En studie for å vurdere effektiviteten og sikkerheten til induksjonsterapi med RO7790121 hos deltakere med moderat til alvorlig aktiv ulcerøs kolitt (Ametrine-2)
En fase III, multisenter, dobbeltblind, placebokontrollert studie for å vurdere effektiviteten og sikkerheten til induksjonsterapi med RO7790121 hos pasienter med moderat til alvorlig aktiv ulcerøs kolitt
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Ciudad Autonoma Bs As, Argentina, C1280AEB
- Hospital Britanico
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Quilmes, Argentina, B1878DVB
- Instituto Medico CER
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New South Wales
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Macquarie Park, New South Wales, Australia, 2109
- Macquarie University Hospital
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Victoria
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Parkville, Victoria, Australia, 3050
- Royal Melbourne Hospital
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Brussels, Belgia, 1000
- CHU St Pierre (St Pierre)
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Brussels, Belgia, 1200
- Cliniques Universitaires St-Luc
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasil, 90035-000
- Hospital Moinhos de Vento
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Rio de Janeiro
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Volta Redonda, Rio de Janeiro, Brasil, 27258-000
- Instituto Lobus Unimed Volta Redonda
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Sergipe
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Aracaju, Sergipe, Brasil, 49055-000
- Newdata Clinical Trials
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São Paulo
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Jaú, São Paulo, Brasil, 17210-190
- CECIP - Centro de Estudos Clínicos do Interior Paulista
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São Paulo, São Paulo, Brasil, 04266-010
- Centro Paulista de Investigacao Clinica - CEPIC
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Plovdiv, Bulgaria, 4003
- MC " Sveti Ivan Rilski Chudotvorets- 2010
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Sofia, Bulgaria, 1407
- "City Clinic UMHAC" EOOD
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Ontario
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Barrie, Ontario, Canada, L4M 7G1
- Barrie GI Associates
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London, Ontario, Canada, N6A 5A5
- London Health Sciences Centre Uni Campus
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London, Ontario, Canada, N6K 1M6
- LDDI Clinical Trials Inc.
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Toronto, Ontario, Canada, M6A 3B4
- TIDHI Innovation Inc.
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Quebec
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Montreal, Quebec, Canada, H1T 2M4
- CIUSSS-de-l?Est-de-l?Île-de-Montréal
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Santiago, Chile, 8330034
- Centro de Investigación Clínica UC-CICUC
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Aalborg, Danmark, 9000
- Ålborg Universitets Hospital
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Alabama
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Dothan, Alabama, Forente stater, 36305
- Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan
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Arizona
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Scottsdale, Arizona, Forente stater, 85259
- Mayo Clinic Hospital
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Sun City, Arizona, Forente stater, 85351
- Arizona Digestive Health, P.C (ADH)
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California
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Apple Valley, California, Forente stater, 92307
- Om Research LLC
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Garden Grove, California, Forente stater, 92845
- Valley View Internal Medicine
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Lancaster, California, Forente stater, 93534
- Gastro Care Associates
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Redwood City, California, Forente stater, 94063
- Stanford Medicine Outpatient Center
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Colorado
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Colorado Springs, Colorado, Forente stater, 80907
- Peak Gastroenterology Associates
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Florida
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Coral Gables, Florida, Forente stater, 33134
- Hi Tech and Global Research, LLC
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Hialeah, Florida, Forente stater, 33013
- The Sister Life Research
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Miami, Florida, Forente stater, 33155
- Allied Biomedical Research Institute
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Miami, Florida, Forente stater, 33126
- LCC Medical Research Institute, LLC
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Orlando, Florida, Forente stater, 32825
- Digestive and Liver Center of Florida
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Orlando, Florida, Forente stater, 32807
- Integrity Trials LLC
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Port Orange, Florida, Forente stater, 32127
- Advanced Medical Research Center
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Tampa, Florida, Forente stater, 33612
- University of South Florida School of Medicine Morsani Center for Advanced Health Care
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Tampa, Florida, Forente stater, 33615
- Santos Research Center, CORP
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Tampa, Florida, Forente stater, 33614
- Guardian Angel Research Center, LLC
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Weston, Florida, Forente stater, 33331
- Cleveland Clinic Florida
