En undersøgelse for at vurdere effektiviteten og sikkerheden af induktionsterapi med RO7790121 hos deltagere med moderat til svær aktiv colitis ulcerosa (Ametrine-2)
Et fase III, multicenter, dobbeltblindt, placebokontrolleret studie for at vurdere effektiviteten og sikkerheden af induktionsterapi med RO7790121 hos patienter med moderat til svær aktiv colitis ulcerosa
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).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
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, Australien, 2109
- Macquarie University Hospital
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Victoria
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Parkville, Victoria, Australien, 3050
- Royal Melbourne Hospital
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Brussels, Belgien, 1000
- CHU St Pierre (St Pierre)
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Brussels, Belgien, 1200
- Cliniques Universitaires St-Luc
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasilien, 90035-000
- Hospital Moinhos de Vento
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Rio de Janeiro
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Volta Redonda, Rio de Janeiro, Brasilien, 27258-000
- Instituto Lobus Unimed Volta Redonda
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Sergipe
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Aracaju, Sergipe, Brasilien, 49055-000
- Newdata Clinical Trials
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São Paulo
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Jaú, São Paulo, Brasilien, 17210-190
- CECIP - Centro de Estudos Clínicos do Interior Paulista
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São Paulo, São Paulo, Brasilien, 04266-010
- Centro Paulista de Investigacao Clinica - CEPIC
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Plovdiv, Bulgarien, 4003
- MC " Sveti Ivan Rilski Chudotvorets- 2010
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Sofia, Bulgarien, 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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Leicester, Det Forenede Kongerige, LE5 4PW
- Leicester General Hospital
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Llanrhystud, Det Forenede Kongerige, SY23 1ER
- Bronglais General Hospital
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London, Det Forenede Kongerige, SE5 9RS
- King College Hospital NHS Foundation Trust
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Stockport, Det Forenede Kongerige, SK2 7JE
- Stepping Hill Hospital
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Alabama
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Dothan, Alabama, Forenede Stater, 36305
- Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan
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Arizona
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Scottsdale, Arizona, Forenede Stater, 85259
- Mayo Clinic Hospital
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Sun City, Arizona, Forenede Stater, 85351
- Arizona Digestive Health, P.C (ADH)
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California
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Apple Valley, California, Forenede Stater, 92307
- Om Research LLC
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Garden Grove, California, Forenede Stater, 92845
- Valley View Internal Medicine
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Lancaster, California, Forenede Stater, 93534
- Gastro Care Associates
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Redwood City, California, Forenede Stater, 94063
- Stanford Medicine Outpatient Center
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Colorado
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Colorado Springs, Colorado, Forenede Stater, 80907
- Peak Gastroenterology Associates
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Florida
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Coral Gables, Florida, Forenede Stater, 33134
- Hi Tech and Global Research, LLC
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Hialeah, Florida, Forenede Stater, 33013
- The Sister Life Research
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Miami, Florida, Forenede Stater, 33155
- Allied Biomedical Research Institute
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Miami, Florida, Forenede Stater, 33126
- LCC Medical Research Institute, LLC
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Orlando, Florida, Forenede Stater, 32825
- Digestive and Liver Center of Florida
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Orlando, Florida, Forenede Stater, 32807
- Integrity Trials LLC
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Port Orange, Florida, Forenede Stater, 32127
- Advanced Medical Research Center
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Tampa, Florida, Forenede Stater, 33612
- University of South Florida School of Medicine Morsani Center for Advanced Health Care
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Tampa, Florida, Forenede Stater, 33615
- Santos Research Center, CORP
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Tampa, Florida, Forenede Stater, 33614
- Guardian Angel Research Center, LLC
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Weston, Florida, Forenede Stater, 33331
- Cleveland Clinic Florida
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Georgia
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Atlanta, Georgia, Forenede Stater, 30342
- Atlanta Gastroenterology Associates
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Atlanta, Georgia, Forenede Stater, 30308
- Randomize Now, LLC
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Macon, Georgia, Forenede Stater, 31201
- Gastroenterology Associates of Central Georgia
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Illinois
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Glenview, Illinois, Forenede Stater, 60026
- Illinois Gastroenterology Group-Glenview powered by GI Alliance
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Gurnee, Illinois, Forenede Stater, 60031
- GI Alliance - Gurnee
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Indiana
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New Albany, Indiana, Forenede Stater, 47150
- Gastro Health Partners, LLC
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Kansas
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Wichita, Kansas, Forenede Stater, 67226
- Kansas Gastroenterology, LLC under Clinical Trials Network
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40218
- One GI: GHP - Gastroenterology Health Partners Louisville
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Louisiana
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Shreveport, Louisiana, Forenede Stater, 71105
- Louisiana Research Center - GastroIntestinal Associates
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Mississippi
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Flowood, Mississippi, Forenede Stater, 39232
- Allied Gastrointestinal Associates, PA
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756
- Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
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New York
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Brooklyn, New York, Forenede Stater, 11215
- Ellipsis Research Group
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New York, New York, Forenede Stater, 10021
- Weill Cornell Medical College
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New York, New York, Forenede Stater, 10016
- NYU Inflammatory Bowel Disease Center
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North Massapequa, New York, Forenede Stater, 11758
- DiGiovanna Inst for Med Ed&Res
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Queens Village, New York, Forenede Stater, 11428
- Queens Village Medical Care
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Rochester, New York, Forenede Stater, 14618
- Gastroenterology Group Of Rochester, LLP
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28207
- Charlotte Gastroenterology and Hepatology, P.L.L.C
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Fuquay-Varina, North Carolina, Forenede Stater, 27526
- Omega Research North Carolina, LLC
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High Point, North Carolina, Forenede Stater, 27260
- Peters Medical Research (PMR), LLC
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Ohio
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Beavercreek, Ohio, Forenede Stater, 45440
- Dayton Gastroenterology, Inc.
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Cincinnati, Ohio, Forenede Stater, 45267
- University of Cincinnati Hospital
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Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Foundation
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Columbus, Ohio, Forenede Stater, 43210
- Ohio State University
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Columbus, Ohio, Forenede Stater, 43202
- Ohio Gastroenterology Group
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Westlake, Ohio, Forenede Stater, 44145
- Gastro Intestinal Research Institute of Northern Ohio
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Pennsylvania
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Uniontown, Pennsylvania, Forenede Stater, 15401
- Frontier Clinical Re search, LLC
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02904
- University Gastroenterology
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South Carolina
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Greenville, South Carolina, Forenede Stater, 29607
- Gastroenterology Associates
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Tennessee
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Cordova, Tennessee, Forenede Stater, 38018
- Gastro One
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Texas
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Galveston, Texas, Forenede Stater, 77555
- Uni of Texas Medical Branch
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Garland, Texas, Forenede Stater, 75044
- GI Alliance
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Georgetown, Texas, Forenede Stater, 78628
- Amel Med LLC
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Harlingen, Texas, Forenede Stater, 78550
- Texas Digestive Specialists
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Harlingen, Texas, Forenede Stater, 78550
- Cano Medical Center
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Lubbock, Texas, Forenede Stater, 79410
- GI Alliance - Bay Area Gastroenterology
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Mansfield, Texas, Forenede Stater, 76063
- TDDC dba GI Alliance Research
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San Antonio, Texas, Forenede Stater, 78229
- Southern Star Research Institute, LLC.
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Temple, Texas, Forenede Stater, 76508
- Baylor Scott and White Medical Center
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Tyler, Texas, Forenede Stater, 75708
- University of Texas Health Center at Tyler
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Tyler, Texas, Forenede Stater, 75701
- Tyler Research Institute, LLC
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Webster, Texas, Forenede Stater, 77598
- TDDC GI Alliance research Webster
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Virginia
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Chesapeake, Virginia, Forenede Stater, 23320
- Gastroenterology Associates of Tidewater
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Lansdowne Town Center, Virginia, Forenede Stater, 20176
- Emeritas Research Group
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Roanoke, Virginia, Forenede Stater, 24018
- Gastroenterology Consultants of SWVA
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Chambray-lès-Tours, Frankrig, 37170
- CHU Tours - Hôpital Trousseau
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Clermont-Ferrand, Frankrig, 63000
- CHU Clermont Ferrand - Hôtel Dieu
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Créteil, Frankrig, 94000
- Hôpital Henri Mondor
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Nîmes, Frankrig, 30900
- Polyclinique Grand Sud
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Vandœuvre-lès-Nancy, Frankrig, 54511
- Hôpital de Brabois Adultes
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Tilburg, Holland, 5022 GC
- ETZ Elisabeth
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Gujarat
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Surat, Gujarat, Indien, 395002
- Surat Institute of Digestive Sciences Hospitals
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Surat, Gujarat, Indien, 395009
- Gujarat Gastro and Vascular Hospital
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Maharashtra
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Nagpur (urban), Maharashtra, Indien, 440001
- Kingsway Hospital
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Nagpur (urban), Maharashtra, Indien, 440018
- MIDAS Multispeciality Hospital
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Rajasthan
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Jaipur, Rajasthan, Indien, 302006
- SR Kalla Memorial Gastro & General Hospital
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Jaipur, Rajasthan, Indien, 302007
- SMS Superspeciality Hospital
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Telangana
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Secunderabad, Telangana, Indien, 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, Italien, 00128
- Policlinico Universitario Campus Biomedico Di Roma
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Rome, Lazio, Italien, 00186
- Ospedale Isola Tiberina Gemelli
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Lombardy
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Brescia, Lombardy, Italien, 25123
- Asst Degli Spedali Civili Di Brescia
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Milan, Lombardy, Italien, 20132
- IRCCS Ospedale San Raffaele
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Monza MI, Lombardy, Italien, 20900
- Azienda Ospedaliera San Gerardo di Monza
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Rozzano (MI), Lombardy, Italien, 20089
- Istituto Clinico Humanitas
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Veneto
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Negrar, Veneto, Italien, 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, Kroatien, 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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?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, Serbien, 23000
- General Hospital "Djordje Joanovic"
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Zaragoza, Spanien, 50009
- Hospital Universitario Miguel Servet
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Madrid
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Majadahonda, Madrid, Spanien, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
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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, Tjekkiet, 500 12
- Hepato-Gastroenterologie HK, s.r.o.
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Prague, Tjekkiet, 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, Østrig, 4010
- Ordensklinikum Linz Barmherzige Schwestern
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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 navne:
|
|
Placebo komparator: Placebo
Participants will receive placebo IV followed by placebo SC. |
Placebo matching IV afimkibart. Placebo matching SC afimkibart. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
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Change in Health-Related Quality of Life
Tidsramme: Baseline to Week 12
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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
|
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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Clinical Trials, Hoffmann-La Roche
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- GA45330
- 2024-513015-27-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (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
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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