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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Asthma
• Intervention / Treatment: Drug: Lunsekimig

Detailed Description

Enter Intervention Groups

• Study Type: Interventional
• Enrollment (Estimated): 900
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1121
    • Investigational Site Number : 0320005
  • Buenos Aires, Argentina, 1414
    • Investigational Site Number : 0320004
  • Buenos Aires, Argentina, 1425
    • Investigational Site Number : 0320001
  • Buenos Aires, Argentina, 1122
    • Investigational Site Number : 0320012
  • Buenos Aires, Argentina, 1425
    • Investigational Site Number : 0320011
  • Mendoza, Argentina, 5500
    • Investigational Site Number : 0320009
  • Santa Fe, Argentina, 3000
    • Investigational Site Number : 0320010
  • Buenos Aires
    • Berazategui, Buenos Aires, Argentina, 1886
      • Investigational Site Number : 0320007
    • La Plata, Buenos Aires, Argentina, 1900
      • Investigational Site Number : 0320003
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, 2000
      • Investigational Site Number : 0320002
    • Rosario, Santa Fe Province, Argentina, 2000
      • Investigational Site Number : 0320006
  • Tucumán Province
    • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
      • Investigational Site Number : 0320008
• Brazil
  • Rio de Janeiro, Brazil, 22241-180
    • CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760006
  • São Paulo, Brazil, 05403-900
    • Incor - Instituto do Coracao- Site Number : 0760011
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 40060-330
      • Associacao Proar- Site Number : 0760003
  • Goiás
    • Goiânia, Goiás, Brazil, 74605-020
      • Universidade Federal de Goias- Site Number : 0760007
  • Paraná
    • Curitiba, Paraná, Brazil, 80030-110
      • Centro de Estudos em Terapias Inovadoras- Site Number : 0760002
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50070-550
      • Instituto de Medicina Integral Professor Fernando Figueira- Site Number : 0760009
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001
  • Santa Catarina
    • Blumenau, Santa Catarina, Brazil, 89030-101
      • Hospital Dia do Pulmão- Site Number : 0760005
• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • Investigational Site Number : 1240003
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Investigational Site Number : 1240004
    • Trois-Rivières, Quebec, Canada, G8T 7A1
      • Investigational Site Number : 1240001
• Chile
  • Maule Region
    • Talca, Maule Region, Chile, 3465584
      • Investigational Site Number : 1520001
  • Reg Metropolitana de Santiago
    • Santiago, Reg Metropolitana de Santiago, Chile, 7500587
      • Investigational Site Number : 1520006
    • Santiago, Reg Metropolitana de Santiago, Chile, 7500692
      • Investigational Site Number : 1520005
    • Santiago, Reg Metropolitana de Santiago, Chile, 7500698
      • Investigational Site Number : 1520004
    • Santiago, Reg Metropolitana de Santiago, Chile, 7750495
      • Investigational Site Number : 1520002
  • Valparaiso
    • Quillota, Valparaiso, Chile, 2260877
      • Investigational Site Number : 1520008
    • Viña del Mar, Valparaiso, Chile, 2531172
      • Investigational Site Number : 1520011
• China
  • Beijing, China, 100144
    • Investigational Site Number : 1560011
  • Changchun, China, 130021
    • Investigational Site Number : 1560010
  • Changsha, China, 410015
    • Investigational Site Number : 1560017
  • Guangzhou, China, 510150
    • Investigational Site Number : 1560009
  • Guangzhou, China, 510000
    • Investigational Site Number : 1560053
  • Guangzhou, China, 510163
    • Investigational Site Number : 1560001
  • Hefei, China, 230032
    • Investigational Site Number : 1560006
  • Hohhot, China, 010050
    • Investigational Site Number : 1560014
  • Nanchang, China, 330006
    • Investigational Site Number : 1560007
  • Pingxiang, China, 337055
    • Investigational Site Number : 1560002
  • Shanghai, China, 200433
    • Investigational Site Number : 1560013
  • Shenyang, China, 110004
    • Investigational Site Number : 1560015
  • Wenzhou, China, 325027
    • Investigational Site Number : 1560005
  • Wuhan, China, 430030
    • Investigational Site Number : 1560003
  • Wuhan, China, 430030
    • Investigational Site Number : 1560022
  • Xuzhou, China, 221006
    • Investigational Site Number : 1560004
  • Yangzhou, China, 225000
    • Investigational Site Number : 1560016
  • Zhanjiang, China, 524004
    • Investigational Site Number : 1560012
• India
  • Calicut, India, 673008
    • Investigational Site Number : 3560007
  • Hyderabad, India, 500084
    • Investigational Site Number : 3560009
  • Kanpur, India, 208001
    • Investigational Site Number : 3560008
  • Nagpur, India, 441203
    • Investigational Site Number : 3560001
  • Pune, India, 411057
    • Investigational Site Number : 3560004
• Israel
  • Ashkelon, Israel, 7830604
    • Investigational Site Number : 3760006
  • Haifa, Israel, 3104802
    • Investigational Site Number : 3760001
  • Haifa, Israel, 3436212
    • Investigational Site Number : 3760008
  • Jerusalem, Israel, 9103102
    • Investigational Site Number : 3760003
  • Jerusalem, Israel, 9112001
    • Investigational Site Number : 3760002
  • Petah Tikva, Israel, 4941492
    • Investigational Site Number : 3760010
  • Rehovot, Israel, 7610001
    • Investigational Site Number : 3760004
  • Tel Aviv, Israel, 6423906
    • Investigational Site Number : 3760007
• Japan
  • Fukushima, Japan, 960-1295
    • Investigational Site Number : 3920008
  • Kyoto, Japan, 610-0113
    • Investigational Site Number : 3920006
  • Kyoto, Japan, 612-8555
    • Investigational Site Number : 3920009
  • Miyazaki, Japan, 889-1692
    • Investigational Site Number : 3920012
  • Kagawa-ken
    • Sakaidechō, Kagawa-ken, Japan, 762-8550
      • Investigational Site Number : 3920002
  • Tokyo
    • Chūō, Tokyo, Japan, 104-0031
      • Investigational Site Number : 3920011
  • Yamaguchi
    • Ube, Yamaguchi, Japan, 755-8505
      • Investigational Site Number : 3920005
• Mexico
  • Chihuahua City, Mexico, 31000
    • Investigational Site Number : 4840002
  • Durango, Mexico, 34000
    • Investigational Site Number : 4840003
  • Veracruz, Mexico, 91900
    • Investigational Site Number : 4840008
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 66465
      • Investigational Site Number : 4840004
  • Querétaro
    • San Juan del Río, Querétaro, Mexico, 76800
      • Investigational Site Number : 4840005
  • Yucatán
    • Mérida, Yucatán, Mexico, 97070
      • Investigational Site Number : 4840007
• South Africa
  • Benoni, South Africa, 1500
    • Investigational Site Number : 7100004
  • Benoni, South Africa, 1500
    • Investigational Site Number : 7100005
  • Cape Town, South Africa, 7530
    • Investigational Site Number : 7100003
  • Cape Town, South Africa, 7700
    • Investigational Site Number : 7100002
  • Durban, South Africa, 4001
    • Investigational Site Number : 7100001
  • Pretoria, South Africa, 0157
    • Investigational Site Number : 7100006
• South Korea
  • Seoul-teukbyeolsi
    • Seoul, Seoul-teukbyeolsi, South Korea, 03722
      • Investigational Site Number : 4100001
    • Seoul, Seoul-teukbyeolsi, South Korea, 03080
      • Investigational Site Number : 4100002
    • Seoul, Seoul-teukbyeolsi, South Korea, 05030
      • Investigational Site Number : 4100004
    • Seoul, Seoul-teukbyeolsi, South Korea, 05505
      • Investigational Site Number : 4100006
    • Seoul, Seoul-teukbyeolsi, South Korea, 06351
      • Investigational Site Number : 4100005
• Turkey (Türkiye)
  • Bursa, Turkey (Türkiye), 16059
    • Investigational Site Number : 7920006
  • Istanbul, Turkey (Türkiye), 34098
    • Investigational Site Number : 7920002
  • Istanbul, Turkey (Türkiye), 34854
    • Investigational Site Number : 7920003
  • Kayseri, Turkey (Türkiye), 38039
    • Investigational Site Number : 7920007
  • Mersin, Turkey (Türkiye), 33070
    • Investigational Site Number : 7920001
  • İzmit, Turkey (Türkiye), 41001
    • Investigational Site Number : 7920005
• United Kingdom
  • Bradford, United Kingdom, BD9 6RJ
    • Investigational Site Number : 8260008
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
      • Investigational Site Number : 8260001
  • Glasgow City
    • Glasgow, Glasgow City, United Kingdom, G12 0YN
      • Investigational Site Number : 8260004
  • Surrey
    • Chertsey, Surrey, United Kingdom, KT16 0PZ
      • Investigational Site Number : 8260005
• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Chandler Clinical Research Trials- Site Number : 8400075
    • Tucson, Arizona, United States, 85712
      • Tucson Clinical Research Institute- Site Number : 8400085
  • Colorado
    • Aurora, Colorado, United States, 80014
      • Allianz Research Institute - Aurora- Site Number : 8400026
    • Wheat Ridge, Colorado, United States, 80033
      • Western States Clinical Research- Site Number : 8400014
  • Florida
    • Boynton Beach, Florida, United States, 33435
      • Helix Biomedics- Site Number : 8400114
    • Cutler Bay, Florida, United States, 33157
      • Beautiful Minds Clinical Research Center- Site Number : 8400049
    • Hialeah, Florida, United States, 33010
      • Qway Research - Hialeah- Site Number : 8400015
    • Miami, Florida, United States, 33184
      • High Quality Research- Site Number : 8400039
    • Miami, Florida, United States, 33186
      • Innovations Biotech- Site Number : 8400040
    • Miami, Florida, United States, 33186
      • New Access Medical Center- Site Number : 8400043
    • Miami, Florida, United States, 33135
      • Clintex Research Group - Miami - Southwest 27th Avenue- Site Number : 8400048
    • Miami Lakes, Florida, United States, 33014
      • Deluxe Health Center- Site Number : 8400045
    • Pensacola, Florida, United States, 32503
      • Avanza Medical Research Center- Site Number : 8400135
    • Sarasota, Florida, United States, 34239
      • Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400019
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's Hospital- Site Number : 8400034
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System - Ann Arbor- Site Number : 8400004
  • Missouri
    • St Louis, Missouri, United States, 63141
      • Midwest Clinical Research Center - St. Louis- Site Number : 8400006
  • North Carolina
    • Charlotte, North Carolina, United States, 28287
      • Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400029
  • Ohio
    • Toledo, Ohio, United States, 43617
      • Asthma & Allergy Center - Toledo- Site Number : 8400017
  • Oklahoma
    • Edmond, Oklahoma, United States, 73034
      • OK Clinical Research- Site Number : 8400021
  • Pennsylvania
    • DuBois, Pennsylvania, United States, 15801
      • Clinical Research Associates of Central Pennsylvania- Site Number : 8400116
    • Pittsburgh, Pennsylvania, United States, 15241
      • Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400007
  • Texas
    • Austin, Texas, United States, 78759
      • Orion Clinical Research- Site Number : 8400001
    • Boerne, Texas, United States, 78006
      • South Texas Medical Research Institute - TTS Research- Site Number : 8400010
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center- Site Number : 8400002
    • El Paso, Texas, United States, 79903
      • Western Sky Medical Research- Site Number : 8400023
    • McKinney, Texas, United States, 75069
      • Metroplex Pulmonary and Sleep Center- Site Number : 8400022

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lunsekimig; Participants will receive subcutaneous injection of lunsekimig according to established dosing interval	Drug: Lunsekimig; Pharmaceutical form: Solution for injection in vial; Route of administration: Subcutaneous injection; Other Names: SAR443765

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The ACQ-5 is a questionnaire that measures the adequacy of asthma control and any changes in asthma control that may occur spontaneously or as a result of treatment. The ACQ-5 has five questions on the asthma symptoms and patients are asked to recall how their asthma has been during the previous week and to respond on a 7-point scale for each question (0 = no impairment, 6 = maximum impairment). The ACQ-5 score is the mean of the 5 questions and, therefore, between 0 (totally controlled) and 6 (severely uncontrolled). A high score indicates low asthma control.	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	Defined as ACQ-5 responder analysis	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	The AQLQ(S) + 12 was designed as a self-administered patient reported outcome to measure the functional impairments that are most troublesome to adolescents and adults ≥12 years of age as a result of their asthma. The instrument is comprised of 32 items, each rated on a 7-point Likert scales from 1 to 7. Higher scores indicate better quality of life.	From parent study baseline to weeks 48, 96 and 144
Serum lunsekimig concentrations		From study baseline to week 144
Incidence and titer of anti-drug antibodies (ADA) against lunsekimig		From study baseline to week 144

Collaborators and Investigators

• Sponsor: Sanofi

Publications and helpful links

Helpful Links

• LTS17231 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2024
• Primary Completion (Estimated): January 20, 2031
• Study Completion (Estimated): January 20, 2031

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: LTS17231 (Sanofi Identifier); 2025-522896-27 (Registry Identifier: CTIS); U1111-1303-3645 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No