Clinical trial NCT06676319: Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma
Official title: A Randomized, Phase 2, Double-blind, Placebo-controlled, Parallel-group, 2-arm Study to Investigate the Efficacy, Safety, and Tolerability of Subcutaneous Lunsekimig (SAR443765) in Adult Participants With High-risk Asthma Who Are Not Currently Eligible for Biologic Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-11-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a parallel-group, Phase 2, randomized, double-blind, placebo-controlled, 2-arm study for the treatment of asthma.

The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with SC lunsekimig compared with placebo in male and female participants (aged 18 to 80 years, inclusive) with asthma, who are not currently eligible for biologic treatments.

Study details include:

* The study duration will be approximately 64 weeks for participants not transitioning into the LTS study and approximately 60 weeks for participants transitioning into the LTS study.
* The investigational treatment duration will be up to approximately 52 weeks.
* The number of visits will be 18.


Eligibility criteria: Inclusion Criteria:

* Physician-diagnosed mild-to-moderate asthma for more than 12 months based on GINA guidelines.
* At least 1 asthma exacerbation in the year prior to Screening (Visit 1).
* Pre-BD FEV1 of equal or more than 40% of predicted normal (by Global Lung Function Initiative \[GLI\] standards) at Screening (Visit 1).

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

* Other severe lung diseases (eg, chronic obstructive pulmonary disease \[COPD\]. bronchiectasis, idiopathic pulmonary fibrosis, etc) which may impair lung function.
* 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 (Visit 1) (counting from the date of completion of treatment for asthma exacerbation).
* Participants who have experienced an upper or lower respiratory tract infection within the 4 weeks prior to Screening (Visit 1).
* Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
* Evidence of any infection requiring systemic anti-infective treatment within 2 weeks before Screening (Visit 1) or during the screening period. Significant viral infections within 2 weeks before Screening (Visit 1) or during the screening period even if the participant has not received systemic antiviral treatment (eg, influenza receiving only symptomatic treatment).
* 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 TB), or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening (Visit 1).
* 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.

NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical study.

Primary outcomes:
measure: Annualized rate of asthma exacerbation events
timeFrame: From baseline up to 52 weeks
Secondary outcomes:
measure: Change from baseline in prebronchodilator (BD) forced expiratory volume in 1 second (FEV1)
timeFrame: From baseline to week 52
measure: Change from baseline in Asthma Control Questionnaire5 (ACQ-5) score
timeFrame: From baseline to week 52
measure: Change from baseline in FeNO level
timeFrame: From baseline to week 52
measure: Annualized rate of loss of asthma control events (LOAC) events
timeFrame: From baseline to week 52
measure: Annualized rate of asthma exacerbations requiring hospitalization or emergency room or urgent care visit
timeFrame: From baseline to week 52
measure: Total systemic corticosteroid dose exposure
timeFrame: From baseline to week 52
measure: Change from baseline in Asthma Quality of Life Questionnaire Standardized (AQLQ{S}) scores
timeFrame: From baseline to week 52
measure: Change from baseline in the Asthma Daytime Symptom Diary (ADSD) daily morning and evening score
timeFrame: From baseline to week 52
measure: Serum lunsekimig concentrations
timeFrame: From baseline to week 56
measure: Incidence and titer of anti-drug antibodies (ADA) against lunsekimig
timeFrame: From baseline to week 56
measure: Incidence of participants with treatment-emergent adverse events (TEAEs), including local reactions, adverse events of special interests (AESIs), serious adverse events (SAEs)
timeFrame: From baseline to week 56
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Chandler Clinical Research Trials- Site Number : 8400075
state: Arizona
city: Surprise
country: United States
facility: Epic Medical Research - Surprise- Site Number : 8400052
state: Arizona
city: Tucson
country: United States
facility: Tucson Clinical Research Institute - Site number: 8400085
state: Arizona
city: La Jolla
country: United States
facility: Modena Allergy + Asthma- Site Number : 8400021
state: California
city: La Mesa
country: United States
facility: Velocity Clinical Research - San Diego- Site Number : 8400024
state: California
city: Los Angeles
country: United States
facility: Downtown L.A. Research Center- Site Number : 8400080
state: California
city: North Hollywood
country: United States
facility: Carbon Health - North Hollywood - NoHo West- Site Number : 8400061
state: California
city: San Mateo
country: United States
facility: Carbon Health - San Mateo CA Urgent Care & Primary Care- Site Number : 8400062
state: California
city: Boynton Beach
country: United States
facility: Helix Biomedics- Site Number : 8400005
state: Florida
city: Cutler Bay
country: United States
facility: Beautiful Minds Clinical Research Center- Site Number : 8400019
state: Florida
city: Davie
country: United States
facility: Alfa Medical Research- Site Number : 8400071
state: Florida
city: Inverness
country: United States
facility: Royal Clinical Trials- Site Number : 8400067
state: Florida
city: Lady Lake
country: United States
facility: Premier Medical Associates- Site Number : 8400077
state: Florida
city: Margate
country: United States
facility: D&H Pompano Research Center- Site Number : 8400072
state: Florida
city: Miami
country: United States
facility: Research Institute of South Florida- Site Number : 8400023
state: Florida
city: Miami
country: United States
facility: Innovations Biotech- Site Number : 8400044
state: Florida
city: Oviedo
country: United States
facility: Oviedo Medical Research - Site number: 8400091
state: Florida
city: Pembroke Pines
country: United States
facility: Tellabio International Research Services- Site Number : 8400083
state: Florida
city: Pensacola
country: United States
facility: Avanza Medical Research Center- Site Number : 8400056
state: Florida
city: Plantation
country: United States
facility: Private Practice - Dr. Frank Hull - Plantation- Site Number : 8400079
state: Florida
city: Cordele
country: United States
facility: Private Practice - Dr. David Kavtaradze- Site Number : 8400081
state: Georgia
city: Boise
country: United States
facility: Treasure Valley Medical Research- Site Number : 8400004
state: Idaho
city: Champaign
country: United States
facility: Christie Clinic on University- Site Number : 8400003
state: Illinois
city: Rockville
country: United States
facility: Velocity Clinical Research - Rockville- Site Number : 8400036
state: Maryland
city: Silver Spring
country: United States
facility: Javara - Privia Medical Group - Silver Spring Lockwood- Site Number : 8400042
state: Maryland
city: Mankato
country: United States
facility: Javara - Mankato Clinic- Site Number : 8400001
state: Minnesota
city: Hannibal
country: United States
facility: Hannibal Regional Healthcare System-HRMG-Hannibal- Site Number : 8400078
state: Missouri
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai - Mount Sinai Health System- Site Number : 8400069
state: New York
city: Statesville
country: United States
facility: Piedmont Healthcare- Site Number : 8400064
state: North Carolina
city: Toledo
country: United States
facility: Asthma & Allergy Center - Toledo- Site Number : 8400020
state: Ohio
city: Edmond
country: United States
facility: OK Clinical Research- Site Number : 8400060
state: Oklahoma
city: DuBois
country: United States
facility: Clinical Research Associates of Central PA - Dubois- Site Number : 8400013
state: Pennsylvania
city: Greenville
country: United States
facility: ADAC Research, PA- Site Number : 8400070
state: South Carolina
city: Austin
country: United States
facility: Orion Clinical Research
state: Texas
city: Boerne
country: United States
facility: South Texas Medical Research Institute - TTS Research- Site Number : 8400015
state: Texas
city: DeSoto
country: United States
facility: Epic Medical Research- Site Number : 8400051
state: Texas
city: Houston
country: United States
facility: Axsendo Clinical Research of Houston- Site Number : 8400065
state: Texas
city: Lampasas
country: United States
facility: Radiance Clinical Research
state: Texas
city: McKinney
country: United States
facility: Metroplex Pulmonary and Sleep Center- Site Number : 8400012
state: Texas
city: San Antonio
country: United States
facility: STAAMP Research LLC- Site Number : 8400059
state: Texas
city: San Antonio
country: United States
facility: Bandera Family Health Care - San Antonio- Site Number : 8400049
state: Texas
city: San Marcos
country: United States
facility: Javara Inc/Privia Medical Group Gulf Coast, PLLC- Site Number : 8400040
state: Texas
city: Stephenville
country: United States
facility: Javara Inc/Privia Medical Group North Texas, PLLC- Site Number : 8400038
state: Texas
city: Sugar Land
country: United States
facility: Simcare Medical Research- Site Number : 8400102
state: Texas
city: Berazategui
country: Argentina
facility: Investigational Site Number : 0320007
state: Buenos Aires
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320006
state: Santa Fe
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320010
state: Santa Fe
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320016
state: Santa Fe
city: San Miguel de Tucumán
country: Argentina
facility: Investigational Site Number : 0320003
state: Tucumán
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320012
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320005
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320002
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320001
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320004
city: Corrientes
country: Argentina
facility: Investigational Site Number : 0320008
city: Mendoza
country: Argentina
facility: Investigational Site Number : 0320014
city: Mendoza
country: Argentina
facility: Investigational Site Number : 0320015
city: Santa Fe
country: Argentina
facility: Investigational Site Number : 0320009
city: Gent
country: Belgium
facility: Investigational Site Number : 0560001
city: Liège
country: Belgium
facility: Investigational Site Number : 0560003
city: Mechelen
country: Belgium
facility: Investigational Site Number : 0560002
city: Kelowna
country: Canada
facility: Investigational Site Number : 1240011
state: British Columbia
city: North Vancouver
country: Canada
facility: Investigational Site Number : 1240012
state: British Columbia
city: Guelph
country: Canada
facility: Investigational Site Number : 1240003
state: Ontario
city: Stoney Creek
country: Canada
facility: Investigational Site Number : 1240006
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site Number : 1240008
state: Ontario
city: Montreal
country: Canada
facility: Investigational Site Number : 1240014
state: Quebec
city: Sherbrooke
country: Canada
facility: Investigational Site Number : 1240002
state: Quebec
city: Concepción
country: Chile
facility: Investigational Site Number : 1520008
state: Biobío
city: Talcahuano
country: Chile
facility: Investigational Site Number : 1520011
state: Biobío
city: Talca
country: Chile
facility: Investigational Site Number : 1520002
state: Maule
city: Santiago
country: Chile
facility: Investigational Site Number : 1520006
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520001
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520003
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520009
state: Reg Metropolitana De Santiago
city: Quillota
country: Chile
facility: Investigational Site Number : 1520005
state: Valparaíso
city: Viña del Mar
country: Chile
facility: Investigational Site Number : 1520004
state: Valparaíso
city: Viña Del Mar
country: Chile
facility: Investigational Site Number : 1520007
state: Valparaíso
city: Beijing
country: China
facility: Investigational Site Number : 1560027
city: Changchun
country: China
facility: Investigational Site Number : 1560005
city: Chengde
country: China
facility: Investigational Site Number : 1560021
city: Chengdu
country: China
facility: Investigational Site Number : 1560039
city: Foshan
country: China
facility: Investigational Site Number : 1560028
city: Guangzhou
country: China
facility: Investigational Site Number : 1560010
city: Guangzhou
country: China
facility: Investigational Site Number : 1560033
city: Guiyang
country: China
facility: Investigational Site Number : 1560037
city: Hangzhou
country: China
facility: Investigational Site Number : 1560042
city: Hebei
country: China
facility: Investigational Site Number : 1560009
city: Hefei
country: China
facility: Investigational Site Number : 1560040
city: Hohhot
country: China
facility: Investigational Site Number : 1560006
city: Hohhot
country: China
facility: Investigational Site Number : 1560007
city: Huizhou
country: China
facility: Investigational Site Number : 1560029
city: Huizhou
country: China
facility: Investigational Site Number : 1560011
city: Jiazhuang
country: China
facility: Investigational Site Number : 1560025
city: Jinan
country: China
facility: Investigational Site Number : 1560034
city: Jinan
country: China
facility: Investigational Site Number : 1560038
city: Lanzhou
country: China
facility: Investigational Site Number : 1560030
city: Luoyang
country: China
facility: Investigational Site Number : 1560018
city: Nanchang
country: China
facility: Investigational Site Number : 1560003
city: Ningbo
country: China
facility: Investigational Site Number : 1560014
city: Shanghai
country: China
facility: Investigational Site Number : 1560001
city: Shanghai
country: China
facility: Investigational Site Number : 1560043
city: Shenyang
country: China
facility: Investigational Site Number : 1560016
city: Suzhou
country: China
facility: Investigational Site Number : 1560019
city: Suzhou
country: China
facility: Investigational Site Number : 1560008
city: Taiyuan
country: China
facility: Investigational Site Number : 1560017
city: Tianjin
country: China
facility: Investigational Site Number : 1560002
city: Tianjin
country: China
facility: Investigational Site Number : 1560013
city: Wuhan
country: China
facility: Investigational Site Number : 1560022
city: Xi'an
country: China
facility: Investigational Site Number : 1560036
city: Xi'an
country: China
facility: Investigational Site Number : 1560032
city: Xianyang
country: China
facility: Investigational Site Number : 1560044
city: Xuzhou
country: China
facility: Investigational Site Number : 1560012
city: Yangzhou
country: China
facility: Investigational Site Number : 1560047
city: Zhengzhou
country: China
facility: Investigational Site Number : 1560026
city: Zigong
country: China
facility: Investigational Site Number : 1560045
city: Vejle
country: Denmark
facility: Investigational Site Number : 2080002
city: Lyon
country: France
facility: Investigational Site Number : 2500004
city: Montpellier
country: France
facility: Investigational Site Number : 2500003
city: Pessac
country: France
facility: Investigational Site Number : 2500005
city: Bendorf
country: Germany
facility: Investigational Site Number : 2760002
city: Düsseldorf
country: Germany
facility: Investigational Site Number : 6420001
city: Leipzig
country: Germany
facility: Investigational Site Number : 2760001
city: Gödöllő
country: Hungary
facility: Investigational Site Number : 3480002
city: Hajdunanas
country: Hungary
facility: Investigational Site Number : 3480003
city: Mosonmagyaróvár
country: Hungary
facility: Investigational Site Number : 3480004
city: Püspökladány
country: Hungary
facility: Investigational Site Number : 3480001
city: Haifa
country: Israel
facility: Investigational Site Number : 3760006
city: Jerusalem
country: Israel
facility: Investigational Site Number : 3760003
city: Jerusalem
country: Israel
facility: Investigational Site Number : 3760002
city: Petah Tikva
country: Israel
facility: Investigational Site Number : 3760005
city: Rehovot
country: Israel
facility: Investigational Site Number : 3760001
city: Tel Aviv
country: Israel
facility: Investigational Site Number : 3760004
city: Rozzano
country: Italy
facility: Investigational Site Number : 3800003
state: Milano
city: Ostrowiec Swietokrzyski
country: Poland
facility: Investigational Site Number : 6160003
state: Swietokrzyskie
city: Katowice
country: Poland
facility: Investigational Site Number : 6160009
city: Cluj-Napoca
country: Romania
facility: Investigational Site Number : 6420002
city: Santiago de Compostela
country: Spain
facility: Investigational Site Number : 7240005
state: A Coruña [La Coruña]
city: Badalona
country: Spain
facility: Investigational Site Number : 7240010
state: Barcelona [Barcelona]
city: Girona
country: Spain
facility: Investigational Site Number : 7240016
state: Girona [Gerona]
city: Barcelona
country: Spain
facility: Investigational Site Number : 7240009
city: Madrid
country: Spain
facility: Investigational Site Number : 7240013
city: Madrid
country: Spain
facility: Investigational Site Number : 7240008
city: Madrid
country: Spain
facility: Investigational Site Number : 7240011
city: Madrid
country: Spain
facility: Investigational Site Number : 7240002
city: Málaga
country: Spain
facility: Investigational Site Number : 7240006
city: Palma
country: Spain
facility: Investigational Site Number : 7240001
city: Gothenburg
country: Sweden
facility: Investigational Site Number : 7520003
city: Lund
country: Sweden
facility: Investigational Site Number : 7520002
city: Kaohsiung City
country: Taiwan
facility: Investigational Site Number : 1580005
city: Taichung
country: Taiwan
facility: Investigational Site Number : 1580007
city: Akdeniz
country: Turkey
facility: Investigational Site Number : 7920001
city: Kayseri
country: Turkey
facility: Investigational Site Number : 7920003
city: Kirikkale
country: Turkey
facility: Investigational Site Number : 7920002
city: Corby
country: United Kingdom
facility: Investigational Site Number : 8260007
state: Northamptonshire
city: Nottingham
country: United Kingdom
facility: Investigational Site Number : 8260006
state: Nottinghamshire
city: Oxford
country: United Kingdom
facility: Investigational Site Number : 8260008
state: Oxfordshire
city: Barnsley
country: United Kingdom
facility: Investigational Site Number : 8260005
city: Bradford
country: United Kingdom
facility: Investigational Site Number : 8260003
city: London
country: United Kingdom
facility: Investigational Site Number : 8260001
Study officials:
References: