En undersøgelse af Lebrikizumab hos deltagere med ukontrolleret astma, der er på inhalerede kortikosteroider og en anden kontrolmedicin
19. juni 2026 opdateret af: Hoffmann-La Roche
En fase III, randomiseret, dobbeltblind, placebokontrolleret undersøgelse for at vurdere effektiviteten og sikkerheden af Lebrikizumab hos patienter med ukontrolleret astma, der er på inhalerede kortikosteroider og en anden kontrolmedicin
Dette randomiserede, multicenter, dobbeltblindede, placebokontrollerede, parallelgruppestudie vil evaluere effektiviteten og sikkerheden af lebrikizumab hos deltagere med astma, hvis sygdom forbliver ukontrolleret på trods af daglig behandling med inhaleret kortikosteroidbehandling (ICS) og mindst én sekunds kontrolmedicin. .
Deltagerne vil blive randomiseret i forholdet 1:1:1 til at modtage dobbeltblind behandling med enten lebrikizumab ("høj" eller "lav") eller placebo, administreret subkutant (SC) hver 4. uge i 52 uger, ud over deres standard- plejeterapi.
Dette vil blive efterfulgt af en 52-ugers dobbeltblind aktiv behandlingsforlængelse.
Under den dobbeltblindede aktive behandlingsforlængelseperiode vil alle deltagere modtage SC-injektion af lebrikizumab fra uge 53 til uge 104.
Den forventede tid på studiebehandling er 104 uger.
Efter undersøgelsesbehandling vil alle deltagere gennemføre en 20-ugers sikkerhedsopfølgning.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1081
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Buenos Aires, Argentina, C1426ABP
- Centro Médico Dra de Salvo
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Buenos Aires, Argentina, C1122AAK
- Fundacion Faicep
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Mar del Plata, Argentina, B7602DCK
- Instituto Ave Pulmo
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Quilmes, Argentina, B1878FNR
- Centro Respiratorio Quilmes
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San Miguel de Tucumán, Argentina, T4000IAR
- Investigaciones en Patologias Respiratorias
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Victoria
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Box Hill, Victoria, Australien, 3128
- Box Hill Hospital; Eastern Clinical Research Unit
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Footscray, Victoria, Australien, 3011
- Footscray Hospital
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Western Australia
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Nedlands, Western Australia, Australien, 6009
- The Lung Institute of Western Australia; Sir Charles Gairdner Hospital
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Brussels, Belgien, 1200
- Cliniques Universitaires St-Luc
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Ghent, Belgien, 9000
- UZ Gent
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Ontario
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Toronto, Ontario, Canada, M5T 3A9
- Inspiration Research
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Toronto, Ontario, Canada, M9V4B4
- Albion Finch Medical Centre
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Quebec
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Trois-Rivières, Quebec, Canada, G8T 7A1
- C.I.C. Mauricie
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Santiago, Chile, 7500692
- Centro De Investigaciones Medicas Respiratorias
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Santiago, Chile, 7500698
- Schonffeldt y Guerrero Limitada
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Bogota DC, Colombia, 11001
- Fundacion Neumologica Colombiana
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Chertsey, Det Forenede Kongerige, KT16 0PZ
- St Peters Hospital
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Cottingham, Det Forenede Kongerige, HU16 5JQ
- Castle Hill Hospital; Respiratory Medicine
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Leeds, Det Forenede Kongerige, LS9 7TF
- St James University Hospital; Respiratory Department
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Alabama
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Pell City, Alabama, Forenede Stater, 35128
- Alabama Clinical Research Associates
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Arizona
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Tucson, Arizona, Forenede Stater, 85710
- Desert Sun Clinical Research LLC
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California
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Fountain Valley, California, Forenede Stater, 92708
- Allianz Medical and Research Center
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Long Beach, California, Forenede Stater, 90808
- Allergy & Asthma Medical Group & Research Center, Pc
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Los Angeles, California, Forenede Stater, 90025
- Allergy Medical Clinic
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Los Angeles, California, Forenede Stater, 90025
- CA Allergy & Asthma Med Grp
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Napa, California, Forenede Stater, 94558
- North Bay Clinical Trials
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Orange, California, Forenede Stater, 92868
- Choc Psf, Amc
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Rancho Mirage, California, Forenede Stater, 92270
- Advances in Medicine
