Dose Ranging Study of Lunsekimig Compared With Placebo-control in Adult Participants With Moderate-to-severe Asthma
- Conditions
- Asthma
- Interventions
- Drug: LunsekimigDrug: Placebo
- Registration Number
- NCT06102005
- Lead Sponsor
- Sanofi
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 630
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lunsekimig Dose1 interval 1 Lunsekimig Participants will receive Dose 1 of lunsekimig (subcutaneous injection) according to established dosing interval 1 Lunsekimig Dose 2 interval 2 Lunsekimig Participants will receive Dose 2 of lunsekimig (subcutaneous injection) according to established dosing interval 2 Lunsekimig Dose 2 interval 1 Lunsekimig Participants will receive Dose 2 of lunsekimig (subcutaneous injection) according to established dosing interval 1 Lunsekimig Dose 1 interval 2 Lunsekimig Participants will receive Dose 1 of lunsekimig (subcutaneous injection) according to established dosing interval 2 Placebo Placebo Participants will receive placebo (subcutaneous injection) according to established dosing intervals corresponding to Dose 1 and Dose 2
- Primary Outcome Measures
Name Time Method Annualized rate of asthma exacerbation events From baseline to week 48
- Secondary Outcome Measures
Name Time Method Change from baseline in pre-bronchodilator (BD) FEV1 From baseline to week 48 The absolute change in the percent predicted FEV1 from baseline (pre-BD and post-BD) From baseline to week 48 Average number of inhalations per day of short-acting beta 2-agoinst (SABA) or Low dose ICS/formoterol for symptom relief From baseline to week 48 Change from baseline in FeNO From baseline to week 48 Time to first asthma exacerbation From baseline to week 48 Annualized rate of loss of asthma control events (LOAC) events From baseline to week 48 Time to first LOAC event From baseline to week 48 Change from baseline in post-BD FEV1 From baseline to week 48 Proportion of participants with ≥ 0.5-point reduction in ACQ-5 score From baseline to week 48 ACQ-5 is Asthma control questionnaire assessing symptoms. Lower score shows better asthma control
Change from baseline in ACQ-5 score From baseline to week 48 Change from baseline in St. George's Respiratory Questionnaire (SGRQ) scores 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.
Change from baseline in Asthma Quality of Life Questionnaire Standardized (AQLQ{S}) scores From baseline to week 48 Change from baseline in ACQ scores From baseline to week 48 Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit From baseline to week 48 Serum lunsekimig concentrations From baseline to week 48 Incidence of participants with treatment-emergent adverse events (TEAEs), including local reactions, adverse events of special interests (AESIs), serious adverse events (SAEs) From baseline to week 48 Anti-drug antibodies (ADA) against lunsekimig From baseline to week 48
Trial Locations
- Locations (149)
Icahn School of Medicine at Mount Si- Site Number : 8400058
🇺🇸New York, New York, United States
Clinical Research Of Gastonia- Site Number : 8400013
🇺🇸Gastonia, North Carolina, United States
Bernstein Clinical Research Center- Site Number : 8400016
🇺🇸Cincinnati, Ohio, United States
Asthma & Allergy Center - Toledo- Site Number : 8400017
🇺🇸Toledo, Ohio, United States
OK Clinical Research- Site Number : 8400021
🇺🇸Edmond, Oklahoma, United States
Velocity Clinical Research - Medford- Site Number : 8400059
🇺🇸Medford, Oregon, United States
Clinical Research Associates of Central PA - Dubois- Site Number : 8400069
🇺🇸DuBois, Pennsylvania, United States
Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400007
🇺🇸Pittsburgh, Pennsylvania, United States
VitaLink Research - Anderson - East Greenville- Site Number : 8400063
🇺🇸Anderson, South Carolina, United States
Velocity Clinical Research - Charleston- Site Number : 8400061
🇺🇸Charleston, South Carolina, United States
South Texas Medical Research Institute - TTS Research- Site Number : 8400010
🇺🇸Boerne, Texas, United States
Baylor University Medical Center- Site Number : 8400002
🇺🇸Dallas, Texas, United States
Universidade Federal de Goias- Site Number : 0760007
🇧🇷Goiânia, Goiás, Brazil
Centro de Estudos em Terapias Inovadoras- Site Number : 0760002
🇧🇷Curitiba, Paraná, Brazil
Inst de Medicina Integral Professor Fernando Figueira- Site Number : 0760009
🇧🇷Recife, Pernambuco, Brazil
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Dia do Pulmão- Site Number : 0760005
🇧🇷Blumenau, Santa Catarina, Brazil
CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760006
