NCT06102005CompletedPhase 2
Dose Ranging Study of Lunsekimig Compared With Placebo-control in Adult Participants With Moderate-to-severe Asthma
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
Source: ClinicalTrials.gov · Last updated 17 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 685 (actual)
- First submitted
- 20 Oct 2023
- Start date
- 16 Oct 2023
- Primary completion date
- 23 Feb 2026
- Lead sponsor
- Sanofi
- Diseases
- Asthma
- NCT number
- NCT06102005
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 685
- From 16 Oct 2023 to the primary completion date, 23 Feb 2026
- 156 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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.
Other
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Who the study is looking for
- 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)
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (156)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Investigational Site Number : 0320007 Coordinator of this site? Confirm its status | Berazategui | Argentina | Unknown status |
| Investigational Site Number : 0320004 Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Investigational Site Number : 0320001 Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Investigational Site Number : 0320005 Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Investigational Site Number : 0320003 Coordinator of this site? Confirm its status | La Plata | Argentina | Unknown status |
| Investigational Site Number : 0320009 Coordinator of this site? Confirm its status | Mendoza | Argentina | Unknown status |
| Investigational Site Number : 0320002 Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Investigational Site Number : 0320006 Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Investigational Site Number : 0320008 Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Unknown status |
| Investigational Site Number : 0320010 Coordinator of this site? Confirm its status | Santa Fe | Argentina | Unknown status |
| Hospital Dia do Pulmão- Site Number : 0760005 Coordinator of this site? Confirm its status | Blumenau | Brazil | Unknown status |
| Centro de Estudos em Terapias Inovadoras- Site Number : 0760002 Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Universidade Federal de Goias- Site Number : 0760007 Coordinator of this site? Confirm its status | Goiânia | Brazil | Unknown status |
| Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001 Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Inst de Medicina Integral Professor Fernando Figueira- Site Number : 0760009 Coordinator of this site? Confirm its status | Recife | Brazil | Unknown status |
| CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760006 Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Associacao Proar- Site Number : 0760003 Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| Incor - Instituto do Coracao- Site Number : 0760011 Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Investigational Site Number : 1240003 Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Investigational Site Number : 1240004 Coordinator of this site? Confirm its status | Sherbrooke | Canada | Unknown status |
| Investigational Site Number : 1240005 Coordinator of this site? Confirm its status | Stoney Creek | Canada | Unknown status |
| Investigational Site Number : 1240001 Coordinator of this site? Confirm its status | Trois-Rivières | Canada | Unknown status |
| Investigational Site Number : 1520008 Coordinator of this site? Confirm its status | Quillota | Chile | Unknown status |
| Investigational Site Number : 1520002 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Investigational Site Number : 1520006 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Investigational Site Number : 1520005 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Investigational Site Number : 1520004 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Investigational Site Number : 1520009 Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Investigational Site Number : 1520001 Coordinator of this site? Confirm its status | Talca | Chile | Unknown status |
| Investigational Site Number : 1520010 Coordinator of this site? Confirm its status | Valdivia | Chile | Unknown status |
| Investigational Site Number : 1520011 Coordinator of this site? Confirm its status | Viña del Mar | Chile | Unknown status |
| Investigational Site Number : 1560011 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Investigational Site Number : 1560010 Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Investigational Site Number : 1560017 Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Investigational Site Number : 1560008 Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Investigational Site Number : 1560009 Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Investigational Site Number :1560001 Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Investigational Site Number : 1560006 Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Investigational Site Number : 1560014 Coordinator of this site? Confirm its status | Hohhot | China | Unknown status |
| Investigational Site Number : 1560018 Coordinator of this site? Confirm its status | Mianyang | China | Unknown status |
| Investigational Site Number : 1560007 Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Investigational Site Number : 1560002 Coordinator of this site? Confirm its status | Pingxiang | China | Unknown status |
| Investigational Site Number : 1560013 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Investigational Site Number : 1560015 Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Investigational Site Number : 1560005 Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| Investigational Site Number : 1560003 Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Investigational Site Number : 1560004 Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
| Investigational Site Number : 1560016 Coordinator of this site? Confirm its status | Yangzhou | China | Unknown status |
| Investigational Site Number : 1560012 Coordinator of this site? Confirm its status | Zhanjiang | China | Unknown status |
| Investigational Site Number : 8260003 Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Investigational Site Number : 8260008 Coordinator of this site? Confirm its status | Bradford | United Kingdom | Unknown status |