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San Diego, California, Forenede Stater, 92108
- Allergy Assoc Medical Group
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Stockton, California, Forenede Stater, 95207
- Bensch Research Associates
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Colorado
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Centennial, Colorado, Forenede Stater, 80112
- IMMUNOe Research Centers
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Connecticut
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Waterbury, Connecticut, Forenede Stater, 06708
- Waterbury Pulmonary Associates
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Florida
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Clearwater, Florida, Forenede Stater, 33765
- St. Francis Sleep; Allergy & Lung Institute
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Miami, Florida, Forenede Stater, 33135
- Suncoast Research Group LLC
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Panama City, Florida, Forenede Stater, 32405
- Emerald Coast Research Associates
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Tallahassee, Florida, Forenede Stater, 32308
- Allergy & Asthma Diagnostic; Treatment Center
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Winter Park, Florida, Forenede Stater, 32789
- Florida Pulmonary Research Institute, LLC
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Georgia
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Woodstock, Georgia, Forenede Stater, 30188
- Atlanta Allergy & Asthma Clini
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Massachusetts
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North Dartmouth, Massachusetts, Forenede Stater, 02747
- Northeast Medical Research Associates, Inc
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Missouri
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St Louis, Missouri, Forenede Stater, 63141
- Midwest Clinical Research LLC
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Montana
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Missoula, Montana, Forenede Stater, 59808
- Montana Medical Research LLC
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68134
- Heartland Clinical Research Inc.
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Papillion, Nebraska, Forenede Stater, 68046
- Asthma & Allergy Center, P.C.
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89104
- Allergy & Asthma Associates
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New Jersey
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Mount Laurel, New Jersey, Forenede Stater, 08054
- Allergy & Asthma Research of Nj, Inc
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Ocean City, New Jersey, Forenede Stater, 07712
- Atlantic Research Center, LLC
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Skillman, New Jersey, Forenede Stater, 08558
- Princeton Center For Clinical Research
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New York
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The Bronx, New York, Forenede Stater, 10461
- Montefiore Medical Center
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North Carolina
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High Point, North Carolina, Forenede Stater, 27262
- Allergy & Asthma Center of NC
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Wilmington, North Carolina, Forenede Stater, 28401
- PMG Research of Wilmington
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Ohio
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Toledo, Ohio, Forenede Stater, 43617
- Asthma & Allergy Center
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73103
- Cor Clinical Research
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Oregon
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Eugene, Oregon, Forenede Stater, 97401-7721
- Allergy & Asthma Research Grp
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Medford, Oregon, Forenede Stater, 97504
- Clinical Research Inst. of Southern Oregon, Pc
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Portland, Oregon, Forenede Stater, 97202
- Allergy Associates Research Center LLC - CRN
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- Asthma Allergy Pulm Associates
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Sellersville, Pennsylvania, Forenede Stater, 18960
- Grand View Hospital; Clinical Research Department
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Rhode Island
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Lincoln, Rhode Island, Forenede Stater, 02865
- Asthma Allergy Phys of RI
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South Carolina
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Greenville, South Carolina, Forenede Stater, 29607
- ADAC Research PA
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Spartanburg, South Carolina, Forenede Stater, 29303
- Spartanburg Medical Research
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Texas
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Austin, Texas, Forenede Stater, 78745
- Tekton Research Inc
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Boerne, Texas, Forenede Stater, 78006
- TTS Research
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Dallas, Texas, Forenede Stater, 75231
- Pharmaceutical Research & Consulting, Inc.
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Houston, Texas, Forenede Stater, 077099
- Pioneer Research Solutions
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McKinney, Texas, Forenede Stater, 75069
- Metroplex Pulmonology & Sleep Center
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San Antonio, Texas, Forenede Stater, 78205
- Quality Assurance Research Ctr
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Virginia
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Fairfax, Virginia, Forenede Stater, 22030
- O & O Alpan, LLC
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Manassas, Virginia, Forenede Stater, 20110
- Manassas Clinical Research Center
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Richmond, Virginia, Forenede Stater, 23220
- Clinical Research Partners, LLC
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Washington
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Bellingham, Washington, Forenede Stater, 98225
- Bellingham Asthma, Allergy & Immunology
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Seattle, Washington, Forenede Stater, 98105
- ASTHMA, Inc
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Spokane, Washington, Forenede Stater, 99202
- Premier Clinical Research
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Lille, Frankrig, 59037
- Hopital Calmette; Pneumologie
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Montpellier, Frankrig, 34295
- Hopital Arnaud de Villeneuve
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Nantes, Frankrig, 44093
- CHU Nantes - Hôpital Laennec; Service de Pneumologie
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Strasbourg, Frankrig, 67091
- Nouvel Hopital Civil; Pole de Pathologie Thoracique
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Ashkelon, Israel, 78306
- Barzilai Medical Center; Pulmonary Inst.
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Haifa, Israel, 34362
- Lady Davis Carmel Medical Center; Cardiovascular Medicine
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Jerusalem, Israel, 9103102
- Shaare Zedek Medical Center
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Kfar Saba, Israel, 4428164
- Meir Medical Center; Pulmonary Dept
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Rehovot, Israel, 7610001
- Kaplan Medical Center
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Calabria
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Catanzaro, Calabria, Italien, 88100
- Azienda Ospedaliera Mater Domini Di Catanzaro
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Tuscany
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Pisa, Tuscany, Italien, 56124
- Università Degli Studi di Pisa - Ospedale di Cisanello Pisa
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Aichi, Japan, 489-8642
- Tosei General Hospital; Respiratory and Allergy Medicine
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Fukuoka, Japan, 815-8588
- Kyushu Central Hospital
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Higashiibaraki-gun, Japan, 311-3193
- National Hospital Organization Mito Medical Center
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Hokkaido, Japan, 070-8644
- National Hospital Organization Asahikawa Medical Center
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Hokkaido, Japan, 053-8506
- Oji General Hospital
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Kanagawa, Japan, 231-8682
- Yokohama City Minato Red Cross Hospital
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Kiyose-shi, Japan, 204-8585
- National Hospital Organization Tokyo National Hospital
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Kochi, Japan, 783-8505
- Kochi Medical School Hospital
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Kodaira-shi, Japan, 187-0024
- Oki Clinic
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Kokubunji-shi, Japan, 185-0014
- Takahashi Clinic
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Mizunami-shi, Japan, 509-6134
- Tono Chuo Clinic
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Nagaoka-shi, Japan, 940-2085
- Nagaoka Red Cross Hospital
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Niigata, Japan, 950-11977
- Niigata City General Hospital
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Numakunai, Japan, 028-3695
- Iwate Medical University Hospital
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Osaka, Japan, 545-8586
- Osaka Metropolitan university Hospital
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Sapporo, Japan, 062-8618
- Japan Community Health Care Organization Hokkaido Hospital
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Tokyo, Japan, 142-8666
- Showa University Hospital
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Tokyo, Japan, 103-0027
- Fukuwa Clinic
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Tokyo, Japan, 103-0028
- Tokyo Center Clinic; Internal Medicine
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Tokyo, Japan, 105-0003
- Sano Toranomon Clinic
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Toshima City, Japan, 171-0014
- Sekino Hospital
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Yoshida-gun, Japan, 910-1193
- University of Fukui Hospital
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Ōta-ku, Japan, 145-0063
- Senzoku Kokyuuki and Allergy Clinic
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Zapopan, Mexico, 45200
- Hospital Dr Angel Leaño universidad Autonoma de Guadalajara AC
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Jalisco
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Santa Cecilia, Jalisco, Mexico, 44700
- Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
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Auckland, New Zealand, 1051
- NZ Respiratory & Sleep Institute
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Dunedin, New Zealand
- Dunedin Hospital
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Dunedin, New Zealand
- RMC Medical Research Ltd
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Hastings, New Zealand, 4122
- P3 Research
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Bialystok, Polen, 15-003
- Centrum Medycyny Oddechowej Robert M. Mróz
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Krakow, Polen, 31-023
- Grazyna Pulka Specjalistyczny Osrodek ALL-MED
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Krakow, Polen, 31-637
- Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.
