AsthmaPhase 2AIRCULESNCT06102005
Dose Ranging Study of Lunsekimig Compared With Placebo-control in Adult Participants With Moderate-to-severe Asthma
A Phase 2 study testing Lunsekimig in people with Asthma, run by Sanofi at 156 sites in 14 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- Lunsekimig
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 685 participants
- Where
- 156 sitesin 14 countries
- Study dates
- 16 Oct 2023to 11 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
156 sites in 14 countries.
156 sites in 14 countries
United States48 sites
VitaLink Research - Anderson - East Greenville- Site Number : 8400063
Anderson, South Carolina, 29621
University of Michigan Health System - Ann Arbor- Site Number : 8400004
Ann Arbor, Michigan, 48109
Javara - Privia Medical Group - Annapolis- Site Number : 8400033
Annapolis, Maryland, 21401
Allianz Research Institute CO- 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
Appalachian Clinical Research- Site Number : 8400050
Calhoun, Georgia, 30701
PMG Research of Christie Clinic- Site Number : 8400066
Champaign, Illinois, 61822
Velocity Clinical Research - Charleston- Site Number : 8400061
Charleston, South Carolina, 29414
Carolina Clinical Research - Charlotte- Site Number : 8400071
Charlotte, North Carolina, 28273
Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400029
Charlotte, North Carolina, 28287
Bernstein Clinical Research Center- Site Number : 8400016
Cincinnati, Ohio, 45231
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 PA - Dubois- Site Number : 8400069
DuBois, Pennsylvania, 15801
OK Clinical Research- Site Number : 8400021
Edmond, Oklahoma, 73034
Western Sky Medical Research- Site Number : 8400023
El Paso, Texas, 79903
Velocity Clinical Research - Denver- Site Number : 8400027
Englewood, Colorado, 80110
Clinical Research Of Gastonia- Site Number : 8400013
Gastonia, North Carolina, 28054
Qway Research - Hialeah- Site Number : 8400015
Hialeah, Florida, 33010
Velocity Clinical Research Lafayette Site Number : 8400060
Lafayette, Louisiana, 70508
Antelope Valley Clinical Trials- Site Number : 8400020
Lancaster, California, 93534
Javara - Mankato Clinic- Site Number : 8400051
Mankato, Minnesota, 56001
Metroplex Pulmonary and Sleep Center- Site Number : 8400022
McKinney, Texas, 75069
Velocity Clinical Research - Medford- Site Number : 8400059
Medford, Oregon, 97504
Clintex Research Group - Miami - Coral Way- Site Number : 8400048
Miami, Florida, 33145
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
Circuit Clinical - Middletown Medical - 111 Maltese Drive- Site Number : 8400065
Middletown, New York, 10940
Advanced Research Institute - New Port Richey- Site Number : 8400044
New Port Richey, Florida, 34653
Icahn School of Medicine at Mount Sinai- Site Number : 8400058
New York, New York, 10029
Amicis Research Center - Northridge - Nordhoff Street- Site Number : 8400032
Northridge, California, 91324
Pines Care Research Center- Site Number : 8400057
Pembroke Pines, Florida, 33024
Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400007
Pittsburgh, Pennsylvania, 15241
VAST Clinical Research- Site Number : 8400062
Plano, Texas, 75093
Circuit Clinical - PMSI Comprehensive Healthcare for Life - Pottstown - Medical Drive- Site Number : 8400064
Pottstown, Pennsylvania, 19464
Optimus Medical- Site Number : 8400046
San Francisco, California, 94102
Allergy and Asthma Associates of Santa Clara Valley Research Center- Site Number : 8400038
San Jose, California, 95117
Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400019
Sarasota, Florida, 34239
Allergy, Asthma & Immunology Associates- Site Number : 8400009
Scottsdale, Arizona, 85251
Midwest Clinical Research Center - St. Louis- Site Number : 8400006
St Louis, Missouri, 63141
Clinical Trials Management Services - Thousand Oaks- Site Number : 8400053
Thousand Oaks, California, 91360
Asthma & Allergy Center - Toledo- Site Number : 8400017
Toledo, Ohio, 43617
Western States Clinical Research- Site Number : 8400014
Wheat Ridge, Colorado, 80033
Yuma Pulmonary & Sleep Research, LLC- Site Number : 8400072
Yuma, Arizona, 85364
China18 sites
Investigational Site Number : 1560011
Beijing, 100144
Investigational Site Number : 1560010
Changchun, 130021
Investigational Site Number : 1560017
Changsha, 410015
Investigational Site Number : 1560008
Chengdu, 610041
Investigational Site Number : 1560001
Guangzhou, 510120
Investigational Site Number : 1560009
Guangzhou, 510150
Investigational Site Number : 1560006
Hefei, 230032
Investigational Site Number : 1560014
Hohhot, 010050
Investigational Site Number : 1560018
Mianyang, 621000
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 : 1560005
Wenzhou, 325027
Investigational Site Number : 1560003
Wuhan, 430030
Investigational Site Number : 1560004
Xuzhou, 221006
Investigational Site Number : 1560016
Yangzhou, 225000
Investigational Site Number : 1560012
Zhanjiang, 524004
Argentina10 sites
Investigational Site Number : 0320007
Berazategui, Buenos Aires, 1886
Investigational Site Number : 0320005
Buenos Aires, 1121
Investigational Site Number : 0320004
Buenos Aires, 1414
Investigational Site Number : 0320001
Buenos Aires, 1425
Investigational Site Number : 0320003
La Plata, Buenos Aires, 1900
Investigational Site Number : 0320009
Mendoza, 5500
Investigational Site Number : 0320002
Rosario, Santa Fe Province, 2000
Investigational Site Number : 0320006
Rosario, Santa Fe Province, 2000
Investigational Site Number : 0320008
San Miguel de Tucumán, 4000
Investigational Site Number : 0320010
Santa Fe, 3000
Japan10 sites
Investigational Site Number : 3920011
Chūō, Tokyo, 104-0031
Investigational Site Number : 3920008
Fukushima, 960-1295
Investigational Site Number : 3920003
Higashiōmi, 527-8505
Investigational Site Number : 3920004
Kamogawa, Chiba, 296-0041
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
Investigational Site Number : 3920010
Yokohama, Kanagawa, 231-0801
Chile9 sites
Investigational Site Number : 1520008
Quillota, Valparaiso, 2260877
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 : 1520009
Santiago, Reg Metropolitana de Santiago, 7580206
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, 7750495
Investigational Site Number : 1520001
Talca, Maule Region, 3465584
Investigational Site Number : 1520010
Valdivia, Los Ríos Region, 5110683
Investigational Site Number : 1520011
Viña del Mar, Valparaiso, 2520598
Israel9 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 : 3760009
Ramat Gan, 5262100
Investigational Site Number : 3760004
Rehovot, 7610001
Investigational Site Number : 3760007
Tel Aviv, 6423906
Brazil8 sites
Hospital Dia do Pulmão- Site Number : 0760005
Blumenau, Santa Catarina, 89030-101
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
Inst 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, 05403-900
India8 sites
Investigational Site Number : 3560002
Coimbatore, 641028
Investigational Site Number : 3560006
Delhi, 110 029
Investigational Site Number : 3560009
Hyderabad, 500084
Investigational Site Number : 3560008
Kanpur, 208002
Investigational Site Number : 3560007
Kozhikode, 673008
Investigational Site Number : 3560003
Lucknow, 226006
Investigational Site Number : 3560001
Nagpur, 441203
Investigational Site Number : 3560004
Pune, 411057
Mexico7 sites
Investigational Site Number : 4840002
Chihuahua City, 31000
Investigational Site Number : 4840003
Durango, 34000
Investigational Site Number : 4840001
Guadalajara, Jalisco, 44100
Investigational Site Number : 4840007
Mérida, 97070
Investigational Site Number : 4840004
Monterrey, Nuevo León, 66465
Investigational Site Number : 4840005
San Juan del Río, Querétaro, 76800
Investigational Site Number : 4840008
Veracruz, 91910
Turkey (Türkiye)7 sites
Investigational Site Number : 7920001
Akdeniz, 33070
Investigational Site Number : 7920006
Bursa, 16059
Investigational Site Number : 7920002
Istanbul, 34098
Investigational Site Number : 7920003
Istanbul, 34854
Investigational Site Number : 7920004
Izmir, 35110
Investigational Site Number : 7920005
İzmit, 41001
Investigational Site Number : 7920007
Kayseri, 38039
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
Lochner ROAD, PRETORIA
South Korea6 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 : 4100003
Seoul, Seoul-teukbyeolsi, 08308
Investigational Site Number : 4100005
Seoul, 06351
United Kingdom6 sites
Investigational Site Number : 8260003
Birmingham, B15 2TH
Investigational Site Number : 8260008
Bradford, BD9 6RJ
Investigational Site Number : 8260009
Bristol, BS8 2RA
Investigational Site Number : 8260001
Cambridge, Cambridgeshire, CB2 2QQ
Investigational Site Number : 8260005
Chertsey, Surrey, KT16 0PZ
Investigational Site Number : 8260004
Glasgow, Edinburgh, City of, G12 0YN
Canada4 sites
Investigational Site Number : 1240003
Hamilton, Ontario, L8N 4A6
Investigational Site Number : 1240004
Sherbrooke, Quebec, J1H 5N4
Investigational Site Number : 1240005
Stoney Creek, Ontario, L8G 2V6
Investigational Site Number : 1240001
Trois-Rivières, Quebec, G8T 7A1
About this study
Official title: 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.
- Conditions
- Asthma
- Being tested
- Lunsekimig, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LunsekimigDrug
Pharmaceutical form: solution for injection Route of administration: subcutaneous
PlaceboDrug
Pharmaceutical form: solution for injection Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Lunsekimig Dose1 interval 1 | Experimental | Participants will receive Dose 1 of lunsekimig (subcutaneous injection) according to established dosing interval 1 Receives: Drug: Lunsekimig |
| Lunsekimig Dose 1 interval 2 | Experimental | Participants will receive Dose 1 of lunsekimig (subcutaneous injection) according to established dosing interval 2 Receives: Drug: Lunsekimig |
| Lunsekimig Dose 2 interval 1 | Experimental | Participants will receive Dose 2 of lunsekimig (subcutaneous injection) according to established dosing interval 1 Receives: Drug: Lunsekimig |
| Lunsekimig Dose 2 interval 2 | Experimental | Participants will receive Dose 2 of lunsekimig (subcutaneous injection) according to established dosing interval 2 Receives: Drug: Lunsekimig |
| Placebo | Placebo comparator | Participants will receive placebo (subcutaneous injection) according to established dosing intervals corresponding to Dose 1 and Dose 2 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized rate of asthma exacerbation events
Measured: From baseline to week 48
Secondary outcomes (18)
Change from baseline in pre-bronchodilator (BD) FEV1
Measured: From baseline to week 48
Change from baseline in post-BD FEV1
Measured: From baseline to week 48
The absolute change in the percent predicted FEV1 from baseline (pre-BD and post-BD)
Measured: From baseline to week 48
Proportion of participants with ≥ 0.5-point reduction in ACQ-5 score
ACQ-5 is Asthma control questionnaire assessing symptoms. Lower score shows better asthma control
Measured: From baseline to week 48
Change from baseline in ACQ-5 score
Measured: From baseline to week 48
Change from baseline in FeNO
Measured: From baseline to week 48
Time to first asthma exacerbation
Measured: From baseline to week 48
Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit
Measured: 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
Measured: From baseline to week 48
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) scores
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.
Measured: From baseline to week 48
Proportion of participants with ≥4-point improvement in SGRQ score
Measured: From baseline to week 48
Change from baseline in Asthma Quality of Life Questionnaire Standardized for 12 years and older (AQLQ{S} +12) scores
Measured: From baseline to week 48
Proportion of participants with ≥0.5-point improvement in AQLQ(S)+12 domain and total scores
Measured: From baseline to week 48
Change from baseline in ACQ scores
Measured: From baseline to week 48
Proportion of participants with ≥0.5-point reduction in ACQ-6 and ACQ-7 score
Measured: From baseline to week 48
Serum lunsekimig concentrations
Measured: From baseline to week 52
Anti-drug antibodies (ADA) against lunsekimig
Measured: 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)
Measured: From baseline to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start16 Oct 2023
- Primary completion23 Feb 2026
- Study completion11 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 685 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinial Science & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102005
- Sponsor's protocol ID
- DRI16762
- Other IDs
- U1111-1280-5514
- Acronym
- AIRCULES
- Status last verified
- Mar 2026
- First submitted
- 20 Oct 2023
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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
Publications
Seluk L, Davis AE, Rhoads S, Wechsler ME. Novel asthma treatments: Advancing beyond approved novel step-up therapies for asthma. Ann Allergy Asthma Immunol. 2025 Jan;134(1):9-18. doi: 10.1016/j.anai.2024.09.016. Epub 2024 Oct 10.
PubMed 39393433
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06102005
- Acronym / sponsor ID
- AIRCULES / DRI16762
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 685 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 23 Feb 2026 (actual)
- Study completion
- 11 Mar 2026 (actual)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Lunsekimig Dose1 interval 1 | Experimental | Drug: LunsekimigParticipants will receive Dose 1 of lunsekimig (subcutaneous injection) according to established dosing interval 1 |
| Lunsekimig Dose 1 interval 2 | Experimental | Drug: LunsekimigParticipants will receive Dose 1 of lunsekimig (subcutaneous injection) according to established dosing interval 2 |
| Lunsekimig Dose 2 interval 1 | Experimental | Drug: LunsekimigParticipants will receive Dose 2 of lunsekimig (subcutaneous injection) according to established dosing interval 1 |
| Lunsekimig Dose 2 interval 2 | Experimental | Drug: LunsekimigParticipants will receive Dose 2 of lunsekimig (subcutaneous injection) according to established dosing interval 2 |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo (subcutaneous injection) according to established dosing intervals corresponding to Dose 1 and Dose 2 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LunsekimigPharmaceutical form: solution for injection Route of administration: subcutaneous | Drug | Lunsekimig Dose 1 interval 2, Lunsekimig Dose 2 interval 1, Lunsekimig Dose 2 interval 2, Lunsekimig Dose1 interval 1 |
| PlaceboPharmaceutical form: solution for injection Route of administration: subcutaneous | Drug | Placebo |
Primary outcome
Annualized rate of asthma exacerbation events
Time frame: From baseline to week 48
18 secondary outcomes
Change from baseline in pre-bronchodilator (BD) FEV1
Time frame: From baseline to week 48
Change from baseline in post-BD FEV1
Time frame: 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
Proportion of participants with ≥ 0.5-point reduction in ACQ-5 score
Time frame: From baseline to week 48
Change from baseline in ACQ-5 score
Time frame: From baseline to week 48
Change from baseline in FeNO
Time frame: From baseline to week 48
Time to first asthma exacerbation
Time frame: 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
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
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) scores
Time frame: From baseline to week 48
Proportion of participants with ≥4-point improvement in SGRQ score
Time frame: 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
Proportion of participants with ≥0.5-point improvement in AQLQ(S)+12 domain and total scores
Time frame: From baseline to week 48
Change from baseline in ACQ scores
Time frame: 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
Serum lunsekimig concentrations
Time frame: From baseline to week 52
Anti-drug antibodies (ADA) against lunsekimig
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Derived from this study: PubMed 39393433Seluk L, Davis AE, Rhoads S, Wechsler ME. Novel asthma treatments: Advancing beyond approved novel step-up therapies for asthma. Ann Allergy Asthma Immunol. 2025 Jan;134(1):9-18. doi: 10.1016/j.anai.2024.09.016. Epub 2024 Oct 10.
- DRI16762 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinial Science & Operations study director
Sanofi
156 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lunsekimig in people with Asthma, run by Sanofi at 156 sites in 14 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 156 sites in United States, China, Argentina, Japan, Chile and 9 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Annualized rate of asthma exacerbation events (time frame: From baseline to week 48). 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 NCT06102005, which also lists 1 linked publication.
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 17 Mar 2026.