🇧🇷Rio de Janeiro, Brazil
Antelope Valley Clinical Trials- Site Number : 8400020
🇺🇸Lancaster, California, United States
Amicis Research Center- Site Number : 8400032
🇺🇸Northridge, California, United States
Clinical Trials Management Services, LLC- Site Number : 8400053
🇺🇸Thousand Oaks, California, United States
Allianz Research Institute CO- Site Number : 8400026
🇺🇸Aurora, Colorado, United States
Velocity Clinical Research - Denver- Site Number : 8400027
🇺🇸Denver, Colorado, United States
Beautiful Minds Clinical Research Center- Site Number : 8400049
🇺🇸Cutler Bay, Florida, United States
Deluxe Health Center- Site Number : 8400045
🇺🇸Miami Lakes, Florida, United States
Clintex Research Group Inc.- Site Number : 8400048
🇺🇸Miami, Florida, United States
High Quality Research- Site Number : 8400039
🇺🇸Miami, Florida, United States
Innovations Biotech- Site Number : 8400040
🇺🇸Miami, Florida, United States
New Access Research & Medical Center- Site Number : 8400043
🇺🇸Miami, Florida, United States
Appalachian Clinical Research- Site Number : 8400050
🇺🇸Calhoun, Georgia, United States
Velocity Clinical Research Lafayette Site Number : 8400060
🇺🇸Lafayette, Louisiana, United States
Javara Inc- Site Number : 8400033
🇺🇸Annapolis, Maryland, United States
Javara Inc/Mankato Clinic,- Site Number : 8400051
🇺🇸Mankato, Minnesota, United States
American Carolina Clinical Research- Site Number : 8400071
🇺🇸Charlotte, North Carolina, United States
Tryon Medical Research- Site Number : 8400029
🇺🇸Charlotte, North Carolina, United States
PMSI Comprehensive Healthcare for Life- Site Number : 8400064
🇺🇸Pottstown, Pennsylvania, United States
Orion Clinical Research- Site Number : 8400001
🇺🇸Austin, Texas, United States
Western Sky Medical Research- Site Number : 8400023
🇺🇸El Paso, Texas, United States
Metroplex Pulmonary and Sleep Center- Site Number : 8400022
🇺🇸McKinney, Texas, United States
VAST Clinical Research- Site Number : 8400062
🇺🇸Plano, Texas, United States
Investigational Site Number : 0320007
🇦🇷Berazategui, Buenos Aires, Argentina
Investigational Site Number : 0320003
🇦🇷La Plata, Buenos Aires, Argentina
Investigational Site Number : 0320006
🇦🇷Rosario, Santa Fe, Argentina
Investigational Site Number : 0320005
🇦🇷Buenos Aires, Argentina
Investigational Site Number : 0320004
🇦🇷Buenos Aires, Argentina
Investigational Site Number : 0320001
🇦🇷Buenos Aires, Argentina
Investigational Site Number : 0320009
🇦🇷Mendoza, Argentina
Investigational Site Number : 0320008
🇦🇷San Miguel de Tucumán, Argentina
Investigational Site Number : 0320010
🇦🇷Santa Fe, Argentina
Proar- Site Number : 0760003
🇧🇷Salvador, Bahia, Brazil
Investigational Site Number : 1240005
🇨🇦Stoney Creek, Ontario, Canada
Investigational Site Number : 1240004
🇨🇦Sherbrooke, Quebec, Canada
Investigational Site Number : 1240001
🇨🇦Trois-rivières, Quebec, Canada
Investigational Site Number : 1520010
🇨🇱Valdivia, Los Ríos, Chile
Investigational Site Number : 1520001
🇨🇱Talca, Maule, Chile
Investigational Site Number : 1520006
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520005
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520004
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520009
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520002
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520008
🇨🇱Quillota, Valparaíso, Chile
Investigational Site Number : 1520011
🇨🇱Viña Del Mar, Valparaíso, Chile
Investigational Site Number : 1560011
🇨🇳Beijing, China
Investigational Site Number : 1560010
🇨🇳Changchun, China
Investigational Site Number : 1560017
🇨🇳Changsha, China
Investigational Site Number : 1560008
🇨🇳Chengdu, China
Investigational Site Number : 1560001
🇨🇳Guangzhou, China
Investigational Site Number : 1560009
🇨🇳Guangzhou, China
Investigational Site Number : 1560006
🇨🇳Hefei, China
Investigational Site Number : 1560014
🇨🇳Hohhot, China
Investigational Site Number : 1560018
🇨🇳Mianyang, China
Investigational Site Number : 1560007
🇨🇳Nanchang, China
Investigational Site Number : 1560002
🇨🇳Pingxiang, China
Investigational Site Number : 1560015
🇨🇳Shenyang, China
Investigational Site Number : 1560005
🇨🇳Wenzhou, China
Investigational Site Number : 1560003
🇨🇳Wuhan, China
Investigational Site Number : 1560004
🇨🇳Xuzhou, China
Investigational Site Number : 1560016
🇨🇳Yangzhou, China
Investigational Site Number : 1560012
🇨🇳Zhanjiang, China
Investigational Site Number : 3560002
🇮🇳Coimbatore, India
Investigational Site Number : 3560009
🇮🇳Hyderabad, India
Investigational Site Number : 3560008
🇮🇳Kanpur, India
Investigational Site Number : 3560007
