Undersøgelse af Lunsekimig (SAR443765) sammenlignet med placebo hos voksne med højrisiko astma (AIRLYMPUS)
20. september 2026 opdateret af: Sanofi
Et randomiseret, fase 2, dobbeltblindt, placebokontrolleret, parallelgruppe, 2-armsstudie til undersøgelse af effektiviteten, sikkerheden og tolerabiliteten af subkutan Lunsekimig (SAR443765) hos voksne deltagere med højrisiko-astma, som ikke i øjeblikket er kvalificerede til biologisk behandling
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 subcutaneous (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.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
556
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Buenos Aires, Argentina, 1121
- Investigational Site Number : 0320005
-
Buenos Aires, Argentina, 1425
- Investigational Site Number : 0320001
-
Buenos Aires, Argentina, 1425
- Investigational Site Number : 0320004
-
Buenos Aires, Argentina, 1122
- Investigational Site Number : 0320012
-
Buenos Aires, Argentina, 1414
- Investigational Site Number : 0320002
-
Corrientes, Argentina, 3400
- Investigational Site Number : 0320008
-
La Plata, Buenos Aires, Argentina, B1904CUL
- Investigational Site Number : 0320011
-
Mendoza, Argentina, 5500
- Investigational Site Number : 0320015
-
Mendoza, Argentina, 5500
- Investigational Site Number : 0320014
-
Santa Fe, Argentina, 3000
- Investigational Site Number : 0320009
-
-
Buenos Aires
-
Berazategui, Buenos Aires, Argentina, 1886
- Investigational Site Number : 0320007
-
Lobos, Buenos Aires, Argentina, 7240
- Investigational Site Number : 0320013
-
-
Santa Fe Province
-
Rosario, Santa Fe Province, Argentina, 2000
- Investigational Site Number : 0320006
-
Rosario, Santa Fe Province, Argentina, 2000
- Investigational Site Number : 0320010
-
Rosario, Santa Fe Province, Argentina, 2000
- Investigational Site Number : 0320016
-
-
Tucumán Province
-
San Miguel de Tucumán, Tucumán Province, Argentina, 4000
- Investigational Site Number : 0320003
-
-
-
-
-
Liège, Belgien, 4000
- Investigational Site Number : 0560003
-
Mechelen, Belgien, 2800
- Investigational Site Number : 0560002
-
-
-
-
-
São Paulo, Brasilien, 05403-000
- Incor - Instituto do Coracao- Site Number : 0760004
-
-
Estado de Bahia
-
Salvador, Estado de Bahia, Brasilien, 40060-330
- Associacao Proar- Site Number : 0760002
-
-
Goiás
-
Goiânia, Goiás, Brasilien, 74605-020
- Universidade Federal de Goias- Site Number : 0760011
-
-
Paraná
-
Curitiba, Paraná, Brasilien, 80060-900
- Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760006
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brasilien, 90610-000
- Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001
-
Porto Alegre, Rio Grande do Sul, Brasilien, 91010-006
- WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760003
-
-
-
-
British Columbia
-
Kelowna, British Columbia, Canada, V1Y 4N7
- Investigational Site Number : 1240011
-
West Vancouver, British Columbia, Canada, V7T 2Z3
- Investigational Site Number : 1240012
-
-
Ontario
-
Ajax, Ontario, Canada, L1S 2J5
- Investigational Site Number : 1240013
-
Guelph, Ontario, Canada, N1h 6j2
- Investigational Site Number : 1240003
-
Stoney Creek, Ontario, Canada, L8G 2V6
- Investigational Site Number : 1240006
-
Toronto, Ontario, Canada, M4G 3E8
- Investigational Site Number : 1240008
-
-
Quebec
-
Montreal, Quebec, Canada, H2X 3E4
- Investigational Site Number : 1240014
-
Sherbrooke, Quebec, Canada, J1H 5N4
- Investigational Site Number : 1240002
-
-
-
-
Biobio
-
Concepción, Biobio, Chile, 4070094
- Investigational Site Number : 1520008
-
-
Maule Region
-
Talca, Maule Region, Chile, 3465584
- Investigational Site Number : 1520002
-
-
Reg Metropolitana de Santiago
-
Lo Barnechea, Reg Metropolitana de Santiago, Chile, 7691236
- Investigational Site Number : 1520009
-
Recoleta, Reg Metropolitana de Santiago, Chile, 8420000
- Investigational Site Number : 1520010
-
Santiago, Reg Metropolitana de Santiago, Chile, 7500692
- Investigational Site Number : 1520001
-
Santiago, Reg Metropolitana de Santiago, Chile, 7500698
- Investigational Site Number : 1520003
-
Santiago, Reg Metropolitana de Santiago, Chile, 7500587
- Investigational Site Number : 1520006
-
-
Valparaiso
-
Quillota, Valparaiso, Chile, 2260877
- Investigational Site Number : 1520005
-
Viña del Mar, Valparaiso, Chile, 2540364
- Investigational Site Number : 1520007
-
Viña del Mar, Valparaiso, Chile, 2531172
- Investigational Site Number : 1520004
-
-
-
-
-
Hvidovre, Danmark, 2650
- Investigational Site Number : 2080001
-
Vejle, Danmark, 7100
- Investigational Site Number : 2080002
-
-
-
-
-
Barnsley, Det Forenede Kongerige, S75 2EP
- Investigational Site Number : 8260005
-
Bradford, Det Forenede Kongerige, BD9 6DA
- Investigational Site Number : 8260003
-
London, Det Forenede Kongerige, W1G 8HU
- Investigational Site Number : 8260001
-
-
Hillingdon
-
Ruislip, Hillingdon, Det Forenede Kongerige, HA4 8NX
- Investigational Site Number : 8260009
-
-
Northamptonshire
-
Corby, Northamptonshire, Det Forenede Kongerige, NN17 2UN
- Investigational Site Number : 8260007
-
-
Nottinghamshire
-
Nottingham, Nottinghamshire, Det Forenede Kongerige, NG7 2UH
- Investigational Site Number : 8260006
-
-
Oxfordshire
-
Oxford, Oxfordshire, Det Forenede Kongerige, OX3 9DU
- Investigational Site Number : 8260008
-
-
-
-
Alabama
-
Saraland, Alabama, Forenede Stater, 36571
- The Center for Clinical Trials - Saraland- Site Number : 8400096
-
-
Arizona
-
Chandler, Arizona, Forenede Stater, 85224
- Chandler Clinical Research Trials- Site Number : 8400075
-
Sun City, Arizona, Forenede Stater, 85351
- Epic Medical Research - Sun City- Site Number : 8400052
-
Tucson, Arizona, Forenede Stater, 85712
- Tucson Clinical Research Institute- Site Number : 8400085
-
-
California
-
Long Beach, California, Forenede Stater, 90815
- Ark Clinical Research- Site Number : 8400097
-
Los Angeles, California, Forenede Stater, 90017
- Downtown L.A. Research Center- Site Number : 8400080
-
North Hollywood, California, Forenede Stater, 91606
- Carbon Health - North Hollywood - NoHo West- Site Number : 8400061
-
San Mateo, California, Forenede Stater, 94403
- Carbon Health - San Mateo - Hillsdale Mall- Site Number : 8400062
-
Stanford, California, Forenede Stater, 94305
- Stanford University Medical Center- Site Number : 8400108
-
Torrance, California, Forenede Stater, 90505
- Modena Allergy And Asthma- Site Number : 8400068
-
-
District of Columbia
-
Washington D.C., District of Columbia, Forenede Stater, 20060
- Howard University Hospital- Site Number : 8400107
-
-
Florida
-
Boynton Beach, Florida, Forenede Stater, 33435
- Helix Biomedics- Site Number : 8400005
-
Cutler Bay, Florida, Forenede Stater, 33157
- Beautiful Minds Clinical Research Center- Site Number : 8400019
-
DeBary, Florida, Forenede Stater, 32713
- Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400082
-
Hollywood, Florida, Forenede Stater, 33024
- Alfa Medical Research- Site Number : 8400071
-
Inverness, Florida, Forenede Stater, 34453
- Royal Clinical Trials - Inverness- Site Number : 8400067
-
Lady Lake, Florida, Forenede Stater, 32159
- Premier Medical Associates- Site Number : 8400077
-
Margate, Florida, Forenede Stater, 33063
- D&H Pompano Research Center- Site Number : 8400072
-
Miami, Florida, Forenede Stater, 33173
- Research Institute of South Florida- Site Number : 8400023
-
Miami, Florida, Forenede Stater, 33186
- Innovations Biotech- Site Number : 8400044
-
Pembroke Pines, Florida, Forenede Stater, 33025
- Tellabio International Research Services- Site Number : 8400083
-
Pensacola, Florida, Forenede Stater, 32503
- Avanza Medical Research Center- Site Number : 8400056
-
Saint Cloud, Florida, Forenede Stater, 34769
- Ilumina Medical Research- Site Number : 8400095
-
-
Georgia
-
Cordele, Georgia, Forenede Stater, 31015
- Private Practice - Dr. David Kavtaradze- Site Number : 8400081
-
Riverdale, Georgia, Forenede Stater, 30274
- EmVenio Research - Riverdale- Site Number : 8400109
-
-
Illinois
-
Champaign, Illinois, Forenede Stater, 61820
- Christie Clinic in Champaign on University- Site Number : 8400003
-
-
Kansas
-
Kansas City, Kansas, Forenede Stater, 66160
- University of Kansas Medical Center- Site Number : 8400105
-
-
Maryland
-
Rockville, Maryland, Forenede Stater, 20854
- Velocity Clinical Research - Rockville (formerly Meridian Clinical Research)- Site Number : 8400036
-
Silver Spring, Maryland, Forenede Stater, 20901
- Javara - Privia Medical Group - Silver Spring Lockwood- Site Number : 8400042
-
-
Michigan
-
Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan Health System - Ann Arbor- Site Number : 8400014
-
Clarkston, Michigan, Forenede Stater, 48346
- Clarkston Medical Group- Site Number : 8400054
-
-
Minnesota
-
Mankato, Minnesota, Forenede Stater, 56001
- Javara - Mankato Clinic- Site Number : 8400001
-
Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic in Rochester - Minnesota- Site Number : 8400057
-
-
Missouri
-
Hannibal, Missouri, Forenede Stater, 63401
- Hannibal Regional Healthcare System- Site Number : 8400078
-
-
New York
-
New York, New York, Forenede Stater, 10011
- Icahn School of Medicine at Mount Sinai (ISMMS) - Mount Sinai Doctors- Site Number : 8400069
-
New York, New York, Forenede Stater, 10016
- Pioneer Clinical Research - New York- Site Number : 8400092
-
-
North Carolina
-
Statesville, North Carolina, Forenede Stater, 28625
- Piedmont Healthcare - Family Medicine- Site Number : 8400064
-
-
Ohio
-
Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic - Cleveland- Site Number : 8400106
-
Toledo, Ohio, Forenede Stater, 43617
- Asthma & Allergy Center - Toledo- Site Number : 8400020
-
-
Oklahoma
-
Edmond, Oklahoma, Forenede Stater, 73034
- OK Clinical Research- Site Number : 8400060
-
-
Pennsylvania
-
DuBois, Pennsylvania, Forenede Stater, 15801
- Clinical Research Associates of Central Pennsylvania- Site Number : 8400013
-
Philadelphia, Pennsylvania, Forenede Stater, 19107
- Thomas Jefferson University Hospital- Site Number : 8400110
-
-
South Carolina
-
Greenville, South Carolina, Forenede Stater, 29607
- Allergic Disease and Asthma Center (ADAC)- Site Number : 8400070
-
-
Texas
-
Austin, Texas, Forenede Stater, 78759
- Orion Clinical Research- Site Number : 8400084
-
Boerne, Texas, Forenede Stater, 78006
- South Texas Medical Research Institute - TTS Research- Site Number : 8400015
-
DeSoto, Texas, Forenede Stater, 75115
- Epic Medical Research - De Soto- Site Number : 8400051
-
Houston, Texas, Forenede Stater, 77058
- Axsendo Clinical Research - Houston- Site Number : 8400065
-
McKinney, Texas, Forenede Stater, 75069
- Metroplex Pulmonary and Sleep Center- Site Number : 8400012
-
San Antonio, Texas, Forenede Stater, 78229
- STAAMP Research - San Antonio- Site Number : 8400059
-
San Antonio, Texas, Forenede Stater, 78249
- Bandera Family Health Care - San Antonio- Site Number : 8400049
-
San Marcos, Texas, Forenede Stater, 78666
- Javara - San Marcos - Redwood Road- Site Number : 8400040
-
Sugar Land, Texas, Forenede Stater, 77478
- Simcare Medical Research- Site Number : 8400102
-
-
Wisconsin
-
Milwaukee, Wisconsin, Forenede Stater, 53226
- Children's Wisconsin- Site Number : 8400073
-
-
-
-
-
Amiens, Frankrig, 80000
- Investigational Site Number : 2500007
-
Lyon, Frankrig, 69004
- Investigational Site Number : 2500004
-
Montpellier, Frankrig, 34090
- Investigational Site Number : 2500003
-
Paris, Frankrig, 75018
- Investigational Site Number : 2500006
-
Pessac, Frankrig, 33604
- Investigational Site Number : 2500005
-
Strasbourg, Frankrig, 67000
- Investigational Site Number : 2500001
-
Toulouse, Frankrig, 31059
- Investigational Site Number : 2500002
-
-
-
-
-
Haifa, Israel, 3436212
- Investigational Site Number : 3760006
-
Jerusalem, Israel, 9103102
- Investigational Site Number : 3760003
-
Jerusalem, Israel, 9112001
- Investigational Site Number : 3760002
-
Petah Tikva, Israel, 4941492
- Investigational Site Number : 3760005
-
Rehovot, Israel, 7610001
- Investigational Site Number : 3760001
-
Tel Aviv, Israel, 6423906
- Investigational Site Number : 3760004
-
-
-
-
-
Bergamo, Italien, 24127
- Investigational Site Number : 3800007
-
Modena, Italien, 41125
- Investigational Site Number : 3800005
-
Palermo, Italien, 90127
- Investigational Site Number : 3800013
-
Reggio Emilia, Italien, 42100
- Investigational Site Number : 3800011
-
Tradate (Va), Italien, 21049
- Investigational Site Number : 3800012
-
-
Ancona
-
Torette, Ancona, Italien, 60020
- Investigational Site Number : 3800008
-
-
Cagliari
-
Monserrato, Cagliari, Italien, 09042
- Investigational Site Number : 3800006
-
-
Ferrara
-
Cona, Ferrara, Italien, 44124
- Investigational Site Number : 3800001
-
-
Genova
-
Genoa, Genova, Italien, 16132
- Investigational Site Number : 3800009
-
-
Milano
-
Milan, Milano, Italien, 20122
- Investigational Site Number : 3800004
-
Rozzano, Milano, Italien, 20089
- Investigational Site Number : 3800003
-
-
Roma
-
Rome, Roma, Italien, 00168
- Investigational Site Number : 3800010
-
-
-
-
Yamaguchi
-
Ube, Yamaguchi, Japan, 755-8505
- Investigational Site Number : 3920001
-
-
-
-
-
Beijing, Kina, 100029
- Investigational Site Number : 1560027
-
Changchun, Kina, 130021
- Investigational Site Number : 1560005
-
Chengde, Kina, 067020
- Investigational Site Number : 1560021
-
Chengdu, Kina, 611130
- Investigational Site Number : 1560039
-
Foshan, Kina, 528399
- Investigational Site Number : 1560028
-
Guangzhou, Kina, 510000
- Investigational Site Number : 1560010
-
Guangzhou, Kina, 510180
- Investigational Site Number : 1560033
-
Guiyang, Kina, 550002
- Investigational Site Number : 1560037
-
Hangzhou, Kina, 310005
- Investigational Site Number : 1560042
-
Hebei, Kina, 050051
- Investigational Site Number : 1560009
-
Hohhot, Kina, 010050
- Investigational Site Number : 1560006
-
Hohhot, Kina, 010070
- Investigational Site Number : 1560007
-
Huizhou, Kina, 516001
- Investigational Site Number : 1560029
-
Huizhou, Kina, 516002
- Investigational Site Number : 1560011