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Krakow, Polen, 30-349
- Specjalistyczne Centrum Medyczne NOWOMED
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Lódz, Polen, 90-153
- Poradnia Pulmonologiczna dla Doroslych
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Poznan, Polen, 60-214
- Centrum Alergologii Teresa Hofman
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Proszowice, Polen, 32-100
- SPZOZ Proszowice
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Skarżysko-Kamienna, Polen, 26-110
- Anna Bogusz Gabinet Alergologiczny
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Warsaw, Polen, 01-868
- Medica Pro Familia Sp. z o.o. S.K.A.
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Warsaw, Polen, 02-507
- Klinika Chorób Wewnetrznych i Alergologii MSW
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Wroclaw, Polen, 50-445
- ALL-MED Specjalistyczna Opieka Medyczna
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Bucharest, Rumænien, 020125
- Colentina Clinical Hospital
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Cluj-Napoca, Rumænien, 400162
- Prof.Dr.Octavian Fodor Emergency Clinical Hospital
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Craiova, Rumænien, 200515
- Spitalul Clinic de Boli Infecțioase si Pneumoftiziologie Victor Babes Craiova
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Timișoara, Rumænien, 300310
- Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital
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Kemerovo, Rusland, 650002
- SIH Kemerovo Regional Clinical Hospital
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Moscow, Rusland, 117292
- Russian Uni of People'S Friendship, Med. Faculty; City Clinical Hospital No 64, Internal Diseases
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Moscow, Rusland, 125367
- Central Clinical Hospital #1 of RZhD JCS
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Novosibirsk, Rusland, 630008
- Novosibirsk Municipal Clinical Hospital For Emergency Medicine #2
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Saint Petersburg, Rusland, 193231
- City Outpatient Dept #94
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Saint Petersburg, Rusland, 194354
- St-Petersburg Diagnostic Ctr#1; Pulmonology
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Saint Petersburg, Rusland, 197022
- St. Petersburg State Budget Medical Institution Pokrovskaya City Hospital
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Saint Petersburg, Rusland, 197022
- St.-Petersburg SMU n. a. Academician I.P.Pavlov; Therapy Department
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Smolensk, Rusland, 4812
- Smolensk State Medical Academy
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Tomsk, Rusland, 634063
- Tomsk Regional Clinical Hospital
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Ryazan Oblast
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Ryazan, Ryazan Oblast, Rusland, 390039
- Ryazan Regional Clinical Hosp
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Sankt-Peterburg
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Saint Petersburg, Sankt-Peterburg, Rusland, 194354
- LLC Medical Center Reavita Med SPb
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Saint Petersburg, Sankt-Peterburg, Rusland, 195271
- SHI Ctr Occupational Pathology
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Belgrade, Serbien, 11080
- Clinical Hospital Center ''Bezanijska Kosa''; Department of Pulmology
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Bardejov, Slovakiet, 085 01
- Alian s.r.o.
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Bratislava, Slovakiet, 831 03
- Tehelná Clinic, Inc; IMUNO-ALERGO, s. r.o.
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Spišská Nová Ves, Slovakiet, 052 01
- Plucna ambulancia
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Barcelona, Spanien, 08916
- Hospital Germans Trías i Pujol
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Barcelona, Spanien, 08025
- Hospital de la Santa Creu; i Sant Pau
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Madrid, Spanien, 28922
- Hosp Univ Fundacion Alcorcon
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Valencia, Spanien, 46017
- Hospital Universitario Doctor Peset
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Alava
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Vitoria-Gasteiz, Alava, Spanien, 01004
- Hospital Universitario Araba
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Cape Town, Sydafrika, 7925
- Uni of Cape Town Lung Inst.
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Cape Town, Sydafrika, 7764
- Melomed Hospital Gatesville
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Durban, Sydafrika, 4091
- Vawda Z.Fa Practice
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Gatesville, Sydafrika, 7746
- Gatesville Medical Centre
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Johannesburg, Sydafrika, 1820
- Deepak Lakha MBCHB Private Practice
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Seongnam-si, Sydkorea, 463-707
- Seoul National University Bundang Hospital
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Seoul, Sydkorea, 05505
- Asan Medical Center
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Seoul, Sydkorea, 06351
- Samsung Medical Center
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Seoul, Sydkorea, 08308
- Korea University Guro Hospital
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Seoul, Sydkorea, 130-709
- St. Paul's Hospital, The Catholic University of Korea, College of Medicine
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Jablonec nad Nisou, Tjekkiet, 466 01
- Alergopraktik s.r.o.
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Jindřichův Hradec, Tjekkiet, 377 38
- Interni A Pneumologicka Ambulance
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Ostrava - Poruba, Tjekkiet, 708 68
- MephaCentrum, a.s.
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Teplice, Tjekkiet, 415 01
- Alergologie Teplice, s.r.o.
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Ankara, Tyrkiet (Türkiye), 06290
- Atatürk Gö?üs Hastal?klar? ve Gö?üs Cerrahisi E?itim ve Ara?t?rma Hastanesi
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Bursa, Tyrkiet (Türkiye), 16059
- Uludag University; Pulmonology and Allergy Department
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Izmir, Tyrkiet (Türkiye), 35110
- Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
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Kirikkale, Tyrkiet (Türkiye), 71100
- Kirikkale Universitesi Tip Fakultesi Hastanesi
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Mersin, Tyrkiet (Türkiye), 33169
- Mersin University Medical Faculty
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Dnipro, Ukraine, 49000
- Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board
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Ivano-Frankivsk, Ukraine, 76018
- Regional Phthisiology and Pulmonology Center
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Kharkiv, Ukraine, 61002
- City Clinical Hospital #27
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Kyiv, Ukraine, 04107
- Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
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Kyiv, Ukraine, 03680
- Yanovskyy Inst of Phth. & Pulm; Clinical-functional
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Kyiv, Ukraine, 04201
- Kyiv City Clinical Hospital #8
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Kyiv, Ukraine, 02232
- Central Outpatient Hospital of Desnyansky District
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Lviv, Ukraine, 79010
- Danylo Halytskyy National Medical University; Lviv
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Vinnytsia, Ukraine, 21001
- Small Business Private Enterprise Medical Centre Pulse
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Zaporizhzhia, Ukraine, 69104
- Non-Commercial Enterprise City Clinical Hospital 1 of Zaporizhzhia City Council
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Debrecen, Ungarn, 4031
- Kenezy Korhaz Rendelointezet
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Győr, Ungarn, 9024
- Petz Aladar Megyei Oktato Korhaz
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Szeged, Ungarn, 6722
- C.C.C. Hospital Chest Diseases
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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 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Astmadiagnose i mere end lig med (>/=) 12 måneder før besøg 1
- Bronkodilatatorrespons ved besøg 1, 2 eller 3
- Præ-bronkodilatator FEV1 på 40 procent (%) - 80 % forudsagt ved både besøg 2 og 3
- På ICS-behandling med en samlet daglig dosis på 500-2000 mikrogram (mcg) fluticasonpropionat-tørpulverinhalator (DPI) eller tilsvarende i >/=6 måneder før besøg 1
- På en kvalificeret anden controller-medicin (langtidsvirkende beta-agonist [LABA], leukotrienreceptorantagonist [LTRA], langtidsvirkende muskarinantagonist [LAMA] eller theophyllin) i 6 måneder før besøg 1
- Ukontrolleret astma ved besøg 1 og/eller besøg 2 og ved besøg 3
- Røntgen af thorax eller computertomografi (CT) scanning inden for 3 måneder før besøg 1 eller røntgen af thorax under screeningsperioden (før besøg 3), der bekræfter fraværet af anden klinisk signifikant lungesygdom
- Demonstreret overholdelse af kontrolmedicin i screeningsperioden
Ekskluderingskriterier:
- Anamnese med alvorlig allergisk reaktion eller anafylaktisk reaktion på et biologisk middel eller kendt overfølsomhed over for en komponent af lebrikizumab-injektionen
- Vedligeholdelse af oral kortikosteroidbehandling inden for 3 måneder efter besøg 1
- Behandling med systemiske (orale, intravenøse [IV] eller intramuskulære [IM]) kortikosteroider inden for 4 uger før besøg 1 eller under screeningsperioden
- Behandling med intraartikulære kortikosteroider inden for 4 uger før besøg 1 eller i screeningsperioden eller forventet behov for intraartikulære kortikosteroider i løbet af undersøgelsen
- Infektion, der kræver hospitalsindlæggelse i >/= 24 timer eller kræver behandling med IV- eller im-antibiotika inden for 4 uger før besøg 1 eller under screening; Øvre eller nedre luftvejsinfektion inden for 4 uger før besøg 1 eller under screening; Aktiv infektion, der krævede behandling med orale antibiotika inden for 2 uger før besøg 1 eller under screening; Aktiv parasitinfektion eller Listeria monocytogenes-infektion inden for 6 måneder før besøg 1 eller under screening
- Aktiv tuberkulose, der kræver behandling inden for 12 måneder før besøg 1
- Kendt immundefekt, herunder, men ikke begrænset til, infektion med human immundefektvirus (HIV)
- Tegn på akut eller kronisk hepatitis eller kendt levercirrhose
- Anamnese med interstitiel lungesygdom, kronisk obstruktiv lungesygdom (KOL) eller anden klinisk signifikant lungesygdom bortset fra astma
- Kendt aktuel malignitet eller aktuel evaluering for potentiel malignitet
- Nuværende ryger eller tidligere ryger med en historie på mere end (>) 10 pakkeår
- Historie om alkohol- eller stofmisbrug
- Tidligere og/eller nuværende brug af enhver anti-interleukin (IL)-13- eller anti-IL-4/IL-13-behandling, inklusive lebrikizumab
- Brug af anden monoklonal antistofbehandling, inklusive omalizumab, inden for 6 måneder eller 5 lægemiddelhalveringstider før besøg 1 (alt efter hvad der er længst) eller under screening
- Påbegyndelse af eller ændring af allergen immunterapi inden for 3 måneder før besøg 1 eller under screening
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: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Lebrikizumab (37,5 mg)
Deltagerne vil modtage SC-injektion af lebrikizumab (37,5 mg) hver 4. uge i 104 uger.
|
Lebrikizumab vil blive administreret som subkutan injektion med 125 eller 37,5 mg hver 4. uge i 104 uger.
Andre navne:
Lebrikizumab matchende placebo vil blive administreret som subkutan injektion hver 4. uge i 52 uger.
|
|
Placebo komparator: Placebo
Deltagerne vil modtage SC-injektion af lebrikizumab-matchende placebo hver 4. uge i 52 uger i den placebokontrollerede periode og derefter SC-injektion af lebrikizumab med 125 eller 37,5 mg i 52 uger under den aktive forlængelsesperiode.
|
Lebrikizumab vil blive administreret som subkutan injektion med 125 eller 37,5 mg hver 4. uge i 104 uger.
Andre navne:
Lebrikizumab matchende placebo vil blive administreret som subkutan injektion hver 4. uge i 52 uger.
|
|
Eksperimentel: Lebrikizumab (125 mg)
Deltagerne vil modtage SC-injektion af lebrikizumab (125 milligram [mg]) hver 4. uge i 104 uger.
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Lebrikizumab vil blive administreret som subkutan injektion med 125 eller 37,5 mg hver 4. uge i 104 uger.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Adjusted Exacerbation Rate of Asthma During the 52-Week PCP
Tidsramme: Baseline up to 52 weeks
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Asthma exacerbation is defined as new or increased asthma symptoms (i.e., wheeze, cough, dyspnea, chest tightness, and/or night-time awakening due to these symptoms) that lead to systemic corticosteroid (CS) treatment (oral, intravenous (IV), or intramuscular (IM) CS for ≥ 3 days or an emergency department visit with at least one dose of IV or IM CS) or to hospitalization. Results are reported as a 'Number' representing the model-adjusted incidence rate of asthma exacerbations per person-year. To account for early discontinuation, for each patient, the time at risk (in years) was computed as the duration of this time period (last day minus first day [in days] plus 1) divided by 365.25. The 'first day' was the day of randomization to the PCP. For patients entering the ATE, the 'last day' was the day prior to ATE randomization. For patients not entering the ATE, the 'last day' was at the last study visit on/prior to Study Day 379 (365 days plus a 14-day window). |
Baseline up to 52 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 52
Tidsramme: Week 52
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FEV1 is the maximal amount of air, which can be forcefully exhaled in one second.
Measurements were performed before use of bronchodilator.
Reported is the absolute change from baseline in FEV1 to the end of the placebo-controlled period at Week 52.
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Week 52
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Time to First Asthma Exacerbation During the 52-week PCP
Tidsramme: Baseline up to 52 weeks
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An asthma exacerbation is defined as new or increased asthma symptoms (including wheeze, cough, dyspnea, chest tightness, and/or night-time awakening due to these symptoms) that lead to treatment with systemic corticosteroids or to hospitalisation.
Treatment with systemic corticosteroids is defined as treatment with oral, intravenous (IV), or intramuscular (IM) corticosteroids for at least 3 days or an emergency department visit with at least one dose of IV or IM corticosteroids.
Reported is the time to first asthma exacerbation during the 52-week placebo-controlled period.
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Baseline up to 52 weeks
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Rate of Urgent Asthma-Related Health Care Utilization (HCU) During the 52-week PCP
Tidsramme: Baseline up to Week 52
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Urgent health care utilization was defined as hospitalizations, emergency department visits, and acute care visits. Results are reported as a 'Number' representing the model-adjusted incidence rate of urgent asthma-related HCU events per person-year. To account for early discontinuation, for each patient, the time at risk (in years) was computed as the duration of this time period (last day minus first day [in days] plus 1) divided by 365.25. The 'first day' was the day of randomization to the PCP. For patients entering the ATE, the 'last day' was the day prior to ATE randomization. For patients not entering the ATE, the 'last day' was at the last study visit on/prior to Study Day 379 (365 days plus a 14-day window). |
Baseline up to Week 52
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Absolute Change From Baseline in Standardized AQLQ Score at Week 52
Tidsramme: Week 52
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Asthma-specific health-related quality of life was assessed by the overall score of the Standardized AQLQ.
The AQLQ is a self-administered test with 32 questions; each with seven possible answers ranging from 1 to 7 with a higher score being more favorable.
Total score is calculated as follows: sum of items 1to 32 divided by 32 for a score range of 1 to 7 with a higher score indicating a better outcome.
Reported is the change in AQLQ score from baseline to the end of the placebo-controlled period at Week 52.
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Week 52
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Absolute Change From Baseline In Asthma Rescue Medication Use at Week 52
Tidsramme: Week 52
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Reported here is the change in the number of puffs or nebulized treatments of asthma rescue medication from baseline to the end of the PCP at Week 52.
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Week 52
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Absolute Change From Baseline in ACQ-5 Score at Week 52
Tidsramme: Baseline, Week 52
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The ACQ-5 is test with 5 questions; each with seven possible answers ranging from 0 to 6 with a lower score being more favorable.
Total score range is 0 to 30 with a lower score indicating a better outcome.
Reported is the change in ACQ-5 score from baseline to the end of the PCP at Week 52.
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Baseline, Week 52
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Lebrikizumab
Tidsramme: Baseline up to Week 124 (assessed at Baseline, Weeks 4, 12, 24, 36, 52 and safety follow-up [20 weeks] or end of study)
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The safety population included all participants who received at least one dose of study medication.
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Baseline up to Week 124 (assessed at Baseline, Weeks 4, 12, 24, 36, 52 and safety follow-up [20 weeks] or end of study)
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Percentage of Participants With Adverse Events (AEs)
Tidsramme: Baseline up to Week 52 for Placebo arm. Week 53 to Week 104 for PBO/Lebrikizumab crossover arms. Baseline up to Week 104 for Lebrikizumab-only arms.
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An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment.
An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Preexisting conditions which worsen during a study are also considered as adverse events.
The safety population included all participants who received at least one dose of study medication.
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Baseline up to Week 52 for Placebo arm. Week 53 to Week 104 for PBO/Lebrikizumab crossover arms. Baseline up to Week 104 for Lebrikizumab-only arms.
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Minimum Serum Concentration (Cmin) of Lebrikizumab
Tidsramme: Predose (0 hour) at Weeks 4, 12, 24, 36, and 52
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Predose (0 hour) at Weeks 4, 12, 24, 36, and 52
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Clinical Trials, Hoffmann-La Roche
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.
Generelle publikationer
- Chen M, Shepard K 2nd, Yang M, Raut P, Pazwash H, Holweg CTJ, Choo E. Overlap of allergic, eosinophilic and type 2 inflammatory subtypes in moderate-to-severe asthma. Clin Exp Allergy. 2021 Apr;51(4):546-555. doi: 10.1111/cea.13790. Epub 2021 Jan 7.
- N Bauer R, Yang X, L Staton T, Olsson J, Holweg CTJ, R Arron J, Matthews JG, Choy DF. Seasonal variability of lung function and Asthma Quality of Life Questionnaire Scores in adults with uncontrolled asthma. BMJ Open Respir Res. 2019 Nov 11;6(1):e000406. doi: 10.1136/bmjresp-2019-000406. eCollection 2019.
- Hanania NA, Korenblat P, Chapman KR, Bateman ED, Kopecky P, Paggiaro P, Yokoyama A, Olsson J, Gray S, Holweg CT, Eisner M, Asare C, Fischer SK, Peng K, Putnam WS, Matthews JG. Efficacy and safety of lebrikizumab in patients with uncontrolled asthma (LAVOLTA I and LAVOLTA II): replicate, phase 3, randomised, double-blind, placebo-controlled trials. Lancet Respir Med. 2016 Oct;4(10):781-796. doi: 10.1016/S2213-2600(16)30265-X. Epub 2016 Sep 5.
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)
25. juli 2013
Primær færdiggørelse (Faktiske)
28. december 2016
Studieafslutning (Faktiske)
28. december 2016
Datoer for studieregistrering
Først indsendt
29. maj 2013
Først indsendt, der opfyldte QC-kriterier
29. maj 2013
Først opslået (Anslået)
3. juni 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GB28688
- 2013-000175-33 (EudraCT nummer)
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 .