🇮🇳Kozhikode, India
Investigational Site Number : 3560003
🇮🇳Lucknow, India
Investigational Site Number : 3560001
🇮🇳Nagpur, India
Investigational Site Number : 3560004
🇮🇳Pune, India
Investigational Site Number : 3760006
🇮🇱Ashkelon, Israel
Investigational Site Number : 3760001
🇮🇱Haifa, Israel
Investigational Site Number : 3760008
🇮🇱Haifa, Israel
Investigational Site Number : 3760003
🇮🇱Jerusalem, Israel
Investigational Site Number : 3760002
🇮🇱Jerusalem, Israel
Investigational Site Number : 3760010
🇮🇱Petah Tikva, Israel
Investigational Site Number : 3760009
🇮🇱Ramat Gan, Israel
Investigational Site Number : 3760004
🇮🇱Rehovot, Israel
Investigational Site Number : 3760007
🇮🇱Tel Aviv, Israel
Investigational Site Number : 3920004
🇯🇵Kamogawa, Chiba, Japan
Investigational Site Number : 3920002
🇯🇵Sakaide, Kagawa, Japan
Investigational Site Number : 3920010
🇯🇵Yokohama, Kanagawa, Japan
Investigational Site Number : 3920011
🇯🇵Chuo, Tokyo, Japan
Investigational Site Number : 3920005
🇯🇵UBE, Yamaguchi, Japan
Investigational Site Number : 3920008
🇯🇵Fukushima, Japan
Investigational Site Number : 3920003
🇯🇵Higashiomi, Japan
Investigational Site Number : 3920006
🇯🇵Kyoto, Japan
Investigational Site Number : 3920009
🇯🇵Kyoto, Japan
Investigational Site Number : 3920012
🇯🇵Miyazaki, Japan
Investigational Site Number : 7920002
🇹🇷Istanbul, Turkey
Investigational Site Number : 4100002
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100001
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100004
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100006
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100003
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100005
🇰🇷Seoul, Korea, Republic of
Investigational Site Number : 4840004
🇲🇽Monterrey, Nuevo León, Mexico
Investigational Site Number : 4840005
🇲🇽San Juan Del Río, Querétaro, Mexico
Investigational Site Number : 4840002
🇲🇽Chihuahua, Mexico
Investigational Site Number : 4840003
🇲🇽Durango, Mexico
Investigational Site Number : 4840007
🇲🇽Mérida, Mexico
Investigational Site Number : 7100004
🇿🇦Benoni, South Africa
Investigational Site Number : 7100003
🇿🇦Cape Town, South Africa
Investigational Site Number : 7100002
🇿🇦Cape Town, South Africa
Investigational Site Number : 7100001
🇿🇦Durban, South Africa
Investigational Site Number : 7100005
🇿🇦Johannesburg, South Africa
Investigational Site Number : 7100006
🇿🇦Pretoria, South Africa
Investigational Site Number : 7920001
🇹🇷Akdeniz, Turkey
Investigational Site Number : 7920006
🇹🇷Bursa, Turkey
Investigational Site Number : 7920003
🇹🇷Istanbul, Turkey
Investigational Site Number : 7920004
🇹🇷Izmir, Turkey
Investigational Site Number : 7920005
🇹🇷Izmit, Turkey
Investigational Site Number : 7920007
🇹🇷Kayseri, Turkey
Investigational Site Number : 8260001
🇬🇧Cambridge, Cambridgeshire, United Kingdom
Investigational Site Number : 8260004
🇬🇧Glasgow, Edinburgh, City Of, United Kingdom
Investigational Site Number : 8260005
🇬🇧Chertsey, Surrey, United Kingdom
Investigational Site Number : 8260003
🇬🇧Birmingham, United Kingdom
Investigational Site Number : 8260008
🇬🇧Bradford, United Kingdom
Investigational Site Number : 8260009
🇬🇧Bristol, United Kingdom
Allergy, Asthma & Immunology Associates- Site Number : 8400009
🇺🇸Scottsdale, Arizona, United States
Yuma Pulmonary & Sleep Research, LLC- Site Number : 8400072
🇺🇸Yuma, Arizona, United States
Optimus Medical- Site Number : 8400046
🇺🇸San Francisco, California, United States
Allergy and Asthma Associates of Santa Clara Valley Research Center- Site Number : 8400038
🇺🇸San Jose, California, United States
Western States Clinical Research- Site Number : 8400014
🇺🇸Wheat Ridge, Colorado, United States
Qway Research - Hialeah- Site Number : 8400015
🇺🇸Hialeah, Florida, United States
Advanced Research Institute - New Port Richey- Site Number : 8400044
🇺🇸New Port Richey, Florida, United States
Pines Care Research Center- Site Number : 8400057
🇺🇸Pembroke Pines, Florida, United States
Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400019
🇺🇸Sarasota, Florida, United States
PMG Research of Christie Clinic- Site Number : 8400066
🇺🇸Champaign, Illinois, United States
Brigham & Women's Hospital- Site Number : 8400034
🇺🇸Boston, Massachusetts, United States
University of Michigan Health System - Ann Arbor- Site Number : 8400004
🇺🇸Ann Arbor, Michigan, United States
Midwest Clinical Research Center - St. Louis- Site Number : 8400006
🇺🇸Saint Louis, Missouri, United States
Circuit Clinical - Middletown Medical - 111 Maltese Drive- Site Number : 8400065
🇺🇸Middletown, New York, United States