-
Jiazhuang, Kina, 050000
- Investigational Site Number : 1560025
-
Jinan, Kina, 250001
- Investigational Site Number : 1560034
-
Jinan, Kina, 250014
- Investigational Site Number : 1560038
-
Lanzhou, Kina, 730000
- Investigational Site Number : 1560030
-
Luoyang, Kina, 471003
- Investigational Site Number : 1560018
-
Nanchang, Kina, 330006
- Investigational Site Number : 1560003
-
Ningbo, Kina, 315010
- Investigational Site Number : 1560014
-
Shanghai, Kina, 200080
- Investigational Site Number : 1560001
-
Shanghai, Kina, 200433
- Investigational Site Number : 1560043
-
Shenyang, Kina, 110004
- Investigational Site Number : 1560016
-
Suzhou, Kina, 215002
- Investigational Site Number : 1560019
-
Taiyuan, Kina, 030001
- Investigational Site Number : 1560017
-
Taiyuan, Kina, 030032
- Investigational Site Number : 1560035
-
Tianjin, Kina, 300211
- Investigational Site Number : 1560013
-
Wuhan, Kina, 430030
- Investigational Site Number : 1560022
-
Xi'an, Kina, 710004
- Investigational Site Number : 1560036
-
Xi'an, Kina, 710061
- Investigational Site Number : 1560032
-
Xianyang, Kina, 712000
- Investigational Site Number : 1560044
-
Xuzhou, Kina, 221006
- Investigational Site Number : 1560012
-
Yangzhou, Kina, 225000
- Investigational Site Number : 1560047
-
Zhengzhou, Kina, 450003
- Investigational Site Number : 1560023
-
Zhengzhou, Kina, 450007
- Investigational Site Number : 1560026
-
Zigong, Kina, 643000
- Investigational Site Number : 1560045
-
-
-
-
-
Chęciny, Polen, 26-060
- Investigational Site Number : 6160004
-
Katowice, Polen, 40-600
- Investigational Site Number : 6160009
-
-
Greater Poland Voivodeship
-
Poznan, Greater Poland Voivodeship, Polen, 60-693
- Investigational Site Number : 6160001
-
Poznan, Greater Poland Voivodeship, Polen, 60-309
- Investigational Site Number : 6160005
-
-
Podlaskie Voivodeship
-
Bialystok, Podlaskie Voivodeship, Polen, 15-044
- Investigational Site Number : 6160002
-
-
Świętokrzyskie Voivodeship
-
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Polen, 27-400
- Investigational Site Number : 6160003
-
-
-
-
-
Bucharest, Rumænien, 011658
- Investigational Site Number : 6420001
-
Cluj-Napoca, Rumænien, 400006
- Investigational Site Number : 6420002
-
-
-
-
-
Girona, Spanien, 17005
- Investigational Site Number : 7240016
-
Madrid, Spanien, 28041
- Investigational Site Number : 7240002
-
Madrid, Spanien, 28003
- Investigational Site Number : 7240013
-
Madrid, Spanien, 28007
- Investigational Site Number : 7240008
-
Madrid, Spanien, 28010
- Investigational Site Number : 7240011
-
Málaga, Spanien, 29010
- Investigational Site Number : 7240006
-
Palma, Spanien, 07120
- Investigational Site Number : 7240001
-
Seville, Spanien, 41012
- Investigational Site Number : 7240014
-
-
A Coruña [La Coruña]
-
Santiago de Compostela, A Coruña [La Coruña], Spanien, 15702
- Investigational Site Number : 7240005
-
-
Barcelona [Barcelona]
-
Badalona, Barcelona [Barcelona], Spanien, 08916
- Investigational Site Number : 7240010
-
-
Cantabria
-
Santander, Cantabria, Spanien, 39008
- Investigational Site Number : 7240017
-
-
Catalunya [Cataluña]
-
Barcelona, Catalunya [Cataluña], Spanien, 08017
- Investigational Site Number : 7240009
-
Barcelona, Catalunya [Cataluña], Spanien, 08035
- Investigational Site Number : 7240015
-
-
Madrid, Comunidad de
-
Madrid, Madrid, Comunidad de, Spanien, 28046
- Investigational Site Number : 7240007
-
-
Málaga
-
Benalmádena, Málaga, Spanien, 29631
- Investigational Site Number : 7240018