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Georgia
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Atlanta, Georgia, Forente stater, 30342
- Atlanta Gastroenterology Associates
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Atlanta, Georgia, Forente stater, 30308
- Randomize Now, LLC
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Macon, Georgia, Forente stater, 31201
- Gastroenterology Associates of Central Georgia
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Illinois
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Glenview, Illinois, Forente stater, 60026
- Illinois Gastroenterology Group-Glenview powered by GI Alliance
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Gurnee, Illinois, Forente stater, 60031
- GI Alliance - Gurnee
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Indiana
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New Albany, Indiana, Forente stater, 47150
- Gastro Health Partners, LLC
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Kansas
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Wichita, Kansas, Forente stater, 67226
- Kansas Gastroenterology, LLC under Clinical Trials Network
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Kentucky
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Louisville, Kentucky, Forente stater, 40218
- One GI: GHP - Gastroenterology Health Partners Louisville
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Louisiana
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Shreveport, Louisiana, Forente stater, 71105
- Louisiana Research Center - GastroIntestinal Associates
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Mississippi
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Flowood, Mississippi, Forente stater, 39232
- Allied Gastrointestinal Associates, PA
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New Hampshire
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Lebanon, New Hampshire, Forente stater, 03756
- Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
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New York
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Brooklyn, New York, Forente stater, 11215
- Ellipsis Research Group
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New York, New York, Forente stater, 10021
- Weill Cornell Medical College
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New York, New York, Forente stater, 10016
- NYU Inflammatory Bowel Disease Center
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North Massapequa, New York, Forente stater, 11758
- DiGiovanna Inst for Med Ed&Res
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Queens Village, New York, Forente stater, 11428
- Queens Village Medical Care
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Rochester, New York, Forente stater, 14618
- Gastroenterology Group Of Rochester, LLP
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North Carolina
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Charlotte, North Carolina, Forente stater, 28207
- Charlotte Gastroenterology and Hepatology, P.L.L.C
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Fuquay-Varina, North Carolina, Forente stater, 27526
- Omega Research North Carolina, LLC
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High Point, North Carolina, Forente stater, 27260
- Peters Medical Research (PMR), LLC
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Ohio
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Beavercreek, Ohio, Forente stater, 45440
- Dayton Gastroenterology, Inc.
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Cincinnati, Ohio, Forente stater, 45267
- University of Cincinnati Hospital
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Cleveland, Ohio, Forente stater, 44195
- Cleveland Clinic Foundation
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Columbus, Ohio, Forente stater, 43210
- Ohio State University
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Columbus, Ohio, Forente stater, 43202
- Ohio Gastroenterology Group
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Westlake, Ohio, Forente stater, 44145
- Gastro Intestinal Research Institute of Northern Ohio
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Pennsylvania
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Uniontown, Pennsylvania, Forente stater, 15401
- Frontier Clinical Re search, LLC
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Rhode Island
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Providence, Rhode Island, Forente stater, 02904
- University Gastroenterology
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South Carolina
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Greenville, South Carolina, Forente stater, 29607
- Gastroenterology Associates
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Tennessee
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Cordova, Tennessee, Forente stater, 38018
- Gastro One
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Texas
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Galveston, Texas, Forente stater, 77555
- Uni of Texas Medical Branch
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Garland, Texas, Forente stater, 75044
- GI Alliance
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Georgetown, Texas, Forente stater, 78628
- Amel Med LLC
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Harlingen, Texas, Forente stater, 78550
- Texas Digestive Specialists
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Harlingen, Texas, Forente stater, 78550
- Cano Medical Center
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Lubbock, Texas, Forente stater, 79410
- GI Alliance - Bay Area Gastroenterology
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Mansfield, Texas, Forente stater, 76063
- TDDC dba GI Alliance Research
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San Antonio, Texas, Forente stater, 78229
- Southern Star Research Institute, LLC.
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Temple, Texas, Forente stater, 76508
- Baylor Scott and White Medical Center
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Tyler, Texas, Forente stater, 75708
- University of Texas Health Center at Tyler
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Tyler, Texas, Forente stater, 75701
- Tyler Research Institute, LLC
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Webster, Texas, Forente stater, 77598
- TDDC GI Alliance research Webster
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Virginia
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Chesapeake, Virginia, Forente stater, 23320
- Gastroenterology Associates of Tidewater
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Lansdowne Town Center, Virginia, Forente stater, 20176
- Emeritas Research Group
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Roanoke, Virginia, Forente stater, 24018
- Gastroenterology Consultants of SWVA
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Chambray-lès-Tours, Frankrike, 37170
- CHU Tours - Hôpital Trousseau
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Clermont-Ferrand, Frankrike, 63000
- CHU Clermont Ferrand - Hôtel Dieu
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Créteil, Frankrike, 94000
- Hôpital Henri Mondor
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Nîmes, Frankrike, 30900
- Polyclinique Grand Sud
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Vandœuvre-lès-Nancy, Frankrike, 54511
- Hôpital de Brabois Adultes
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Gujarat
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Surat, Gujarat, India, 395002
- Surat Institute of Digestive Sciences Hospitals
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Surat, Gujarat, India, 395009
- Gujarat Gastro and Vascular Hospital
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Maharashtra
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Nagpur (urban), Maharashtra, India, 440001
- Kingsway Hospital
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Nagpur (urban), Maharashtra, India, 440018
- MIDAS Multispeciality Hospital
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Rajasthan
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Jaipur, Rajasthan, India, 302006
- SR Kalla Memorial Gastro & General Hospital
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Jaipur, Rajasthan, India, 302007
- SMS Superspeciality Hospital
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Telangana
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Secunderabad, Telangana, India, 500003
- Yashoda Hospitals
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Beersheba, Israel, 8410101
- Soroka Medical Center
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Ramat Gan, Israel, 5265601
- The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's Hospital
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Lazio
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Rome, Lazio, Italia, 00128
- Policlinico Universitario Campus Biomedico Di Roma
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Rome, Lazio, Italia, 00186
- Ospedale Isola Tiberina Gemelli
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Lombardy
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Brescia, Lombardy, Italia, 25123
- Asst Degli Spedali Civili Di Brescia
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Milan, Lombardy, Italia, 20132
- IRCCS Ospedale San Raffaele
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Monza MI, Lombardy, Italia, 20900
- Azienda Ospedaliera San Gerardo di Monza
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Rozzano (MI), Lombardy, Italia, 20089
- Istituto Clinico Humanitas
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Veneto
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Negrar, Veneto, Italia, 37024
- IRCCS Ospedale Sacro Cuore Don Calabria
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Changsha, Kina, 410013
- Third Xiangya Hospital Centrel South University
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Chengdu, Kina, 610041
- West China Hospital of Sichuan University
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Guangzhou, Kina, 510180
- Guangzhou First People's Hospital
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Guangzhou, Kina, 510260
- The second Affiliated Hospital of Guangzhou Medical University
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Hangzhou, Kina, 310016
- Sir Run Run Shaw Hospital Zhejiang University
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Huizhou, Kina, 516001
- Huizhou Central People's Hospital
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Nanning, Kina, 530021
- The First Affiliate Hospital of Guangxi Medical University
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Ningbo, Kina, 315000
- The First Affiliated Hospital of Ningbo University
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Qingdao, Kina, 266000
- The Affiliated Hospital of Medical College Qingdao University
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Shanghai, Kina, 200092
- Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
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Shanghai, Kina, 200025
- Ruijin Hospital Shanghai Jiaotong University School of Medicine
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Shenyang, Kina, 110004
- Shengjing Hospital of China Medical University
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Suzhou, Kina, 215006
- First Affiliated Hospital of Soochow University
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Xiamen, Kina, 361004
- Zhongshan Hospital Xiamen University
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100007
- Beijing No.6 Hospital
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Yunnan
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Kunming, Yunnan, Kina, 650032
- The First Affilliated Hospital of Kunming Medical University
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Osijek, Kroatia, 31000
- Borzan Polyclinic
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Veracruz, Mexico, 91900
- FAICIC S de R.L. de C.V
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Mexico CITY (federal District)
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Miguel Hidalgo, Mexico CITY (federal District), Mexico, 01120
- Boca Clinical Trials Mexico S.C. (Cd. Mexico)
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Tilburg, Nederland, 5022 GC
- ETZ Elisabeth
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?ód?, Polen, 93-357
- Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi sp. z o.o.
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Bydgoszcz, Polen, 85-231
- Medical Center Kermed
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Elblag, Polen, 82-300
- Szpital Miejski sw. Jana Paw?a II w Elblagu
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I?awa, Polen, 14-200
- Osrodek Badan Klinicznych Bd Research
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Knurów, Polen, 44-190
- MZ Badania Slowik Zymla Sp.j.
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Krakow, Polen, 31-513
- Centrum Medyczne Promed
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Lublin, Polen, 20-582
- Medrise sp z o.o
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Poznan, Polen, 61-731
- Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
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Późna, Polen, 60-309
- EMC Instytut Medyczny SA
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Późna, Polen, 61-441
- Gabinety Lekarskie Rivermed
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Sopot, Polen, 81-756
- Endoskopia Sp. z o.o.
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Szczecin, Polen, 71-685
- Sonomed Sp. z o.o.
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Warsaw, Polen, 00-189
- Centrum Zdrowia-MDM
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Warsaw, Polen, 02-679
- Medon Clinical Research sp. z o.o
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Warsaw, Polen, 03-580
- Vivamed Spolka Z Ograniczona Odpowiedzialnoscia
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Wroc?aw, Polen, 52-210
- PlanetMed sp. z o.o.
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Wroclaw, Polen, 52-416
- Centrum Medyczne Oporow
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Braga, Portugal, 4710-243
- Hospital de Braga
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Lisbon, Portugal, 1500-650
- Hospital da Luz Lisboa
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Portimão, Portugal, 8500-338
- Centro Hospitalar do Algarve - Hospital de Portimao
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Porto, Portugal, 4202-451
- Hospital de Sao Joao
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Santa Maria da Feira, Portugal, 4520-211
- Centro Hospitalar de Entre Douro e Vouga - H. São Sebastião
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Viseu, Portugal, 3504-509
- Hospital Sao Teotonio
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San Juan, Puerto Rico, 00909
- Klinical Investigations Group LLC
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Zrenjanin, Serbia, 23000
- General Hospital "Djordje Joanovic"
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Zaragoza, Spania, 50009
- Hospital Universitario Miguel Servet
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Madrid
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Majadahonda, Madrid, Spania, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
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Leicester, Storbritannia, LE5 4PW
- Leicester General Hospital
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Llanrhystud, Storbritannia, SY23 1ER
- Bronglais General Hospital
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London, Storbritannia, SE5 9RS
- King College Hospital NHS Foundation Trust
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Stockport, Storbritannia, SK2 7JE
- Stepping Hill Hospital
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Taichung, Taiwan, 40447
- China Medical University Hospital
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Chiang Mai, Thailand, 50200
- Division of Gastroenterology, Depart of Internal Med., Fac of Med., Chiang Mai University
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Chon Buri, Thailand, 20131
- Burapha University Hospital
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Ubonratchathani, Thailand, 34000
- Sunpasitthiprasong Hospital
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Hradec Králové, Tsjekkia, 500 12
- Hepato-Gastroenterologie HK, s.r.o.
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Prague, Tsjekkia, 170 04
- ISCARE a.s.
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Lüneburg, Tyskland, 21339
- Medizinisches Zentrum Klinikum Lueneburg
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Budapest, Ungarn, 1082
- Semmelweis Egyetem
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Debrecen, Ungarn, 4025
- Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
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Szombathely, Ungarn, 9700
- Vas-Oxy Egeszsegugyi Kft
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Székesfehérvár, Ungarn, 8000
- Fejer Varmegyei Szent György Egyetemi Oktatokorhaz
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Linz, Østerrike, 4010
- Ordensklinikum Linz Barmherzige Schwestern
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Confirmed diagnosis of UC
- Moderately to severely active UC assessed by mMS
- Bodyweight >= 40 kilogram (kg)
- Up to date with colorectal cancer (CRC) screening performed according to local standards
- Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy
- Males and females of childbearing potential must meet protocol criteria for contraception requirements
Exclusion Criteria:
- Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)
- Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis
- Presence of an ostomy or ileoanal pouch
- Current diagnosis or suspicion of primary sclerosing cholangitis
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study
- Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed
- History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer
- Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
- Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
- Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Afimkibart
Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection. |
Participants will receive afimkibart IV followed by afimkibart subcutaneous SC injection.
Andre navn:
|
|
Placebo komparator: Placebo
Participants will receive placebo IV followed by placebo SC. |
Placebo matching IV afimkibart. Placebo matching SC afimkibart. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants with Clinical Remission
Tidsramme: At Week 12
|
Percentage of participants achieving Modified Mayo Score (mMS) <=2 with stool frequency subscore (SFS) = 0 or 1 (up to 1-2 stools more than normal), rectal bleeding subscore (RBS) = 0 (no blood seen) and endoscopic subscore (ES) = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. Each subscore is measured on a scale from 0 to 3, with higher values associated with greater severity. |
At Week 12
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Partial Modified Mayo Score (pmMS)
Tidsramme: From baseline to Week 2
|
Change in pmMS from baseline to Week 2. pmMS is a composite score of ulcerative colitis signs and symptoms activity given by the sum of the SFS and RBS. SFS is measured on a scale from 0 (normal number of stools) to 3 (5 or more stools than normal). RBS is measured on a scale from 0 (no blood seen) to 3 (blood alone passed). |
From baseline to Week 2
|
|
Percentage of Participants with Endoscopic Improvement
Tidsramme: At Week 12
|
Percentage of participants achieving endoscopic subscore of 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. |
At Week 12
|
|
Percentage of Participants with Endoscopic Remission
Tidsramme: At Week 12
|
Percentage of participants achieving endoscopic subscore of 0 (normal appearance of mucosa) at Week 12. |
At Week 12
|
|
Percentage of Participants with Clinical Response
Tidsramme: At Week 12
|
Percentage of participants achieving a decrease in mMS of at least 2 points and 30% from baseline and either a decrease in RBS >= 1 or RBS = 0 or 1 (no blood seen or stool with streaks of blood) at Week 12. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. SFS is measured on a scale from 0 (normal number of stools) to 3 (5 or more stools than normal). RBS is measured on a scale from 0 (no blood seen) to 3 (blood alone passed). ES is measured on a scale from 0 (normal appearance of mucosa) to 3 (severe disease). |
At Week 12
|
|
Percentage of Participants with Histologic Improvement
Tidsramme: At Week 12
|
Percentage of participants achieving a histologic improvement, defined as Geboes <=3.1 at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue). |
At Week 12
|
|
Percentage of Participants with Histologic Remission
Tidsramme: At Week 12
|
Percentage of participants achieving a histologic remission, defined as Geboes <2B at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue). |
At Week 12
|
|
Participants with Histologic-Endoscopic Mucosal Improvement
Tidsramme: At Week 12
|
Percentage of participants achieving Geboes <= 3.1 and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue). |
At Week 12
|
|
Percentage of Participants with Histologic-Endoscopic Remission
Tidsramme: At Week 12
|
Percentage of participants achieving Geboes < 2 and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue). |
At Week 12
|
|
Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants
Tidsramme: At Week 12
|
Percentage of participants achieving mMS <= 2 with SFS = 0 or 1 (up to 1-2 stools more than normal), RBS = 0 (no blood seen) and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12 in biomarker-defined subgroups. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. Each subscore is measured on a scale from 0 to 3, with higher values associated with greater severity. |
At Week 12
|
|
Percentage of Participants with Endoscopic Improvement: Among Biomarker-Defined Subgroups of Participants
Tidsramme: At Week 12
|
Percentage of participants achieving endoscopic subscore of 0 or 1 (normal appearance of mucosa or mild disease) at Week 12 in biomarker-defined subgroups. |
At Week 12
|
|
Change in Bowel Urgency
Tidsramme: Baseline through Week 12
|
Change in bowel urgency from baseline through Week 12. Bowel urgency is measured on a scale from 0 (None) to 4 (Severe). |
Baseline through Week 12
|
|
Change in Abdominal Pain
Tidsramme: Baseline through Week 12
|
Change in abdominal pain from baseline through Week 12. Abdominal pain is measured on a scale from 0 (None) to 4 (Severe). |
Baseline through Week 12
|
|
Change in Fatigue
Tidsramme: Baseline to Week 12
|
Change in fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) from baseline to Week 12. FACIT-Fatigue is a 13-item self-reported assessment of the level and impact of fatigue. The overall FACIT-Fatigue score ranges between 0 and 52, with higher scores associated with better quality of life concerns related to fatigue. |
Baseline to Week 12
|
|
Change in Health-Related Quality of Life
Tidsramme: Baseline to Week 12
|
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) score from baseline to Week 12. IBDQ is a 32-item self-reported assessment of health-related quality of life in participants with inflammatory bowel disease. The overall IBDQ score ranges from 32 to 224, with higher scores associated with better health-related quality of life. |
Baseline to Week 12
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Overall Change in UC Symptoms
Tidsramme: Baseline to Week 2 and Week 12
|
Patient Global Impression of Change (PGIC) from baseline to Weeks 2 and 12. PGIC measures overall change in ulcerative colitis symptoms from "Much better" to"Much worse". |
Baseline to Week 2 and Week 12
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Overall Severity in UC Symptoms
Tidsramme: Baseline to Week 2 and Week 12
|
Patient Global Impression of Severity (PGIS) from baseline to Weeks 2 and 12. PGIS measures severity of ulcerative colitis symptoms from "None" to "Very severe". |
Baseline to Week 2 and Week 12
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Incidence and Severity of Adverse Events (AEs)
Tidsramme: Up to 30 Weeks after Baseline
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Incidence and severity of AEs, including serious AEs, AEs leading to treatment discontinuation and AEs of special interest. |
Up to 30 Weeks after Baseline
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Clinical Trials, Hoffmann-La Roche
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- GA45330
- 2024-513015-27-00 (Ctis)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .