Dose Ranging Study of Lunsekimig Compared With Placebo-control in Adult Participants With Moderate-to-severe Asthma (AIRCULES)

March 16, 2026 updated by: Sanofi

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose Ranging Study to Assess the Efficacy, Safety, and Tolerability of Subcutaneous Lunsekimig in Adult Participants With Moderate-to-severe Asthma

This is a Phase 2b, global, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the efficacy, safety, and tolerability of add-on therapy with SC lunsekimig in adult participants aged 18 to 80 years, (inclusive) with moderate-to-severe asthma.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
685

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial Transparency email recommended (Toll free number for US and Canada)
  • Phone Number: option 6 800-633-1610
  • Email: contact-us@sanofi.com

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
      • Mendoza, Argentina, 5500
        • Investigational Site Number : 0320009
      • San Miguel de Tucumán, Argentina, 4000
        • Investigational Site Number : 0320008
      • 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
  • 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
        • Inst 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
      • Stoney Creek, Ontario, Canada, L8G 2V6
        • Investigational Site Number : 1240005
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Investigational Site Number : 1240004
      • Trois-Rivières, Quebec, Canada, G8T 7A1
        • Investigational Site Number : 1240001
  • Chile
    • Los Ríos Region
      • Valdivia, Los Ríos Region, Chile, 5110683
        • Investigational Site Number : 1520010
    • 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, 7580206
        • Investigational Site Number : 1520009
      • Santiago, Reg Metropolitana de Santiago, Chile, 7750495
        • Investigational Site Number : 1520002
    • Región de Valparaíso
      • Quillota, Región de Valparaíso, Chile, 2260877
        • Investigational Site Number : 1520008
      • Viña del Mar, Región de Valparaíso, Chile, 2520598
        • 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
      • Chengdu, China, 610041
        • Investigational Site Number : 1560008
      • Guangzhou, China, 510120
        • Investigational Site Number : 1560001
      • Guangzhou, China, 510150
        • Investigational Site Number : 1560009
      • Hefei, China, 230032
        • Investigational Site Number : 1560006
      • Hohhot, China, 010050
        • Investigational Site Number : 1560014
      • Mianyang, China, 621000
        • Investigational Site Number : 1560018
      • 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
      • Xuzhou, China, 221006
        • Investigational Site Number : 1560004
      • Yangzhou, China, 225000
        • Investigational Site Number : 1560016
      • Zhanjiang, China, 524004
        • Investigational Site Number : 1560012
  • India
      • Coimbatore, India, 641028
        • Investigational Site Number : 3560002
      • Delhi, India, 110 029
        • Investigational Site Number : 3560006
      • Hyderabad, India, 500084
        • Investigational Site Number : 3560009
      • Kanpur, India, 208002
        • Investigational Site Number : 3560008
      • Kozhikode, India, 673008
        • Investigational Site Number : 3560007
      • Lucknow, India, 226006
        • Investigational Site Number : 3560003
      • 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
      • Ramat Gan, Israel, 5262100
        • Investigational Site Number : 3760009
      • Rehovot, Israel, 7610001
        • Investigational Site Number : 3760004
      • Tel Aviv, Israel, 6423906
        • Investigational Site Number : 3760007
  • Japan
      • Fukushima, Japan, 960-1295
        • Investigational Site Number : 3920008
      • Higashiōmi, Japan, 527-8505
        • Investigational Site Number : 3920003
      • Kyoto, Japan, 610-0113
        • Investigational Site Number : 3920006
      • Kyoto, Japan, 612-8555
        • Investigational Site Number : 3920009
      • Miyazaki, Japan, 889-1692
        • Investigational Site Number : 3920012
    • Chiba
      • Kamogawa, Chiba, Japan, 296-0041
        • Investigational Site Number : 3920004
    • Kagawa-ken
      • Sakaidechō, Kagawa-ken, Japan, 762-8550
        • Investigational Site Number : 3920002
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 231-0801
        • Investigational Site Number : 3920010
    • 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
      • Mérida, Mexico, 97070
        • Investigational Site Number : 4840007
      • Veracruz, Mexico, 91910
        • Investigational Site Number : 4840008
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44100
        • Investigational Site Number : 4840001
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 66465
        • Investigational Site Number : 4840004
    • Querétaro
      • San Juan del Río, Querétaro, Mexico, 76800
        • Investigational Site Number : 4840005
  • 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
      • Lochner ROAD, South Africa, PRETORIA
        • Investigational Site Number : 7100006
  • South Korea
      • Seoul, South Korea, 06351
        • Investigational Site Number : 4100005
    • 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, 08308
        • Investigational Site Number : 4100003
  • Turkey (Türkiye)
      • Akdeniz, Turkey (Türkiye), 33070
        • Investigational Site Number : 7920001
      • Bursa, Turkey (Türkiye), 16059
        • Investigational Site Number : 7920006
      • Istanbul, Turkey (Türkiye), 34098
        • Investigational Site Number : 7920002
      • Istanbul, Turkey (Türkiye), 34854
        • Investigational Site Number : 7920003
      • Izmir, Turkey (Türkiye), 35110
        • Investigational Site Number : 7920004
      • Kayseri, Turkey (Türkiye), 38039
        • Investigational Site Number : 7920007
      • İzmit, Turkey (Türkiye), 41001
        • Investigational Site Number : 7920005
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Investigational Site Number : 8260003
      • Bradford, United Kingdom, BD9 6RJ
        • Investigational Site Number : 8260008
      • Bristol, United Kingdom, BS8 2RA
        • Investigational Site Number : 8260009
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
        • Investigational Site Number : 8260001
    • Edinburgh, City of
      • Glasgow, Edinburgh, City of, United Kingdom, G12 0YN
        • Investigational Site Number : 8260004
    • Surrey
      • Chertsey, Surrey, United Kingdom, KT16 0PZ
        • Investigational Site Number : 8260005
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Allergy, Asthma & Immunology Associates- Site Number : 8400009
      • Yuma, Arizona, United States, 85364
        • Yuma Pulmonary & Sleep Research, LLC- Site Number : 8400072
    • California
      • Lancaster, California, United States, 93534
        • Antelope Valley Clinical Trials- Site Number : 8400020
      • Northridge, California, United States, 91324
        • Amicis Research Center - Northridge - Nordhoff Street- Site Number : 8400032
      • San Francisco, California, United States, 94102
        • Optimus Medical- Site Number : 8400046
      • San Jose, California, United States, 95117
        • Allergy and Asthma Associates of Santa Clara Valley Research Center- Site Number : 8400038
      • Thousand Oaks, California, United States, 91360
        • Clinical Trials Management Services - Thousand Oaks- Site Number : 8400053
    • Colorado
      • Aurora, Colorado, United States, 80014
        • Allianz Research Institute CO- Site Number : 8400026
      • Englewood, Colorado, United States, 80110
        • Velocity Clinical Research - Denver- Site Number : 8400027
      • Wheat Ridge, Colorado, United States, 80033
        • Western States Clinical Research- Site Number : 8400014
    • Florida
      • 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, 33145
        • Clintex Research Group - Miami - Coral Way- Site Number : 8400048
      • 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 Lakes, Florida, United States, 33014
        • Deluxe Health Center- Site Number : 8400045
      • New Port Richey, Florida, United States, 34653
        • Advanced Research Institute - New Port Richey- Site Number : 8400044
      • Pembroke Pines, Florida, United States, 33024
        • Pines Care Research Center- Site Number : 8400057
      • Sarasota, Florida, United States, 34239
        • Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400019
    • Georgia
      • Calhoun, Georgia, United States, 30701
        • Appalachian Clinical Research- Site Number : 8400050
    • Illinois
      • Champaign, Illinois, United States, 61822
        • PMG Research of Christie Clinic- Site Number : 8400066
    • Louisiana
      • Lafayette, Louisiana, United States, 70508
        • Velocity Clinical Research Lafayette Site Number : 8400060
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Javara - Privia Medical Group - Annapolis- Site Number : 8400033
    • 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
    • Minnesota
      • Mankato, Minnesota, United States, 56001
        • Javara - Mankato Clinic- Site Number : 8400051
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Midwest Clinical Research Center - St. Louis- Site Number : 8400006
    • New York
      • Middletown, New York, United States, 10940
        • Circuit Clinical - Middletown Medical - 111 Maltese Drive- Site Number : 8400065
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai- Site Number : 8400058
    • North Carolina
      • Charlotte, North Carolina, United States, 28273
        • Carolina Clinical Research - Charlotte- Site Number : 8400071
      • Charlotte, North Carolina, United States, 28287
        • Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400029
      • Gastonia, North Carolina, United States, 28054
        • Clinical Research Of Gastonia- Site Number : 8400013
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • Bernstein Clinical Research Center- Site Number : 8400016
      • Toledo, Ohio, United States, 43617
        • Asthma & Allergy Center - Toledo- Site Number : 8400017
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • OK Clinical Research- Site Number : 8400021
    • Oregon
      • Medford, Oregon, United States, 97504
        • Velocity Clinical Research - Medford- Site Number : 8400059
    • Pennsylvania
      • DuBois, Pennsylvania, United States, 15801
        • Clinical Research Associates of Central PA - Dubois- Site Number : 8400069
      • Pittsburgh, Pennsylvania, United States, 15241
        • Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400007
      • Pottstown, Pennsylvania, United States, 19464
        • Circuit Clinical - PMSI Comprehensive Healthcare for Life - Pottstown - Medical Drive- Site Number : 8400064
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • VitaLink Research - Anderson - East Greenville- Site Number : 8400063
      • Charleston, South Carolina, United States, 29414
        • Velocity Clinical Research - Charleston- Site Number : 8400061
    • 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
      • Plano, Texas, United States, 75093
        • VAST Clinical Research- Site Number : 8400062

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • A physician-diagnosed moderate-to-severe asthma for ≥12 months based on GINA guidelines Steps 4 and 5
  • Participants with existing treatment with moderate-to-high doses of ICS therapy for in combination with at least 1 but no more than 2 additional controller medications at least 3 months with a stable dose ≥1 month prior to Visit 1
  • At least 1 asthma exacerbation in the past year, with at least one exacerbation occurring while on treatment with moderate to high doses of ICS therapy
  • ACQ-5 score more than 1.5 at Screening (Visit 1)

Exclusion Criteria:

  • Chronic obstructive or other lung diseases (eg, COPD, idiopathic pulmonary fibrosis, etc) which may impair lung function, or another diagnosed pulmonary or systemic disease.
  • Current smoker or former smoker with cessation within 6 months of Screening or history of >10 pack-years. Active vaping of any products and/or marijuana smoking within 6 months of Screening.
  • Participants who experience a deterioration of asthma that results in emergency treatment or hospitalization, or treatment with systemic steroids within 1 month prior to the Screening
  • Participants who have experienced an upper or lower respiratory tract infection within the 4 weeks prior to Screening
  • For participants on chronic OCS use for the maintenance treatment of asthma: history of a serious infection requiring hospitalization within the past 12 months prior to Randomization (Visit 2).
  • Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening
  • Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Participants will receive placebo (subcutaneous injection) according to established dosing intervals corresponding to Dose 1 and Dose 2
Drug: Placebo
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Experimental: Lunsekimig Dose1 interval 1
Participants will receive Dose 1 of lunsekimig (subcutaneous injection) according to established dosing interval 1
Drug: Lunsekimig
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Experimental: Lunsekimig Dose 1 interval 2
Participants will receive Dose 1 of lunsekimig (subcutaneous injection) according to established dosing interval 2
Drug: Lunsekimig
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Experimental: Lunsekimig Dose 2 interval 1
Participants will receive Dose 2 of lunsekimig (subcutaneous injection) according to established dosing interval 1
Drug: Lunsekimig
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Experimental: Lunsekimig Dose 2 interval 2
Participants will receive Dose 2 of lunsekimig (subcutaneous injection) according to established dosing interval 2
Drug: Lunsekimig
Pharmaceutical form: solution for injection Route of administration: subcutaneous

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Annualized rate of asthma exacerbation events
Time Frame: From baseline to week 48
From baseline to week 48

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in pre-bronchodilator (BD) FEV1
Time Frame: From baseline to week 48
From baseline to week 48
Change from baseline in post-BD FEV1
Time Frame: From baseline to week 48
From baseline to week 48
The absolute change in the percent predicted FEV1 from baseline (pre-BD and post-BD)
Time Frame: From baseline to week 48
From baseline to week 48
Proportion of participants with ≥ 0.5-point reduction in ACQ-5 score
Time Frame: From baseline to week 48
ACQ-5 is Asthma control questionnaire assessing symptoms. Lower score shows better asthma control
From baseline to week 48
Change from baseline in ACQ-5 score
Time Frame: From baseline to week 48
From baseline to week 48
Change from baseline in FeNO
Time Frame: From baseline to week 48
From baseline to week 48
Time to first asthma exacerbation
Time Frame: From baseline to week 48
From baseline to week 48
Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit
Time Frame: From baseline to week 48
From baseline to week 48
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) scores
Time Frame: From baseline to week 48
Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.
From baseline to week 48
Change from baseline in ACQ scores
Time Frame: From baseline to week 48
From baseline to week 48
Average number of inhalations per day of short-acting beta 2-agoinst (SABA), Low dose ICS/formoterol or ICS/SABA for symptom relief
Time Frame: From baseline to week 48
From baseline to week 48
Proportion of participants with ≥4-point improvement in SGRQ score
Time Frame: From baseline to week 48
From baseline to week 48
Change from baseline in Asthma Quality of Life Questionnaire Standardized for 12 years and older (AQLQ{S} +12) scores
Time Frame: From baseline to week 48
From baseline to week 48
Proportion of participants with ≥0.5-point improvement in AQLQ(S)+12 domain and total scores
Time Frame: From baseline to week 48
From baseline to week 48
Proportion of participants with ≥0.5-point reduction in ACQ-6 and ACQ-7 score
Time Frame: From baseline to week 48
From baseline to week 48
Serum lunsekimig concentrations
Time Frame: From baseline to week 52
From baseline to week 52
Anti-drug antibodies (ADA) against lunsekimig
Time Frame: From baseline to week 52
From baseline to week 52
Incidence of participants with treatment-emergent adverse events (TEAEs), including local reactions, adverse events of special interests (AESIs), serious adverse events (SAEs)
Time Frame: From baseline to week 52
From baseline to week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinial Science & Operations, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 16, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 23, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 11, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DRI16762
  • U1111-1280-5514 (Other Identifier: WHO)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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