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

Status: Recruiting
Location: See all (222) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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).

Locations
United States
Alabama
The Center for Clinical Trials, Inc.- Site Number : 8400096
RECRUITING
Saraland
Arizona
Chandler Clinical Research Trials- Site Number : 8400075
RECRUITING
Chandler
Epic Medical Research- Site Number : 8400052
RECRUITING
Sun City
Tucson Clinical Research Institute- Site Number : 8400085
RECRUITING
Tucson
California
Allergy & Rheumatology- Site Number : 8400021
RECRUITING
La Jolla
Velocity Clinical Research- Site Number : 8400024
RECRUITING
La Mesa
Ark Clinical Research- Site Number : 8400097
RECRUITING
Long Beach
Downtown LA Research Center Inc.- Site Number : 8400080
RECRUITING
Los Angeles
Carbon Health-North Hollywood Clinic- Site Number : 8400061
RECRUITING
North Hollywood
Carbon Health - San Mateo CA Urgent Care & Primary Care- Site Number : 8400062
RECRUITING
San Mateo
Modena Allergy + Asthma Torrance- Site Number : 8400068
RECRUITING
Torrance
Florida
Helix Biomedics, LLC - Site Number : 8400005
RECRUITING
Boynton Beach
Beautiful Minds Clinical Research Center- Site Number : 8400019
RECRUITING
Cutler Bay
Alfa Medical Research- Site Number : 8400071
RECRUITING
Davie
Omega Research - Site Number : 8400082
RECRUITING
Debary
Royal Clinical Trials- Site Number : 8400067
RECRUITING
Inverness
D&H Pompano Research Center- Site Number : 8400072
RECRUITING
Margate
Innovations Biotech- Site Number : 8400044
RECRUITING
Miami
Research Institute of South Florida - Site Number : 8400023
RECRUITING
Miami
Oviedo Medical Research - Site number: 8400091
RECRUITING
Oviedo
Tellabio International Research Services- Site Number : 8400083
RECRUITING
Pembroke Pines
Avanza Medical Research Center- Site Number : 8400056
RECRUITING
Pensacola
Broward Pulmonary and Sleep Specialists- Site Number : 8400079
RECRUITING
Plantation
Ilumina Medical Research- Site Number : 8400095
RECRUITING
Saint Cloud
Premier Medical Associates- Site Number : 8400077
RECRUITING
The Villages
Georgia
National Clinical Trials- Site Number : 8400081
RECRUITING
Cordele
Illinois
Christie Clinic on University- Site Number : 8400003
RECRUITING
Champaign
Maryland
Velocity Clinical Research, Rockville- Site Number : 8400036
RECRUITING
Rockville
Javara Inc/Privia Medical Group, PLLC- Site Number : 8400042
RECRUITING
Silver Spring
Michigan
University of Michigan Hospital - 1500 E Medical Center Dr- Site Number : 8400014
RECRUITING
Ann Arbor
Profound Research LLC at Clarkston Medical Group- Site Number : 8400054
RECRUITING
Clarkston
Minnesota
Javara Inc/Mankato Clinic,- Site Number : 8400001
RECRUITING
Mankato
Mayo Clinic- Site Number : 8400057
RECRUITING
Rochester
Missouri
Hannibal Regional Healthcare System-HRMG-Hannibal- Site Number : 8400078
RECRUITING
Hannibal
North Carolina
Piedmont Healthcare- Site Number : 8400064
RECRUITING
Statesville
New York
Icahn School of Medicine at Mount Sinai - Mount Sinai Health System- Site Number : 8400069
RECRUITING
New York
Pioneer Clinical NY- Site Number : 8400092
RECRUITING
New York
Ohio
Toledo Institute of Clinical Research- Site Number : 8400020
RECRUITING
Toledo
Oklahoma
OK Clinical Research, LLC- Site Number : 8400060
RECRUITING
Edmond
Pennsylvania
Clinical Research Associates of Central PA - Dubois- Site Number : 8400013
RECRUITING
Dubois
South Carolina
ADAC Research, PA- Site Number : 8400070
RECRUITING
Greenville
Texas
Orion Clinical Research
RECRUITING
Austin
South Texas Medical Research Institute, Inc., DBA TTS Research- Site Number : 8400015
RECRUITING
Boerne
Epic Medical Research- Site Number : 8400051
RECRUITING
Desoto
Axsendo Clinical Research of Houston- Site Number : 8400065
RECRUITING
Houston
Radiance Clinical Research
RECRUITING
Lampasas
Metroplex Pulmonary and Sleep Center- Site Number : 8400012
RECRUITING
Mckinney
BFHC Research- Site Number : 8400049
RECRUITING
San Antonio
STAAMP Research LLC- Site Number : 8400059
RECRUITING
San Antonio
Javara Inc/Privia Medical Group Gulf Coast, PLLC- Site Number : 8400040
RECRUITING
San Marcos
Javara Inc/Privia Medical Group North Texas, PLLC- Site Number : 8400038
RECRUITING
Stephenville
Simcare Medical Research- Site Number : 8400102
RECRUITING
Sugar Land
Other Locations
Argentina
Investigational Site Number : 0320007
RECRUITING
Berazategui
Investigational Site Number : 0320005
RECRUITING
Buenos Aires
Investigational Site Number : 0320004
RECRUITING
Caba
Investigational Site Number : 0320012
RECRUITING
Caba
Investigational Site Number : 0320001
RECRUITING
Ciudad Autonoma Buenos Aires
Investigational Site Number : 0320002
RECRUITING
Ciudad Autonoma Buenos Aires
Investigational Site Number : 0320008
RECRUITING
Corrientes
Investigational Site Number : 0320011
RECRUITING
La Plata
Investigational Site Number : 0320013
RECRUITING
Lobos
Investigational Site Number : 0320014
RECRUITING
Mendoza
Investigational Site Number : 0320015
RECRUITING
Mendoza
Investigational Site Number : 0320006
RECRUITING
Rosario
Investigational Site Number : 0320010
RECRUITING
Rosario
Investigational Site Number : 0320016
RECRUITING
Rosario
Investigational Site Number : 0320003
RECRUITING
San Miguel De Tucumán
Investigational Site Number : 0320009
RECRUITING
Santa Fe
Belgium
Investigational Site Number : 0560001
RECRUITING
Ghent
Investigational Site Number : 0560003
RECRUITING
Liège
Investigational Site Number : 0560002
RECRUITING
Mechelen
Brazil
HCPR - Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760006
RECRUITING
Curitiba
HC UFG - Hospital Das Clinicas de Goias- Site Number : 0760011
RECRUITING
Goiânia
Hospital Sao Lucas da PUCRS- Site Number : 0760001
RECRUITING
Porto Alegre
WM Clinica Pneumologica- Site Number : 0760003
RECRUITING
Porto Alegre
Proar- Site Number : 0760002
RECRUITING
Salvador
InCor - Instituto do Coraçao do Hospital das Clinicas da FMUSP- Site Number : 0760004
RECRUITING
São Paulo
Canada
Investigational Site Number : 1240013
RECRUITING
Ajax
Investigational Site Number : 1240003
RECRUITING
Guelph
Investigational Site Number : 1240011
RECRUITING
Kelowna
Investigational Site Number : 1240014
RECRUITING
Montreal
Investigational Site Number : 1240012
RECRUITING
North Vancouver
Investigational Site Number : 1240002
RECRUITING
Sherbrooke
Investigational Site Number : 1240006
RECRUITING
Stoney Creek
Investigational Site Number : 1240008
RECRUITING
Toronto
Chile
Investigational Site Number : 1520008
RECRUITING
Concepción
Investigational Site Number : 1520005
RECRUITING
Quillota
Investigational Site Number : 1520001
RECRUITING
Santiago
Investigational Site Number : 1520003
RECRUITING
Santiago
Investigational Site Number : 1520006
RECRUITING
Santiago
Investigational Site Number : 1520009
RECRUITING
Santiago
Investigational Site Number : 1520010
RECRUITING
Santiago
Investigational Site Number : 1520002
RECRUITING
Talca
Investigational Site Number : 1520011
RECRUITING
Talcahuano
Investigational Site Number : 1520004
RECRUITING
Viña Del Mar
Investigational Site Number : 1520007
RECRUITING
Viña Del Mar
China
Investigational Site Number : 1560027
RECRUITING
Beijing
Investigational Site Number : 1560005
RECRUITING
Changchun
Investigational Site Number : 1560021
RECRUITING
Chengde
Investigational Site Number : 1560039
RECRUITING
Chengdu
Investigational Site Number : 1560028
RECRUITING
Foshan
Investigational Site Number : 1560010
RECRUITING
Guangzhou
Investigational Site Number : 1560033
RECRUITING
Guangzhou
Investigational Site Number : 1560037
RECRUITING
Guiyang
Investigational Site Number : 1560042
RECRUITING
Hangzhou
Investigational Site Number : 1560040
RECRUITING
Hefei
Investigational Site Number : 1560006
RECRUITING
Hohhot
Investigational Site Number : 1560007
RECRUITING
Hohhot
Investigational Site Number : 1560011
RECRUITING
Huizhou
Investigational Site Number : 1560029
RECRUITING
Huizhou
Investigational Site Number : 1560034
RECRUITING
Jinan
Investigational Site Number : 1560038
RECRUITING
Jinan
Investigational Site Number : 1560030
RECRUITING
Lanzhou
Investigational Site Number : 1560018
RECRUITING
Luoyang
Investigational Site Number : 1560003
RECRUITING
Nanchang
Investigational Site Number : 1560014
RECRUITING
Ningbo
Investigational Site Number : 1560001
RECRUITING
Shanghai
Investigational Site Number : 1560043
RECRUITING
Shanghai
Investigational Site Number : 1560016
RECRUITING
Shenyang
Investigational Site Number : 1560009
RECRUITING
Shijiazhuang
Investigational Site Number : 1560025
RECRUITING
Shijiazhuang
Investigational Site Number : 1560008
RECRUITING
Suzhou
Investigational Site Number : 1560019
RECRUITING
Suzhou
Investigational Site Number : 1560017
RECRUITING
Taiyuan
Investigational Site Number : 1560035
RECRUITING
Taiyuan
Investigational Site Number : 1560002
RECRUITING
Tianjin
Investigational Site Number : 1560013
RECRUITING
Tianjin
Investigational Site Number : 1560022
RECRUITING
Wuhan
Investigational Site Number : 1560032
RECRUITING
Xi'an
Investigational Site Number : 1560036
RECRUITING
Xi'an
Investigational Site Number : 1560044
RECRUITING
Xianyang
Investigational Site Number : 1560012
RECRUITING
Xuzhou
Investigational Site Number : 1560047
RECRUITING
Yangzhou
Investigational Site Number : 1560023
RECRUITING
Zhengzhou
Investigational Site Number : 1560026
RECRUITING
Zhengzhou
Investigational Site Number : 1560045
RECRUITING
Zigong
Denmark
Investigational Site Number : 2080001
RECRUITING
Hvidovre
Investigational Site Number : 2080002
RECRUITING
Vejle
France
Investigational Site Number : 2500007
RECRUITING
Amiens
Investigational Site Number : 2500004
RECRUITING
Lyon
Investigational Site Number : 2500003
RECRUITING
Montpellier
Investigational Site Number : 2500006
RECRUITING
Paris
Investigational Site Number : 2500005
RECRUITING
Pessac
Investigational Site Number : 2500001
RECRUITING
Strasbourg
Investigational Site Number : 2500002
RECRUITING
Toulouse
Germany
Investigational Site Number : 2760006
RECRUITING
Ahrensburg
Investigational Site Number : 2760002
RECRUITING
Bendorf
Investigational Site Number : 6420001
RECRUITING
Düsseldorf
Investigational Site Number : 2760004
RECRUITING
Frankfurt Am Main
Investigational Site Number : 2760001
RECRUITING
Leipzig
Investigational Site Number : 2760005
RECRUITING
Mainz
Hungary
Investigational Site Number : 3480006
RECRUITING
Debrecen
Investigational Site Number : 3480002
RECRUITING
Gödöllö
Investigational Site Number : 3480003
RECRUITING
Hajdúnánás
Investigational Site Number : 3480004
RECRUITING
Mosonmagyaróvár
Investigational Site Number : 3480005
RECRUITING
Pécs
Investigational Site Number : 3480001
RECRUITING
Püspökladány
Israel
Investigational Site Number : 3760006
RECRUITING
Haifa
Investigational Site Number : 3760002
RECRUITING
Jerusalem
Investigational Site Number : 3760003
RECRUITING
Jerusalem
Investigational Site Number : 3760005
RECRUITING
Petah Tikva
Investigational Site Number : 3760001
RECRUITING
Rehovot
Investigational Site Number : 3760004
RECRUITING
Tel Aviv
Italy
Investigational Site Number : 3800008
RECRUITING
Ancona
Investigational Site Number : 3800007
RECRUITING
Bergamo
Investigational Site Number : 3800001
RECRUITING
Cona (ferrara)
Investigational Site Number : 3800009
RECRUITING
Genova
Investigational Site Number : 3800004
RECRUITING
Milan
Investigational Site Number : 3800005
RECRUITING
Modena
Investigational Site Number : 3800006
RECRUITING
Monserrato
Investigational Site Number : 3800013
RECRUITING
Palermo
Investigational Site Number : 3800011
RECRUITING
Reggio Emilia
Investigational Site Number : 3800010
RECRUITING
Rome
Investigational Site Number : 3800003
RECRUITING
Rozzano
Investigational Site Number : 3800012
RECRUITING
Tradate
Poland
Investigational Site Number : 6160002
RECRUITING
Bialystok
Investigational Site Number : 6160004
RECRUITING
Chęciny
Investigational Site Number : 6160009
RECRUITING
Katowice
Investigational Site Number : 6160008
RECRUITING
Lodz
Investigational Site Number : 6160003
RECRUITING
Ostrowiec Świętokrzyski
Investigational Site Number : 6160001
RECRUITING
Poznan
Investigational Site Number : 6160005
RECRUITING
Poznan
Romania
Investigational Site Number : 6420002
RECRUITING
Cluj-napoca
South Africa
Investigational Site Number : 7100004
RECRUITING
Benoni
Investigational Site Number : 7100005
RECRUITING
Benoni
Investigational Site Number : 7100002
RECRUITING
Cape Town
Investigational Site Number : 7100003
RECRUITING
Durban
Investigational Site Number : 7100006
RECRUITING
Durban
Investigational Site Number : 7100007
RECRUITING
Johannesburg
Spain
Investigational Site Number : 7240010
RECRUITING
Badalona
Investigational Site Number : 7240009
RECRUITING
Barcelona
Investigational Site Number : 7240015
RECRUITING
Barcelona
Investigational Site Number : 7240016
RECRUITING
Girona
Investigational Site Number : 7240002
RECRUITING
Madrid
Investigational Site Number : 7240007
RECRUITING
Madrid
Investigational Site Number : 7240011
RECRUITING
Madrid
Investigational Site Number : 7240013
RECRUITING
Madrid
Investigational Site Number : 7240008
RECRUITING
Madrid / Madrid
Investigational Site Number : 7240004
RECRUITING
Málaga
Investigational Site Number : 7240006
RECRUITING
Málaga
Investigational Site Number : 7240001
RECRUITING
Palma De Mallorca
Investigational Site Number : 7240005
RECRUITING
Santiago De Compostela
Investigational Site Number : 7240014
RECRUITING
Seville
Sweden
Investigational Site Number : 7520003
RECRUITING
Gothenburg
Investigational Site Number : 7520002
RECRUITING
Lund
Investigational Site Number : 7520001
RECRUITING
Stockholm
Taiwan
Investigational Site Number : 1580002
RECRUITING
Hualien City
Investigational Site Number : 1580005
RECRUITING
Kaohsiung City
Investigational Site Number : 1580006
RECRUITING
Taichung
Investigational Site Number : 1580007
RECRUITING
Taichung
Investigational Site Number : 1580003
RECRUITING
Taipei
Investigational Site Number : 1580004
RECRUITING
Taipei
Investigational Site Number : 1580001
RECRUITING
Taoyuan
Turkey
Investigational Site Number : 7920003
RECRUITING
Kayseri
Investigational Site Number : 7920002
RECRUITING
Kırıkkale
Investigational Site Number : 7920001
RECRUITING
Mersin
United Kingdom
Investigational Site Number : 8260005
RECRUITING
Barnsley
Investigational Site Number : 8260003
RECRUITING
Bradford
Investigational Site Number : 8260007
RECRUITING
Corby
Investigational Site Number : 8260001
RECRUITING
London
Investigational Site Number : 8260006
RECRUITING
Nottingham
Investigational Site Number : 8260008
RECRUITING
Oxford
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2024-11-07
Estimated Completion Date: 2027-11-12
Participants
Target number of participants: 1000
Treatments
Experimental: Lunsekimig
Participants will receive lunsekimig (SC injection) every 4 weeks
Placebo_comparator: Placebo
Participants will receive placebo (SC injection) every 4 weeks
Related Therapeutic Areas
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov

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