-
-
-
-
-
Lund, Sverige, 221 85
- Investigational Site Number : 7520002
-
-
-
-
-
Benoni, Sydafrika, 1500
- Investigational Site Number : 7100004
-
Benoni, Sydafrika, 1500
- Investigational Site Number : 7100005
-
Cape Town, Sydafrika, 7530
- Investigational Site Number : 7100002
-
Durban, Sydafrika, 4001
- Investigational Site Number : 7100006
-
Durban, Sydafrika, 3630
- Investigational Site Number : 7100003
-
Johannesburg, Sydafrika, 1821
- Investigational Site Number : 7100007
-
-
-
-
-
Hualien City, Taiwan, 970
- Investigational Site Number : 1580002
-
Kaohsiung City, Taiwan, 80756
- Investigational Site Number : 1580005
-
Taichung, Taiwan, 404
- Investigational Site Number : 1580006
-
Taichung, Taiwan, 407
- Investigational Site Number : 1580007
-
Taipei, Taiwan, 100
- Investigational Site Number : 1580004
-
Taipei, Taiwan, 110
- Investigational Site Number : 1580003
-
Taoyuan City, Taiwan, 333
- Investigational Site Number : 1580001
-
-
-
-
-
Kayseri, Tyrkiet (Türkiye), 38039
- Investigational Site Number : 7920003
-
Kirikkale, Tyrkiet (Türkiye), 71100
- Investigational Site Number : 7920002
-
Mersin, Tyrkiet (Türkiye), 33070
- Investigational Site Number : 7920001
-
-
-
-
-
Ahrensburg, Tyskland, 22926
- Investigational Site Number : 2760006
-
Bendorf, Tyskland, 56170
- Investigational Site Number : 2760002
-
Berlin, Tyskland, 12159
- Investigational Site Number : 2760007
-
Frankfurt, Tyskland, 60596
- Investigational Site Number : 2760004
-
Frankfurt, Tyskland, 60596
- Investigational Site Number : 2760008
-
Frankfurt am Main, Tyskland, 60389
- Investigational Site Number : 2760003
-
Leipzig, Tyskland, 04347
- Investigational Site Number : 2760001
-
Mainz, Tyskland, 55128
- Investigational Site Number : 2760005
-
-
-
-
-
Debrecen, Ungarn, 4032
- Investigational Site Number : 3480006
-
Gödöllő, Ungarn, 2100
- Investigational Site Number : 3480002
-
Hajdúnánás, Ungarn, 4080
- Investigational Site Number : 3480003
-
Mosonmagyaróvár, Ungarn, 9200
- Investigational Site Number : 3480004
-
Pécs, Ungarn, 7635
- Investigational Site Number : 3480005
-
Püspökladány, Ungarn, 4150
- Investigational Site Number : 3480001
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Lunsekimig
Participants will receive lunsekimig (SC injection) every 4 weeks |
Pharmaceutical form: Solution for injection in vial; Route of administration: Subcutaneous injection
Andre navne:
Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration:Oral Inhalation Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation Pharmaceutical form: Aerosol for inhalation; Route of administration: Oral Inhalation |
|
Placebo komparator: Placebo
Participants will receive placebo (SC injection) every 4 weeks |
Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration:Oral Inhalation Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation Pharmaceutical form: Aerosol for inhalation; Route of administration: Oral Inhalation Pharmaceutical form: Solution for injection in vial; Route of administration: Subcutaneous injection |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Annualized rate of asthma exacerbation events
Tidsramme: From baseline up to 52 weeks
|
Asthma exacerbation event defined as: worsening of asthma requiring the use of systemic corticosteroids for ≥3 days; or hospitalization or emergency room visit due to asthma and requiring the use of systemic corticosteroids or death due to asthma |
