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AsthmaPhase 2AIRPHRODITENCT06609239

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

A Phase 2 study testing Lunsekimig in people with Asthma, run by Sanofi at 150 sites in 20 countries.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
What is being tested?
Lunsekimig
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
900 participants
Where
150 sitesin 20 countries
Study dates
30 Sep 2024to 20 Jan 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 13Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

150 sites in 20 countries. Contact the study team or a site near you to ask about taking part.

150 sites in 20 countries

United States31 sites

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

    Ann Arbor, Michigan, 48109

  • Allianz Research Institute - Aurora- Site Number : 8400026

    Aurora, Colorado, 80014

  • Orion Clinical Research- Site Number : 8400001

    Austin, Texas, 78759

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

    Boerne, Texas, 78006

  • Brigham & Women's Hospital- Site Number : 8400034

    Boston, Massachusetts, 02115

  • Helix Biomedics- Site Number : 8400114

    Boynton Beach, Florida, 33435

  • Chandler Clinical Research Trials- Site Number : 8400075

    Chandler, Arizona, 85224

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

    Charlotte, North Carolina, 28287

  • Private Practice - Dr. David Kavtaradze- Site Number : 8400081

    Cordele, Georgia, 31015

  • Beautiful Minds Clinical Research Center- Site Number : 8400049

    Cutler Bay, Florida, 33157

  • Baylor University Medical Center- Site Number : 8400002

    Dallas, Texas, 75246

  • Clinical Research Associates of Central Pennsylvania- Site Number : 8400116

    DuBois, Pennsylvania, 15801

  • OK Clinical Research- Site Number : 8400021

    Edmond, Oklahoma, 73034

  • Western Sky Medical Research- Site Number : 8400023

    El Paso, Texas, 79903

  • Qway Research - Hialeah- Site Number : 8400015

    Hialeah, Florida, 33010

  • Metroplex Pulmonary and Sleep Center- Site Number : 8400022

    McKinney, Texas, 75069

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

    Miami, Florida, 33135

  • High Quality Research- Site Number : 8400039

    Miami, Florida, 33184

  • Innovations Biotech- Site Number : 8400040

    Miami, Florida, 33186

  • New Access Medical Center- Site Number : 8400043

    Miami, Florida, 33186

  • Deluxe Health Center- Site Number : 8400045

    Miami Lakes, Florida, 33014

  • Tellabio International Research Services- Site Number : 8400083

    Pembroke Pines, Florida, 33025

  • Alfa Medical Research LLC- Site Number : 8400146

    Pembroke Pines, Florida, 33029

  • Avanza Medical Research Center- Site Number : 8400135

    Pensacola, Florida, 32503

  • Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400007

    Pittsburgh, Pennsylvania, 15241

  • Ilumina Medical Research- Site Number : 8400095

    Saint Cloud, Florida, 34769

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

    Sarasota, Florida, 34239

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

    St Louis, Missouri, 63141

  • Asthma & Allergy Center - Toledo- Site Number : 8400017

    Toledo, Ohio, 43617

  • Tucson Clinical Research Institute- Site Number : 8400085

    Tucson, Arizona, 85712

  • Western States Clinical Research- Site Number : 8400014

    Wheat Ridge, Colorado, 80033

Other trials in United States

China23 sites

  • Investigational Site Number : 1560011

    Beijing, 100144

  • Investigational Site Number : 1560010

    Changchun, 130021

  • Investigational Site Number : 1560017

    Changsha, 410015

  • Investigational Site Number : 1560021

    Chengde, 067020

  • Investigational Site Number : 1560053

    Guangzhou, 510000

  • Investigational Site Number : 1560009

    Guangzhou, 510150

  • Investigational Site Number : 1560001

    Guangzhou, 510163

  • Investigational Site Number : 1560037

    Guiyang, 550002

  • Investigational Site Number : 1560006

    Hefei, 230032

  • Investigational Site Number : 1560014

    Hohhot, 010050

  • Investigational Site Number : 1560030

    Lanzhou, 730000

  • Investigational Site Number : 1560007

    Nanchang, 330006

  • Investigational Site Number : 1560002

    Pingxiang, 337055

  • Investigational Site Number : 1560013

    Shanghai, 200433

  • Investigational Site Number : 1560015

    Shenyang, 110004

  • Investigational Site Number : 1560057

    Taiyuan, 030001

  • Investigational Site Number : 1560055

    Tianjin, 300211

  • Investigational Site Number : 1560005

    Wenzhou, 325027

  • Investigational Site Number : 1560003

    Wuhan, 430030

  • Investigational Site Number : 1560022

    Wuhan, 430030

  • Investigational Site Number : 1560004

    Xuzhou, 221006

  • Investigational Site Number : 1560016

    Yangzhou, 225000

  • Investigational Site Number : 1560012

    Zhanjiang, 524004

Other trials in China

Argentina15 sites

  • Investigational Site Number : 0320007

    Berazategui, Buenos Aires, 1886

  • Investigational Site Number : 0320005

    Buenos Aires, 1121

  • Investigational Site Number : 0320012

    Buenos Aires, 1122

  • Investigational Site Number : 0320004

    Buenos Aires, 1414

  • Investigational Site Number : 0320001

    Buenos Aires, 1425

  • Investigational Site Number : 0320011

    Buenos Aires, 1425

  • Investigational Site Number : 0320003

    La Plata, Buenos Aires, B1904CUL

  • Investigational Site Number : 0320013

    Lobos, Buenos Aires, 7240

  • Investigational Site Number : 0320009

    Mendoza, 5500

  • Investigational Site Number : 0320015

    Mendoza, 5500

  • Investigational Site Number : 0320002

    Rosario, Santa Fe Province, 2000

  • Investigational Site Number : 0320006

    Rosario, Santa Fe Province, 2000

  • Investigational Site Number : 0320020

    Rosario, Santa Fe Province, 2000

  • Investigational Site Number : 0320008

    San Miguel de Tucumán, Tucumán Province, 4000

  • Investigational Site Number : 0320010

    Santa Fe, 3000

Other trials in Argentina

Chile10 sites

  • Investigational Site Number : 1520013

    Concepción, Biobio, 4070094

  • Investigational Site Number : 1520008

    Quillota, Valparaiso, 2260877

  • Investigational Site Number : 1520015

    Recoleta, Reg Metropolitana de Santiago, 8420000

  • Investigational Site Number : 1520006

    Santiago, Reg Metropolitana de Santiago, 7500587

  • Investigational Site Number : 1520005

    Santiago, Reg Metropolitana de Santiago, 7500692

  • Investigational Site Number : 1520004

    Santiago, Reg Metropolitana de Santiago, 7500698

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 7750495

  • Investigational Site Number : 1520001

    Talca, Maule Region, 3465584

  • Investigational Site Number : 1520011

    Viña del Mar, Valparaiso, 2531172

  • Investigational Site Number : 1520012

    Viña del Mar, Valparaiso, 2540364

Other trials in Chile

Brazil8 sites

  • Hospital Dia do Pulmão- Site Number : 0760005

    Blumenau, Santa Catarina, 89030-101

  • CETI - Centro de Estudos em Terapias Inovadoras- Site Number : 0760002

    Curitiba, Paraná, 80030-110

  • Universidade Federal de Goias- Site Number : 0760007

    Goiânia, Goiás, 74605-020

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

    Porto Alegre, Rio Grande do Sul, 90610-000

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

    Recife, Pernambuco, 50070-550

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

    Rio de Janeiro, 22241-180

  • Associacao Proar- Site Number : 0760003

    Salvador, Estado de Bahia, 40060-330

  • Incor - Instituto do Coracao- Site Number : 0760011

    São Paulo, 05403-000

Other trials in Brazil

Israel8 sites

  • Investigational Site Number : 3760006

    Ashkelon, 7830604

  • Investigational Site Number : 3760001

    Haifa, 3104802

  • Investigational Site Number : 3760008

    Haifa, 3436212

  • Investigational Site Number : 3760003

    Jerusalem, 9103102

  • Investigational Site Number : 3760002

    Jerusalem, 9112001

  • Investigational Site Number : 3760010

    Petah Tikva, 4941492

  • Investigational Site Number : 3760004

    Rehovot, 7610001

  • Investigational Site Number : 3760007

    Tel Aviv, 6423906

Other trials in Israel

Japan7 sites

  • Investigational Site Number : 3920011

    Chūō, Tokyo, 104-0031

  • Investigational Site Number : 3920008

    Fukushima, 960-1295

  • Investigational Site Number : 3920006

    Kyoto, 610-0113

  • Investigational Site Number : 3920009

    Kyoto, 612-8555

  • Investigational Site Number : 3920012

    Miyazaki, 889-1692

  • Investigational Site Number : 3920002

    Sakaidechō, Kagawa-ken, 762-8550

  • Investigational Site Number : 3920005

    Ube, Yamaguchi, 755-8505

Other trials in Japan

Turkey (Türkiye)7 sites

  • Investigational Site Number : 7920006

    Bursa, 16059

  • Investigational Site Number : 7920002

    Istanbul, 34098

  • Investigational Site Number : 7920003

    Istanbul, 34854

  • Investigational Site Number : 7920005

    İzmit, 41001

  • Investigational Site Number : 7920007

    Kayseri, 38039

  • Investigational Site Number : 7920008

    Kirikkale, 71100

  • Investigational Site Number : 7920001

    Mersin, 33070

Other trials in Turkey (Türkiye)

Mexico6 sites

  • Investigational Site Number : 4840002

    Chihuahua City, 31000

  • Investigational Site Number : 4840003

    Durango, 34000

  • Investigational Site Number : 4840007

    Mérida, Yucatán, 97070

  • Investigational Site Number : 4840004

    Monterrey, Nuevo León, 66465

  • Investigational Site Number : 4840005

    San Juan del Río, Querétaro, 76800

  • Investigational Site Number : 4840008

    Veracruz, 91900

Other trials in Mexico

South Africa6 sites

  • Investigational Site Number : 7100004

    Benoni, 1500

  • Investigational Site Number : 7100005

    Benoni, 1500

  • Investigational Site Number : 7100003

    Cape Town, 7530

  • Investigational Site Number : 7100002

    Cape Town, 7700

  • Investigational Site Number : 7100001

    Durban, 4001

  • Investigational Site Number : 7100006

    Pretoria, 0157

Other trials in South Africa

India5 sites

  • Investigational Site Number : 3560007

    Calicut, 673008

  • Investigational Site Number : 3560009

    Hyderabad, 500084

  • Investigational Site Number : 3560008

    Kanpur, 208001

  • Investigational Site Number : 3560001

    Nagpur, 441203

  • Investigational Site Number : 3560004

    Pune, 411057

Other trials in India

South Korea5 sites

  • Investigational Site Number : 4100002

    Seoul, Seoul-teukbyeolsi, 03080

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi, 03722

  • Investigational Site Number : 4100004

    Seoul, Seoul-teukbyeolsi, 05030

  • Investigational Site Number : 4100006

    Seoul, Seoul-teukbyeolsi, 05505

  • Investigational Site Number : 4100005

    Seoul, Seoul-teukbyeolsi, 06351

Other trials in South Korea

United Kingdom5 sites

  • Investigational Site Number : 8260008

    Bradford, BD9 6DA

  • Investigational Site Number : 8260001

    Cambridge, Cambridgeshire, CB2 2QQ

  • Investigational Site Number : 8260005

    Chertsey

  • Investigational Site Number : 8260004

    Glasgow, Glasgow City, G12 0YN

  • Investigational Site Number : 8260011

    London, W1G 8HU

Other trials in United Kingdom

Canada4 sites

  • Investigational Site Number : 1240013

    Ajax, Ontario, L1S 2J5

  • Investigational Site Number : 1240003

    Hamilton, Ontario, L8N 4A6

  • Investigational Site Number : 1240004

    Sherbrooke, Quebec, J1H 5N4

  • Investigational Site Number : 1240001

    Trois-Rivières, Quebec, G8T 7A1

Other trials in Canada

Spain3 sites

  • Investigational Site Number : 7240009

    Barcelona, Catalunya [Cataluña], 08017

  • Investigational Site Number : 7240008

    Madrid, 28007

  • Investigational Site Number : 7240011

    Madrid, 28010

Other trials in Spain

Germany2 sites

  • Investigational Site Number : 2760001

    Leipzig, 04347

  • Investigational Site Number : 2760005

    Mainz, 55128

Other trials in Germany

Poland2 sites

  • Investigational Site Number : 6160004

    Chęciny, 26-060

  • Investigational Site Number : 6160001

    Poznan, Greater Poland Voivodeship, 60-693

Other trials in Poland

Hungary1 site

  • Investigational Site Number : 3480004

    Mosonmagyaróvár, 9200

Other trials in Hungary

Italy1 site

  • Investigational Site Number : 3800010

    Rome, Roma, 00168

Other trials in Italy

Taiwan1 site

  • Investigational Site Number : 1580003

    Taipei, 110

Other trials in Taiwan

About this study

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

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
Being tested
Lunsekimig
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LunsekimigDrug

    Also called SAR443765

    • Pharmaceutical form: Solution for injection in vial or pre-filled syringe (PFS)
    • Route of administration: Subcutaneous injection
Study groups in NCT06609239
Study groupRoleWhat they receive
LunsekimigExperimentalParticipants will receive subcutaneous injection of lunsekimig according to established dosing interval
Receives: Drug: Lunsekimig

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From study baseline to week 148

Secondary outcomes (7)

  1. Annualized rate of asthma exacerbation events

    Measured: From study baseline to weeks 48, 96 and 144

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

    Measured: From parent study baseline to weeks 48, 96 and 144

  3. 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.

    Measured: From parent study baseline to weeks 48, 96 and 144

  4. 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

    Measured: From parent study baseline to weeks 48, 96 and 144

  5. 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.

    Measured: From parent study baseline to weeks 48, 96 and 144

  6. Serum lunsekimig concentrations

    Measured: From study baseline to week 144

  7. Incidence and titer of anti-drug antibodies (ADA) against lunsekimig

    Measured: From study baseline to week 144

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2024
  2. Study start30 Sep 2024
  3. Primary completion20 Jan 2031 (estimated)
  4. Study completion20 Jan 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06609239
Sponsor's protocol ID
LTS17231
Other IDs
2025-522896-27, U1111-1303-3645, 2025
Acronym
AIRPHRODITE
Status last verified
Sep 2026
First submitted
20 Sep 2024
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lunsekimig in people with Asthma, run by Sanofi at 150 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 150 sites in United States, China, Argentina, Chile, Brazil and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Exposure-adjusted incidence rate of treatment-emergent adverse event (TEAE), including adverse events of special interest (AESI), and serious adverse event (SAE) (time frame: From study baseline to week 148). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06609239.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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