| Investigational Site Number : 8260009 Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Investigational Site Number : 8260001 Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| Investigational Site Number : 8260005 Coordinator of this site? Confirm its status | Chertsey | United Kingdom | Unknown status |
| Investigational Site Number : 8260004 Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Investigational Site Number : 3760006 Coordinator of this site? Confirm its status | Ashkelon | Israel | Unknown status |
| Investigational Site Number : 3760008 Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Investigational Site Number : 3760001 Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Investigational Site Number : 3760002 Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Investigational Site Number : 3760003 Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Investigational Site Number : 3760010 Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Investigational Site Number : 3760009 Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Investigational Site Number : 3760004 Coordinator of this site? Confirm its status | Rehovot | Israel | Unknown status |
| Investigational Site Number : 3760007 Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Investigational Site Number : 3560002 Coordinator of this site? Confirm its status | Coimbatore | India | Unknown status |
| Investigational Site Number : 3560006 Coordinator of this site? Confirm its status | Delhi | India | Unknown status |
| Investigational Site Number : 3560009 Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| Investigational Site Number : 3560008 Coordinator of this site? Confirm its status | Kanpur | India | Unknown status |
| Investigational Site Number : 3560007 Coordinator of this site? Confirm its status | Kozhikode | India | Unknown status |
| Investigational Site Number : 3560003 Coordinator of this site? Confirm its status | Lucknow | India | Unknown status |
| Investigational Site Number : 3560001 Coordinator of this site? Confirm its status | Nagpur | India | Unknown status |
| Investigational Site Number : 3560004 Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Investigational Site Number : 3920011 Coordinator of this site? Confirm its status | Chūō | Japan | Unknown status |
| Investigational Site Number : 3920008 Coordinator of this site? Confirm its status | Fukushima | Japan | Unknown status |
| Investigational Site Number : 3920003 Coordinator of this site? Confirm its status | Higashiōmi | Japan | Unknown status |
| Investigational Site Number : 3920004 Coordinator of this site? Confirm its status | Kamogawa | Japan | Unknown status |
| Investigational Site Number : 3920006 Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| Investigational Site Number : 3920009 Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| Investigational Site Number : 3920012 Coordinator of this site? Confirm its status | Miyazaki | Japan | Unknown status |
| Investigational Site Number : 3920002 Coordinator of this site? Confirm its status | Sakaidechō | Japan | Unknown status |
| Investigational Site Number : 3920005 Coordinator of this site? Confirm its status | Ube | Japan | Unknown status |
| Investigational Site Number : 3920010 Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Investigational Site Number : 4100002 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Investigational Site Number : 4100005 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Investigational Site Number : 4100001 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Investigational Site Number : 4100004 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Investigational Site Number : 4100006 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Investigational Site Number : 4100003 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Investigational Site Number : 4840002 Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Unknown status |
| Investigational Site Number : 4840003 Coordinator of this site? Confirm its status | Durango | Mexico | Unknown status |
| Investigational Site Number : 4840001 Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Investigational Site Number : 4840007 Coordinator of this site? Confirm its status | Mérida | Mexico | Unknown status |
| Investigational Site Number : 4840004 Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Investigational Site Number : 4840005 Coordinator of this site? Confirm its status | San Juan del Río | Mexico | Unknown status |
| Investigational Site Number : 4840008 Coordinator of this site? Confirm its status | Veracruz | Mexico | Unknown status |
| VitaLink Research - Anderson - East Greenville- Site Number : 8400063 Coordinator of this site? Confirm its status | Anderson | United States | Unknown status |
| Javara - Privia Medical Group - Annapolis- Site Number : 8400033 Coordinator of this site? Confirm its status | Annapolis | United States | Unknown status |
| University of Michigan Health System - Ann Arbor- Site Number : 8400004 Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Allianz Research Institute CO- Site Number : 8400026 Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Orion Clinical Research- Site Number : 8400001 Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| South Texas Medical Research Institute - TTS Research- Site Number : 8400010 Coordinator of this site? Confirm its status | Boerne | United States | Unknown status |
| Brigham & Women's Hospital- Site Number : 8400034 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Appalachian Clinical Research- Site Number : 8400050 Coordinator of this site? Confirm its status | Calhoun | United States | Unknown status |
| PMG Research of Christie Clinic- Site Number : 8400066 Coordinator of this site? Confirm its status | Champaign | United States | Unknown status |
| Velocity Clinical Research - Charleston- Site Number : 8400061 Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400029 Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Carolina Clinical Research - Charlotte- Site Number : 8400071 Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Bernstein Clinical Research Center- Site Number : 8400016 Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Beautiful Minds Clinical Research Center- Site Number : 8400049 Coordinator of this site? Confirm its status | Cutler Bay | United States | Unknown status |
| Baylor University Medical Center- Site Number : 8400002 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Clinical Research Associates of Central PA - Dubois- Site Number : 8400069 Coordinator of this site? Confirm its status | DuBois | United States | Unknown status |
| OK Clinical Research- Site Number : 8400021 Coordinator of this site? Confirm its status | Edmond | United States | Unknown status |
| Western Sky Medical Research- Site Number : 8400023 Coordinator of this site? Confirm its status | El Paso | United States | Unknown status |
| Velocity Clinical Research - Denver- Site Number : 8400027 Coordinator of this site? Confirm its status | Englewood | United States | Unknown status |
| Clinical Research Of Gastonia- Site Number : 8400013 Coordinator of this site? Confirm its status | Gastonia | United States | Unknown status |
| Qway Research - Hialeah- Site Number : 8400015 Coordinator of this site? Confirm its status | Hialeah | United States | Unknown status |
| Velocity Clinical Research Lafayette Site Number : 8400060 Coordinator of this site? Confirm its status | Lafayette | United States | Unknown status |
| Antelope Valley Clinical Trials- Site Number : 8400020 Coordinator of this site? Confirm its status | Lancaster | United States | Unknown status |
| Javara - Mankato Clinic- Site Number : 8400051 Coordinator of this site? Confirm its status | Mankato | United States | Unknown status |
| Metroplex Pulmonary and Sleep Center- Site Number : 8400022 Coordinator of this site? Confirm its status | McKinney | United States | Unknown status |
| Velocity Clinical Research - Medford- Site Number : 8400059 Coordinator of this site? Confirm its status | Medford | United States | Unknown status |
| New Access Medical Center- Site Number : 8400043 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Innovations Biotech- Site Number : 8400040 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Clintex Research Group - Miami - Coral Way- Site Number : 8400048 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| High Quality Research- Site Number : 8400039 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Deluxe Health Center- Site Number : 8400045 Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| Circuit Clinical - Middletown Medical - 111 Maltese Drive- Site Number : 8400065 Coordinator of this site? Confirm its status | Middletown | United States | Unknown status |
| Advanced Research Institute - New Port Richey- Site Number : 8400044 Coordinator of this site? Confirm its status | New Port Richey | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai- Site Number : 8400058 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Amicis Research Center - Northridge - Nordhoff Street- Site Number : 8400032 Coordinator of this site? Confirm its status | Northridge | United States | Unknown status |
| Pines Care Research Center- Site Number : 8400057 Coordinator of this site? Confirm its status | Pembroke Pines | United States | Unknown status |
| Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400007 Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| VAST Clinical Research- Site Number : 8400062 Coordinator of this site? Confirm its status | Plano | United States | Unknown status |
| Circuit Clinical - PMSI Comprehensive Healthcare for Life - Pottstown - Medical Drive- Site Number : 8400064 Coordinator of this site? Confirm its status | Pottstown | United States | Unknown status |
| Optimus Medical- Site Number : 8400046 Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Allergy and Asthma Associates of Santa Clara Valley Research Center- Site Number : 8400038 Coordinator of this site? Confirm its status | San Jose | United States | Unknown status |
| Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400019 Coordinator of this site? Confirm its status | Sarasota | United States | Unknown status |
| Allergy, Asthma & Immunology Associates- Site Number : 8400009 Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| Midwest Clinical Research Center - St. Louis- Site Number : 8400006 Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Clinical Trials Management Services - Thousand Oaks- Site Number : 8400053 Coordinator of this site? Confirm its status | Thousand Oaks | United States | Unknown status |
| Asthma & Allergy Center - Toledo- Site Number : 8400017 Coordinator of this site? Confirm its status | Toledo | United States | Unknown status |
| Western States Clinical Research- Site Number : 8400014 Coordinator of this site? Confirm its status | Wheat Ridge | United States | Unknown status |
| Yuma Pulmonary & Sleep Research, LLC- Site Number : 8400072 Coordinator of this site? Confirm its status | Yuma | United States | Unknown status |
| Investigational Site Number : 7100004 Coordinator of this site? Confirm its status | Benoni | South Africa | Unknown status |
| Investigational Site Number : 7100005 Coordinator of this site? Confirm its status | Benoni | South Africa | Unknown status |
| Investigational Site Number : 7100002 Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Investigational Site Number : 7100003 Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Investigational Site Number : 7100001 Coordinator of this site? Confirm its status | Durban | South Africa | Unknown status |
| Investigational Site Number : 7100006 Coordinator of this site? Confirm its status | Lochner ROAD | South Africa | Unknown status |
| Investigational Site Number : 7920001 Coordinator of this site? Confirm its status | Akdeniz | Turkey (Türkiye) | Unknown status |
| Investigational Site Number : 7920006 Coordinator of this site? Confirm its status | Bursa | Turkey (Türkiye) | Unknown status |
| Investigational Site Number : 7920002 Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Investigational Site Number : 7920003 Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Investigational Site Number : 7920004 Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
| Investigational Site Number : 7920005 Coordinator of this site? Confirm its status | İzmit | Turkey (Türkiye) | Unknown status |
| Investigational Site Number : 7920007 Coordinator of this site? Confirm its status | Kayseri | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.