 8400001

Austin, Texas, 78759, United States

Location

South Texas Medical Research Institute - TTS Research- Site Number : 8400010

Boerne, Texas, 78006, United States

Location

Baylor University Medical Center- Site Number : 8400002

Dallas, Texas, 75246, United States

Location

Western Sky Medical Research- Site Number : 8400023

El Paso, Texas, 79903, United States

Location

Metroplex Pulmonary and Sleep Center- Site Number : 8400022

McKinney, Texas, 75069, United States

Location

Investigational Site Number : 0320007

Berazategui, Buenos Aires, 1886, Argentina

Location

Investigational Site Number : 0320003

La Plata, Buenos Aires, 1900, Argentina

Location

Investigational Site Number : 0320002

Rosario, Santa Fe Province, 2000, Argentina

Location

Investigational Site Number : 0320006

Rosario, Santa Fe Province, 2000, Argentina

Location

Investigational Site Number : 0320008

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Investigational Site Number : 0320005

Buenos Aires, 1121, Argentina

Location

Investigational Site Number : 0320012

Buenos Aires, 1122, Argentina

Location

Investigational Site Number : 0320004

Buenos Aires, 1414, Argentina

Location

Investigational Site Number : 0320001

Buenos Aires, 1425, Argentina

Location

Investigational Site Number : 0320011

Buenos Aires, 1425, Argentina

Location

Investigational Site Number : 0320009

Mendoza, 5500, Argentina

Location

Investigational Site Number : 0320015

Mendoza, 5500, Argentina

Location

Investigational Site Number : 0320010

Santa Fe, 3000, Argentina

Location

Associacao Proar- Site Number : 0760003

Salvador, Estado de Bahia, 40060-330, Brazil

Location

Universidade Federal de Goias- Site Number : 0760007

Goiânia, Goiás, 74605-020, Brazil

Location

Centro de Estudos em Terapias Inovadoras- Site Number : 0760002

Curitiba, Paraná, 80030-110, Brazil

Location

Instituto de Medicina Integral Professor Fernando Figueira- Site Number : 0760009

Recife, Pernambuco, 50070-550, Brazil

Location

Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Hospital Dia do Pulmão- Site Number : 0760005

Blumenau, Santa Catarina, 89030-101, Brazil

Location

CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760006

Rio de Janeiro, 22241-180, Brazil

Location

Incor - Instituto do Coracao- Site Number : 0760011

São Paulo, 05403-900, Brazil

Location

Investigational Site Number : 1240003

Hamilton, Ontario, L8N 4A6, Canada

Location

Investigational Site Number : 1240004

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Investigational Site Number : 1240001

Trois-Rivières, Quebec, G8T 7A1, Canada

Location

Investigational Site Number : 1520013

Concepción, Biobio, 4070094, Chile

Location

Investigational Site Number : 1520001

Talca, Maule Region, 3465584, Chile

Location

Investigational Site Number : 1520006

Santiago, Reg Metropolitana de Santiago, 7500587, Chile

Location

Investigational Site Number : 1520005

Santiago, Reg Metropolitana de Santiago, 7500692, Chile

Location

Investigational Site Number : 1520004

Santiago, Reg Metropolitana de Santiago, 7500698, Chile

Location

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, 7750495, Chile

Location

Investigational Site Number : 1520008

Quillota, Valparaiso, 2260877, Chile

Location

Investigational Site Number : 1520011

Viña del Mar, Valparaiso, 2531172, Chile

Location

Investigational Site Number : 1560011

Beijing, 100144, China

Location

Investigational Site Number : 1560010

Changchun, 130021, China

Location

Investigational Site Number : 1560017

Changsha, 410015, China

Location

Investigational Site Number : 1560053

Guangzhou, 510000, China

Location

Investigational Site Number : 1560009

Guangzhou, 510150, China

Location

Investigational Site Number : 1560001

Guangzhou, 510163, China

Location

Investigational Site Number : 1560006

Hefei, 230032, China

Location

Investigational Site Number : 1560014

Hohhot, 010050, China

Location

Investigational Site Number : 1560007

Nanchang, 330006, China

Location

Investigational Site Number : 1560002

Pingxiang, 337055, China

Location

Investigational Site Number : 1560013

Shanghai, 200433, China

Location

Investigational Site Number : 1560015

Shenyang, 110004, China

Location

Investigational Site Number : 1560057

Taiyuan, 030001, China

Location

Investigational Site Number : 1560005

Wenzhou, 325027, China

Location

Investigational Site Number : 1560003

Wuhan, 430030, China

Location

Investigational Site Number : 1560022

Wuhan, 430030, China

Location

Investigational Site Number : 1560004

Xuzhou, 221006, China

Location

Investigational Site Number : 1560016

Yangzhou, 225000, China

Location

Investigational Site Number : 1560012

Zhanjiang, 524004, China

Location

Investigational Site Number : 3560007

Calicut, 673008, India

Location

Investigational Site Number : 3560009

Hyderabad, 500084, India

Location

Investigational Site Number : 3560008

Kanpur, 208001, India

Location

Investigational Site Number : 3560001

Nagpur, 441203, India

Location

Investigational Site Number : 3560004

Pune, 411057, India

Location

Investigational Site Number : 3760006

Ashkelon, 7830604, Israel

Location

Investigational Site Number : 3760001

Haifa, 3104802, Israel

Location

Investigational Site Number : 3760008

Haifa, 3436212, Israel

Location

Investigational Site Number : 3760003

Jerusalem, 9103102, Israel

Location

Investigational Site Number : 3760002

Jerusalem, 9112001, Israel

Location

Investigational Site Number : 3760010

Petah Tikva, 4941492, Israel

Location

Investigational Site Number : 3760004

Rehovot, 7610001, Israel

Location

Investigational Site Number : 3760007

Tel Aviv, 6423906, Israel

Location

Investigational Site Number : 3920002

Sakaidechō, Kagawa-ken, 762-8550, Japan

Location

Investigational Site Number : 3920011

Chūō, Tokyo, 104-0031, Japan

Location

Investigational Site Number : 3920005

Ube, Yamaguchi, 755-8505, Japan

Location

Investigational Site Number : 3920008

Fukushima, 960-1295, Japan

Location

Investigational Site Number : 3920006

Kyoto, 610-0113, Japan

Location

Investigational Site Number : 3920009

Kyoto, 612-8555, Japan

Location

Investigational Site Number : 3920012

Miyazaki, 889-1692, Japan

Location

Investigational Site Number : 4840004

Monterrey, Nuevo León, 66465, Mexico

Location

Investigational Site Number : 4840005

San Juan del Río, Querétaro, 76800, Mexico

Location

Investigational Site Number : 4840007

Mérida, Yucatán, 97070, Mexico

Location

Investigational Site Number : 4840002

Chihuahua City, 31000, Mexico

Location

Investigational Site Number : 4840003

Durango, 34000, Mexico

Location

Investigational Site Number : 4840008

Veracruz, 91900, Mexico

Location

Investigational Site Number : 7100004

Benoni, 1500, South Africa

Location

Investigational Site Number : 7100005

Benoni, 1500, South Africa

Location

Investigational Site Number : 7100003

Cape Town, 7530, South Africa

Location

Investigational Site Number : 7100002

Cape Town, 7700, South Africa

Location

Investigational Site Number : 7100001

Durban, 4001, South Africa

Location

Investigational Site Number : 7100006

Pretoria, 0157, South Africa

Location

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi, 03080, South Korea

Location

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, 03722, South Korea

Location

Investigational Site Number : 4100004

Seoul, Seoul-teukbyeolsi, 05030, South Korea

Location

Investigational Site Number : 4100006

Seoul, Seoul-teukbyeolsi, 05505, South Korea

Location

Investigational Site Number : 4100005

Seoul, Seoul-teukbyeolsi, 06351, South Korea

Location

Investigational Site Number : 7920006

Bursa, 16059, Turkey (Türkiye)

Location

Investigational Site Number : 7920002

Istanbul, 34098, Turkey (Türkiye)

Location

Investigational Site Number : 7920003

Istanbul, 34854, Turkey (Türkiye)

Location

Investigational Site Number : 7920005

İzmit, 41001, Turkey (Türkiye)

Location

Investigational Site Number : 7920007

Kayseri, 38039, Turkey (Türkiye)

Location

Investigational Site Number : 7920001

Mersin, 33070, Turkey (Türkiye)

Location

Investigational Site Number : 8260001

Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

Location

Investigational Site Number : 8260004

Glasgow, Glasgow City, G12 0YN, United Kingdom

Location

Investigational Site Number : 8260005

Chertsey, Surrey, KT16 0PZ, United Kingdom

Location

Investigational Site Number : 8260008

Bradford, BD9 6RJ, United Kingdom

Location

Related Links

• LTS17231 Plain Language Results Summary

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

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: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

KR (5); US (29); JP (7); CL (8); BR (8); IL (8); ZA (6); CA (3); AR (13); ME (6); IN (5); TU (6); GB (4); CN (19)