From baseline up to 52 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Ændring fra baseline i præbronkodilatator (BD) forceret ekspiratorisk volumen på 1 sekund (FEV1)
Tidsramme: Fra baseline til uge 52
|
Fra baseline til uge 52
|
|
|
Ændring fra baseline i FeNO-niveau
Tidsramme: Fra baseline til uge 52
|
Fra baseline til uge 52
|
|
|
Årlig frekvens af astmaeksacerbationer, der kræver hospitalsindlæggelse eller skadestue eller akut besøg
Tidsramme: Fra baseline til uge 52
|
Fra baseline til uge 52
|
|
|
Total systemisk kortikosteroiddosis eksponering
Tidsramme: Fra baseline til uge 52
|
Fra baseline til uge 52
|
|
|
Ændring fra baseline i Astma Quality of Life Questionnaire Standardized (AQLQ{S}) score
Tidsramme: Fra baseline til uge 52
|
Fra baseline til uge 52
|
|
|
Ændring fra baseline i Asthma Daytime Symptom Diary (ADSD) daglige morgen- og aftenscore
Tidsramme: Fra baseline til uge 52
|
Fra baseline til uge 52
|
|
|
Serum lunsekimig koncentrationer
Tidsramme: Fra baseline til uge 56
|
Fra baseline til uge 56
|
|
|
Forekomst og titer af anti-lægemiddel-antistoffer (ADA) mod lunsekimig
Tidsramme: Fra baseline til uge 56
|
Fra baseline til uge 56
|
|
|
Forekomst af deltagere med behandlingsfremkaldte bivirkninger (TEAE'er), herunder lokale reaktioner, bivirkninger af særlig interesse (AESI'er), alvorlige bivirkninger (SAE'er)
Tidsramme: Fra baseline til uge 56
|
Fra baseline til uge 56
|
|
|
Change from baseline in Asthma Control Questionnaire5 (ACQ-5) score
Tidsramme: From baseline to week 52
|
The ACQ-5 is a questionnaire that measures the adequacy of asthma control and any changes in asthma control that may occur spontaneously or as a result of treatment. The ACQ-5 has five questions on the asthma symptoms and patients are asked to recall how their asthma has been during the previous week and to respond on a 7-point scale for each question (0 = no impairment, 6 = maximum impairment). The ACQ-5 score is the mean of the 5 questions and, therefore, between 0 (totally controlled) and 6 (severely uncontrolled). A high score indicates low asthma control. |
From baseline to week 52
|
|
Annualized rate of loss of asthma control events (LOAC) events
Tidsramme: From baseline to week 52
|
Annualized rate of LOAC events defined by 1 or more of the following criteria:
|
From baseline to week 52
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
7. november 2024
Primær færdiggørelse (Anslået)
21. juni 2027
Studieafslutning (Anslået)
19. juli 2027
Datoer for studieregistrering
Først indsendt
4. november 2024
Først indsendt, der opfyldte QC-kriterier
4. november 2024
Først opslået (Faktiske)
6. november 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i immunsystemet
- Luftvejssygdomme
- Lungesygdomme
- Bronchiale sygdomme
- Lungesygdomme, obstruktiv
- Respiratorisk overfølsomhed
- Overfølsomhed, Øjeblikkelig
- Overfølsomhed
- Astma
- Organiske kemikalier
- Farmaceutiske præparater
- Polycykliske forbindelser
- Aminer
- Graviditet
- Steroider
- SMUSED-RING-forbindelser
- Alkoholer
- Aminoalkoholer
- Androstadienes
- Androstenes
- Androstanes
- Ethanolaminer
- Phenethylaminer
- Ethylaminer
- Graviderede
- Gravidser
- Lægemiddelkombinationer
- Formoterol fumarat
- Salmeterol Xinafoate
- Fluticason
- Fluticason-salmeterol lægemiddelkombination
- Budesonid, formoterolfumarat lægemiddelkombination
- Albuterol
- Budesonid
Andre undersøgelses-id-numre
- ACT18301
- 2024-513959-33 (Registry Identifier: CTIS)
- U1111-1301-3938 (Registry Identifier: ICTRP)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .