Clinical trial NCT06102005: Dose Ranging Study of Lunsekimig Compared With Placebo-control in Adult Participants With Moderate-to-severe Asthma
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-10-26
Enrollment: 685
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 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Annualized rate of asthma exacerbation events
timeFrame: From baseline to week 48
Secondary outcomes:
measure: Change from baseline in pre-bronchodilator (BD) FEV1
timeFrame: From baseline to week 48
measure: Change from baseline in post-BD FEV1
timeFrame: From baseline to week 48
measure: The absolute change in the percent predicted FEV1 from baseline (pre-BD and post-BD)
timeFrame: From baseline to week 48
measure: Proportion of participants with ≥ 0.5-point reduction in ACQ-5 score
timeFrame: From baseline to week 48
measure: Change from baseline in ACQ-5 score
timeFrame: From baseline to week 48
measure: Change from baseline in FeNO
timeFrame: From baseline to week 48
measure: Time to first asthma exacerbation
timeFrame: From baseline to week 48
measure: Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit
timeFrame: From baseline to week 48
measure: Average number of inhalations per day of short-acting beta 2-agoinst (SABA), Low dose ICS/formoterol or ICS/SABA for symptom relief
timeFrame: From baseline to week 48
measure: Change from baseline in St. George's Respiratory Questionnaire (SGRQ) scores
timeFrame: From baseline to week 48
measure: Proportion of participants with ≥4-point improvement in SGRQ score
timeFrame: From baseline to week 48
measure: Change from baseline in Asthma Quality of Life Questionnaire Standardized for 12 years and older (AQLQ{S} +12) scores
timeFrame: From baseline to week 48
measure: Proportion of participants with ≥0.5-point improvement in AQLQ(S)+12 domain and total scores
timeFrame: From baseline to week 48
measure: Change from baseline in ACQ scores
timeFrame: From baseline to week 48
measure: Proportion of participants with ≥0.5-point reduction in ACQ-6 and ACQ-7 score
timeFrame: From baseline to week 48
measure: Serum lunsekimig concentrations
timeFrame: From baseline to week 52
measure: Anti-drug antibodies (ADA) against lunsekimig
timeFrame: From baseline to week 52
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 52
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Allergy, Asthma & Immunology Associates- Site Number : 8400009
state: Arizona
city: Yuma
country: United States
facility: Yuma Pulmonary & Sleep Research, LLC- Site Number : 8400072
state: Arizona
city: Lancaster
country: United States
facility: Antelope Valley Clinical Trials- Site Number : 8400020
state: California
city: Northridge
country: United States
facility: Amicis Research Center - Northridge - Nordhoff Street- Site Number : 8400032
state: California
city: San Francisco
country: United States
facility: Optimus Medical- Site Number : 8400046
state: California
city: San Jose
country: United States
facility: Allergy and Asthma Associates of Santa Clara Valley Research Center- Site Number : 8400038
state: California
city: Thousand Oaks
country: United States
facility: Clinical Trials Management Services - Thousand Oaks- Site Number : 8400053
state: California
city: Aurora
country: United States
facility: Allianz Research Institute CO- Site Number : 8400026
state: Colorado
city: Englewood
country: United States
facility: Velocity Clinical Research - Denver- Site Number : 8400027
state: Colorado
city: Wheat Ridge
country: United States
facility: Western States Clinical Research- Site Number : 8400014
state: Colorado
city: Cutler Bay
country: United States
facility: Beautiful Minds Clinical Research Center- Site Number : 8400049
state: Florida
city: Hialeah
country: United States
facility: Qway Research - Hialeah- Site Number : 8400015
state: Florida
city: Miami Lakes
country: United States
facility: Deluxe Health Center- Site Number : 8400045
state: Florida
city: Miami
country: United States
facility: Clintex Research Group - Miami - Coral Way- Site Number : 8400048
state: Florida
city: Miami
country: United States
facility: High Quality Research- Site Number : 8400039
state: Florida
city: Miami
country: United States
facility: Innovations Biotech- Site Number : 8400040
state: Florida
city: Miami
country: United States
facility: New Access Medical Center- Site Number : 8400043
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute - New Port Richey- Site Number : 8400044
state: Florida
city: Pembroke Pines
country: United States
facility: Pines Care Research Center- Site Number : 8400057
state: Florida
city: Sarasota
country: United States
facility: Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400019
state: Florida
city: Calhoun
country: United States
facility: Appalachian Clinical Research- Site Number : 8400050
state: Georgia
city: Champaign
country: United States
facility: PMG Research of Christie Clinic- Site Number : 8400066
state: Illinois
city: Lafayette
country: United States
facility: Velocity Clinical Research Lafayette Site Number : 8400060
state: Louisiana
city: Annapolis
country: United States
facility: Javara - Privia Medical Group - Annapolis- Site Number : 8400033
state: Maryland
city: Boston
country: United States
facility: Brigham & Women's Hospital- Site Number : 8400034
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System - Ann Arbor- Site Number : 8400004
state: Michigan
city: Mankato
country: United States
facility: Javara - Mankato Clinic- Site Number : 8400051
state: Minnesota
city: Saint Louis
country: United States
facility: Midwest Clinical Research Center - St. Louis- Site Number : 8400006
state: Missouri
city: Middletown
country: United States
facility: Circuit Clinical - Middletown Medical - 111 Maltese Drive- Site Number : 8400065
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai- Site Number : 8400058
state: New York
city: Charlotte
country: United States
facility: Carolina Clinical Research - Charlotte- Site Number : 8400071
state: North Carolina
city: Charlotte
country: United States
facility: Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400029
state: North Carolina
city: Gastonia
country: United States
facility: Clinical Research Of Gastonia- Site Number : 8400013
state: North Carolina
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center- Site Number : 8400016
state: Ohio
city: Toledo
country: United States
facility: Asthma & Allergy Center - Toledo- Site Number : 8400017
state: Ohio
city: Edmond
country: United States
facility: OK Clinical Research- Site Number : 8400021
state: Oklahoma
city: Medford
country: United States
facility: Velocity Clinical Research - Medford- Site Number : 8400059
state: Oregon
city: DuBois
country: United States
facility: Clinical Research Associates of Central PA - Dubois- Site Number : 8400069
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400007
state: Pennsylvania
city: Pottstown
country: United States
facility: Circuit Clinical - PMSI Comprehensive Healthcare for Life - Pottstown - Medical Drive- Site Number : 8400064
state: Pennsylvania
city: Anderson
country: United States
facility: VitaLink Research - Anderson - East Greenville- Site Number : 8400063
state: South Carolina
city: Charleston
country: United States
facility: Velocity Clinical Research - Charleston- Site Number : 8400061
state: South Carolina
city: Austin
country: United States
facility: Orion Clinical Research- Site Number : 8400001
state: Texas
city: Boerne
country: United States
facility: South Texas Medical Research Institute - TTS Research- Site Number : 8400010
state: Texas
city: Dallas
country: United States
facility: Baylor University Medical Center- Site Number : 8400002
state: Texas
city: El Paso
country: United States
facility: Western Sky Medical Research- Site Number : 8400023
state: Texas
city: McKinney
country: United States
facility: Metroplex Pulmonary and Sleep Center- Site Number : 8400022
state: Texas
city: Plano
country: United States
facility: VAST Clinical Research- Site Number : 8400062
state: Texas
city: Berazategui
country: Argentina
facility: Investigational Site Number : 0320007
state: Buenos Aires
city: La Plata
country: Argentina
facility: Investigational Site Number : 0320003
state: Buenos Aires
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320002
state: Santa Fe
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320006
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320005
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320004
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320001
city: Mendoza
country: Argentina
facility: Investigational Site Number : 0320009
city: San Miguel de Tucumán
country: Argentina
facility: Investigational Site Number : 0320008
city: Santa Fe
country: Argentina
facility: Investigational Site Number : 0320010
city: Salvador
country: Brazil
facility: Associacao Proar- Site Number : 0760003
state: Bahia
city: Goiânia
country: Brazil
facility: Universidade Federal de Goias- Site Number : 0760007
state: Goiás
city: Curitiba
country: Brazil
facility: Centro de Estudos em Terapias Inovadoras- Site Number : 0760002
state: Paraná
city: Recife
country: Brazil
facility: Inst de Medicina Integral Professor Fernando Figueira- Site Number : 0760009
state: Pernambuco
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001
state: Rio Grande Do Sul
city: Blumenau
country: Brazil
facility: Hospital Dia do Pulmão- Site Number : 0760005
state: Santa Catarina
city: Rio de Janeiro
country: Brazil
facility: CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760006
city: São Paulo
country: Brazil
facility: Incor - Instituto do Coracao- Site Number : 0760011
city: Hamilton
country: Canada
facility: Investigational Site Number : 1240003
state: Ontario
city: Stoney Creek
country: Canada
facility: Investigational Site Number : 1240005
state: Ontario
city: Sherbrooke
country: Canada
facility: Investigational Site Number : 1240004
state: Quebec
city: Trois-rivières
country: Canada
facility: Investigational Site Number : 1240001
state: Quebec
city: Valdivia
country: Chile
facility: Investigational Site Number : 1520010
state: Los Ríos
city: Talca
country: Chile
facility: Investigational Site Number : 1520001
state: Maule
city: Santiago
country: Chile
facility: Investigational Site Number : 1520006
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520005
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520004
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520009
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520002
state: Reg Metropolitana De Santiago
city: Quillota
country: Chile
facility: Investigational Site Number : 1520008
state: Valparaíso
city: Viña Del Mar
country: Chile
facility: Investigational Site Number : 1520011
state: Valparaíso
city: Beijing
country: China
facility: Investigational Site Number : 1560011
city: Changchun
country: China
facility: Investigational Site Number : 1560010
city: Changsha
country: China
facility: Investigational Site Number : 1560017
city: Chengdu
country: China
facility: Investigational Site Number : 1560008
city: Guangzhou
country: China
facility: Investigational Site Number : 1560001
city: Guangzhou
country: China
facility: Investigational Site Number : 1560009
city: Hefei
country: China
facility: Investigational Site Number : 1560006
city: Hohhot
country: China
facility: Investigational Site Number : 1560014
city: Mianyang
country: China
facility: Investigational Site Number : 1560018
city: Nanchang
country: China
facility: Investigational Site Number : 1560007
city: Pingxiang
country: China
facility: Investigational Site Number : 1560002
city: Shanghai
country: China
facility: Investigational Site Number : 1560013
city: Shenyang
country: China
facility: Investigational Site Number : 1560015
city: Wenzhou
country: China
facility: Investigational Site Number : 1560005
city: Wuhan
country: China
facility: Investigational Site Number : 1560003
city: Xuzhou
country: China
facility: Investigational Site Number : 1560004
city: Yangzhou
country: China
facility: Investigational Site Number : 1560016
city: Zhanjiang
country: China
facility: Investigational Site Number : 1560012
city: Coimbatore
country: India
facility: Investigational Site Number : 3560002
city: Delhi
country: India
facility: Investigational Site Number : 3560006
city: Hyderabad
country: India
facility: Investigational Site Number : 3560009
city: Kanpur
country: India
facility: Investigational Site Number : 3560008
city: Kozhikode
country: India
facility: Investigational Site Number : 3560007
city: Lucknow
country: India
facility: Investigational Site Number : 3560003
city: Nagpur
country: India
facility: Investigational Site Number : 3560001
city: Pune
country: India
facility: Investigational Site Number : 3560004
city: Ashkelon
country: Israel
facility: Investigational Site Number : 3760006
city: Haifa
country: Israel
facility: Investigational Site Number : 3760001
city: Haifa
country: Israel
facility: Investigational Site Number : 3760008
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 : 3760010
city: Ramat Gan
country: Israel
facility: Investigational Site Number : 3760009
city: Rehovot
country: Israel
facility: Investigational Site Number : 3760004
city: Tel Aviv
country: Israel
facility: Investigational Site Number : 3760007
city: Kamogawa
country: Japan
facility: Investigational Site Number : 3920004
state: Chiba
city: Sakaide
country: Japan
facility: Investigational Site Number : 3920002
state: Kagawa
city: Yokohama
country: Japan
facility: Investigational Site Number : 3920010
state: Kanagawa
city: Chuo
country: Japan
facility: Investigational Site Number : 3920011
state: Tokyo
city: UBE
country: Japan
facility: Investigational Site Number : 3920005
state: Yamaguchi
city: Fukushima
country: Japan
facility: Investigational Site Number : 3920008
city: Higashiomi
country: Japan
facility: Investigational Site Number : 3920003
city: Kyoto
country: Japan
facility: Investigational Site Number : 3920006
city: Kyoto
country: Japan
facility: Investigational Site Number : 3920009
city: Miyazaki
country: Japan
facility: Investigational Site Number : 3920012
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100002
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100001
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100004
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100006
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100003
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100005
city: Guadalajara
country: Mexico
facility: Investigational Site Number : 4840001
state: Jalisco
city: Monterrey
country: Mexico
facility: Investigational Site Number : 4840004
state: Nuevo León
city: San Juan Del Río
country: Mexico
facility: Investigational Site Number : 4840005
state: Querétaro
city: Chihuahua
country: Mexico
facility: Investigational Site Number : 4840002
city: Durango
country: Mexico
facility: Investigational Site Number : 4840003
city: Mérida
country: Mexico
facility: Investigational Site Number : 4840007
city: Veracruz
country: Mexico
facility: Investigational Site Number : 4840008
city: Benoni
country: South Africa
facility: Investigational Site Number : 7100004
city: Benoni
country: South Africa
facility: Investigational Site Number : 7100005
city: Cape Town
country: South Africa
facility: Investigational Site Number : 7100003
city: Cape Town
country: South Africa
facility: Investigational Site Number : 7100002
city: Durban
country: South Africa
facility: Investigational Site Number : 7100001
city: Lochner ROAD
country: South Africa
facility: Investigational Site Number : 7100006
city: Akdeniz
country: Turkey
facility: Investigational Site Number : 7920001
city: Bursa
country: Turkey
facility: Investigational Site Number : 7920006
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920002
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920003
city: Izmir
country: Turkey
facility: Investigational Site Number : 7920004
city: Izmit
country: Turkey
facility: Investigational Site Number : 7920005
city: Kayseri
country: Turkey
facility: Investigational Site Number : 7920007
city: Cambridge
country: United Kingdom
facility: Investigational Site Number : 8260001
state: Cambridgeshire
city: Glasgow
country: United Kingdom
facility: Investigational Site Number : 8260004
state: Edinburgh, City Of
city: Chertsey
country: United Kingdom
facility: Investigational Site Number : 8260005
state: Surrey
city: Birmingham
country: United Kingdom
facility: Investigational Site Number : 8260003
city: Bradford
country: United Kingdom
facility: Investigational Site Number : 8260008
city: Bristol
country: United Kingdom
facility: Investigational Site Number : 8260009
Study officials:
affiliation: Sanofi
name: Clinial Science & Operations
role: STUDY_DIRECTOR
References: