Un estudio para evaluar la eficacia y seguridad de la terapia de inducción con RO7790121 en participantes con colitis ulcerosa activa de moderada a grave (Ametrine-2)
Un estudio de fase III, multicéntrico, doble ciego y controlado con placebo para evaluar la eficacia y seguridad de la terapia de inducción con RO7790121 en pacientes con colitis ulcerosa activa de moderada a grave
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).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Lüneburg, Alemania, 21339
- Medizinisches Zentrum Klinikum Lueneburg
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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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Linz, Austria, 4010
- Ordensklinikum Linz Barmherzige Schwestern
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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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Brussels, Bélgica, 1000
- CHU St Pierre (St Pierre)
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Brussels, Bélgica, 1200
- Cliniques Universitaires St-Luc
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Ontario
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Barrie, Ontario, Canadá, L4M 7G1
- Barrie GI Associates
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London, Ontario, Canadá, N6A 5A5
- London Health Sciences Centre Uni Campus
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London, Ontario, Canadá, N6K 1M6
- LDDI Clinical Trials Inc.
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Toronto, Ontario, Canadá, M6A 3B4
- TIDHI Innovation Inc.
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Quebec
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Montreal, Quebec, Canadá, H1T 2M4
- CIUSSS-de-l?Est-de-l?Île-de-Montréal
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Hradec Králové, Chequia, 500 12
- Hepato-Gastroenterologie HK, s.r.o.
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Prague, Chequia, 170 04
- ISCARE a.s.
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Santiago, Chile, 8330034
- Centro de Investigación Clínica UC-CICUC
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Osijek, Croacia, 31000
- Borzan Polyclinic
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Aalborg, Dinamarca, 9000
- Ålborg Universitets Hospital
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Zaragoza, España, 50009
- Hospital Universitario Miguel Servet
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Madrid
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Majadahonda, Madrid, España, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
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Alabama
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Dothan, Alabama, Estados Unidos, 36305
- Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan
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Arizona
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Scottsdale, Arizona, Estados Unidos, 85259
- Mayo Clinic Hospital
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Sun City, Arizona, Estados Unidos, 85351
- Arizona Digestive Health, P.C (ADH)
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California
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Apple Valley, California, Estados Unidos, 92307
- Om Research LLC
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Garden Grove, California, Estados Unidos, 92845
- Valley View Internal Medicine
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Lancaster, California, Estados Unidos, 93534
- Gastro Care Associates
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Redwood City, California, Estados Unidos, 94063
- Stanford Medicine Outpatient Center
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Colorado
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Colorado Springs, Colorado, Estados Unidos, 80907
- Peak Gastroenterology Associates
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Florida
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Coral Gables, Florida, Estados Unidos, 33134
- Hi Tech and Global Research, LLC
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Hialeah, Florida, Estados Unidos, 33013
- The Sister Life Research
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Miami, Florida, Estados Unidos, 33155
- Allied Biomedical Research Institute
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Miami, Florida, Estados Unidos, 33126
- LCC Medical Research Institute, LLC
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Orlando, Florida, Estados Unidos, 32825
- Digestive and Liver Center of Florida
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Orlando, Florida, Estados Unidos, 32807
- Integrity Trials LLC
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Port Orange, Florida, Estados Unidos, 32127
- Advanced Medical Research Center
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Tampa, Florida, Estados Unidos, 33612
- University of South Florida School of Medicine Morsani Center for Advanced Health Care
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Tampa, Florida, Estados Unidos, 33615
- Santos Research Center, CORP
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Tampa, Florida, Estados Unidos, 33614
- Guardian Angel Research Center, LLC
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Weston, Florida, Estados Unidos, 33331
- Cleveland Clinic Florida
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Georgia
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Atlanta, Georgia, Estados Unidos, 30342
- Atlanta Gastroenterology Associates
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Atlanta, Georgia, Estados Unidos, 30308
- Randomize Now, LLC
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Macon, Georgia, Estados Unidos, 31201
- Gastroenterology Associates of Central Georgia
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Illinois
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Glenview, Illinois, Estados Unidos, 60026
- Illinois Gastroenterology Group-Glenview powered by GI Alliance
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Gurnee, Illinois, Estados Unidos, 60031
- GI Alliance - Gurnee
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Indiana
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New Albany, Indiana, Estados Unidos, 47150
- Gastro Health Partners, LLC
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Kansas
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Wichita, Kansas, Estados Unidos, 67226
- Kansas Gastroenterology, LLC under Clinical Trials Network
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40218
- One GI: GHP - Gastroenterology Health Partners Louisville
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Louisiana
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Shreveport, Louisiana, Estados Unidos, 71105
- Louisiana Research Center - GastroIntestinal Associates
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Mississippi
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Flowood, Mississippi, Estados Unidos, 39232
- Allied Gastrointestinal Associates, PA
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756
- Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
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New York
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Brooklyn, New York, Estados Unidos, 11215
- Ellipsis Research Group
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New York, New York, Estados Unidos, 10021
- Weill Cornell Medical College
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New York, New York, Estados Unidos, 10016
- NYU Inflammatory Bowel Disease Center
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North Massapequa, New York, Estados Unidos, 11758
- DiGiovanna Inst for Med Ed&Res
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Queens Village, New York, Estados Unidos, 11428
- Queens Village Medical Care
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Rochester, New York, Estados Unidos, 14618
- Gastroenterology Group Of Rochester, LLP
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28207
- Charlotte Gastroenterology and Hepatology, P.L.L.C
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Fuquay-Varina, North Carolina, Estados Unidos, 27526
- Omega Research North Carolina, LLC
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High Point, North Carolina, Estados Unidos, 27260
- Peters Medical Research (PMR), LLC
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Ohio
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Beavercreek, Ohio, Estados Unidos, 45440
- Dayton Gastroenterology, Inc.
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Cincinnati, Ohio, Estados Unidos, 45267
- University of Cincinnati Hospital
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Foundation
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Columbus, Ohio, Estados Unidos, 43210
- Ohio State University
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Columbus, Ohio, Estados Unidos, 43202
- Ohio Gastroenterology Group
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Westlake, Ohio, Estados Unidos, 44145
- Gastro Intestinal Research Institute of Northern Ohio
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Pennsylvania
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Uniontown, Pennsylvania, Estados Unidos, 15401
- Frontier Clinical Re search, LLC
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02904
- University Gastroenterology
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South Carolina
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Greenville, South Carolina, Estados Unidos, 29607
- Gastroenterology Associates
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Tennessee
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Cordova, Tennessee, Estados Unidos, 38018
- Gastro One
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Texas
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Galveston, Texas, Estados Unidos, 77555
- Uni of Texas Medical Branch
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Garland, Texas, Estados Unidos, 75044
- GI Alliance
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Georgetown, Texas, Estados Unidos, 78628
- Amel Med LLC
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Harlingen, Texas, Estados Unidos, 78550
- Texas Digestive Specialists
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Harlingen, Texas, Estados Unidos, 78550
- Cano Medical Center
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Lubbock, Texas, Estados Unidos, 79410
- GI Alliance - Bay Area Gastroenterology
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Mansfield, Texas, Estados Unidos, 76063
- TDDC dba GI Alliance Research
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San Antonio, Texas, Estados Unidos, 78229
- Southern Star Research Institute, LLC.
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Temple, Texas, Estados Unidos, 76508
- Baylor Scott and White Medical Center
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Tyler, Texas, Estados Unidos, 75708
- University of Texas Health Center at Tyler
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Tyler, Texas, Estados Unidos, 75701
- Tyler Research Institute, LLC
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Webster, Texas, Estados Unidos, 77598
- TDDC GI Alliance research Webster
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Virginia
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Chesapeake, Virginia, Estados Unidos, 23320
- Gastroenterology Associates of Tidewater
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Lansdowne Town Center, Virginia, Estados Unidos, 20176
- Emeritas Research Group
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Roanoke, Virginia, Estados Unidos, 24018
- Gastroenterology Consultants of SWVA
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Chambray-lès-Tours, Francia, 37170
- CHU Tours - Hôpital Trousseau
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Clermont-Ferrand, Francia, 63000
- CHU Clermont Ferrand - Hôtel Dieu
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Créteil, Francia, 94000
- Hôpital Henri Mondor
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Nîmes, Francia, 30900
- Polyclinique Grand Sud
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Vandœuvre-lès-Nancy, Francia, 54511
- Hôpital de Brabois Adultes
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Budapest, Hungría, 1082
- Semmelweis Egyetem
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Debrecen, Hungría, 4025
- Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
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Szombathely, Hungría, 9700
- Vas-Oxy Egeszsegugyi Kft
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Székesfehérvár, Hungría, 8000
- Fejer Varmegyei Szent György Egyetemi Oktatokorhaz
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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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Veracruz, México, 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), México, 01120
- Boca Clinical Trials Mexico S.C. (Cd. Mexico)
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Tilburg, Países Bajos, 5022 GC
- ETZ Elisabeth
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?ód?, Polonia, 93-357
- Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi sp. z o.o.
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Bydgoszcz, Polonia, 85-231
- Medical Center Kermed
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Elblag, Polonia, 82-300
- Szpital Miejski sw. Jana Paw?a II w Elblagu
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I?awa, Polonia, 14-200
- Osrodek Badan Klinicznych Bd Research
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Knurów, Polonia, 44-190
- MZ Badania Slowik Zymla Sp.j.
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Krakow, Polonia, 31-513
- Centrum Medyczne Promed
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Lublin, Polonia, 20-582
- Medrise sp z o.o
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Poznan, Polonia, 61-731
- Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
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Późna, Polonia, 60-309
- EMC Instytut Medyczny SA
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Późna, Polonia, 61-441
- Gabinety Lekarskie Rivermed
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Sopot, Polonia, 81-756
- Endoskopia Sp. z o.o.
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Szczecin, Polonia, 71-685
- Sonomed Sp. z o.o.
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Warsaw, Polonia, 00-189
- Centrum Zdrowia-MDM
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Warsaw, Polonia, 02-679
- Medon Clinical Research sp. z o.o
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Warsaw, Polonia, 03-580
- Vivamed Spolka Z Ograniczona Odpowiedzialnoscia
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Wroc?aw, Polonia, 52-210
- PlanetMed sp. z o.o.
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Wroclaw, Polonia, 52-416
- Centrum Medyczne Oporow
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Changsha, Porcelana, 410013
- Third Xiangya Hospital Centrel South University
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Chengdu, Porcelana, 610041
- West China Hospital of Sichuan University
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Guangzhou, Porcelana, 510180
- Guangzhou First People's Hospital
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Guangzhou, Porcelana, 510260
- The second Affiliated Hospital of Guangzhou Medical University
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Hangzhou, Porcelana, 310016
- Sir Run Run Shaw Hospital Zhejiang University
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Huizhou, Porcelana, 516001
- Huizhou Central People's Hospital
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Nanning, Porcelana, 530021
- The First Affiliate Hospital of Guangxi Medical University
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Ningbo, Porcelana, 315000
- The First Affiliated Hospital of Ningbo University
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Qingdao, Porcelana, 266000
- The Affiliated Hospital of Medical College Qingdao University
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Shanghai, Porcelana, 200092
- Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
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Shanghai, Porcelana, 200025
- Ruijin Hospital Shanghai Jiaotong University School of Medicine
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Shenyang, Porcelana, 110004
- Shengjing Hospital of China Medical University
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Suzhou, Porcelana, 215006
- First Affiliated Hospital of Soochow University
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Xiamen, Porcelana, 361004
- Zhongshan Hospital Xiamen University
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100007
- Beijing No.6 Hospital
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Yunnan
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Kunming, Yunnan, Porcelana, 650032
- The First Affilliated Hospital of Kunming Medical University
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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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Leicester, Reino Unido, LE5 4PW
- Leicester General Hospital
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Llanrhystud, Reino Unido, SY23 1ER
- Bronglais General Hospital
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London, Reino Unido, SE5 9RS
- King College Hospital NHS Foundation Trust
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Stockport, Reino Unido, SK2 7JE
- Stepping Hill Hospital
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Zrenjanin, Serbia, 23000
- General Hospital "Djordje Joanovic"
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Chiang Mai, Tailandia, 50200
- Division of Gastroenterology, Depart of Internal Med., Fac of Med., Chiang Mai University
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Chon Buri, Tailandia, 20131
- Burapha University Hospital
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Ubonratchathani, Tailandia, 34000
- Sunpasitthiprasong Hospital
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Taichung, Taiwán, 40447
- China Medical University Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Afimkibart
Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection. |
Participants will receive afimkibart IV followed by afimkibart subcutaneous SC injection.
Otros nombres:
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Comparador de placebos: Placebo
Participants will receive placebo IV followed by placebo SC. |
Placebo matching IV afimkibart. Placebo matching SC afimkibart. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of Participants with Clinical Remission
Periodo de tiempo: At Week 12
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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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Partial Modified Mayo Score (pmMS)
Periodo de tiempo: 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
|
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Percentage of Participants with Endoscopic Improvement
Periodo de tiempo: 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
|
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Percentage of Participants with Endoscopic Remission
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Change in Abdominal Pain
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Clinical Trials, Hoffmann-La Roche
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- GA45330
- 2024-513015-27-00 (Ctis)
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
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
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .