Badanie oceniające skuteczność i bezpieczeństwo terapii indukcyjnej za pomocą RO7790121 u uczestników z umiarkowaną do ciężkiej czynną wrzodziejącą zapaleniem jelita grubego (Ametrine-2)
Wieloośrodkowe badanie III fazy, prowadzone metodą podwójnie ślepej próby, kontrolowane placebo, mające na celu ocenę skuteczności i bezpieczeństwa terapii indukcyjnej lekiem RO7790121 u pacjentów z umiarkowaną do ciężkiej czynną postacią wrzodziejącego zapalenia jelita grubego
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).
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Faza 3
Kontakty i lokalizacje
Lokalizacje studiów
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Ciudad Autonoma Bs As, Argentyna, C1280AEB
- Hospital Britanico
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Quilmes, Argentyna, 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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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, Brazylia, 90035-000
- Hospital Moinhos de Vento
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Rio de Janeiro
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Volta Redonda, Rio de Janeiro, Brazylia, 27258-000
- Instituto Lobus Unimed Volta Redonda
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Sergipe
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Aracaju, Sergipe, Brazylia, 49055-000
- Newdata Clinical Trials
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São Paulo
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Jaú, São Paulo, Brazylia, 17210-190
- CECIP - Centro de Estudos Clínicos do Interior Paulista
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São Paulo, São Paulo, Brazylia, 04266-010
- Centro Paulista de Investigacao Clinica - CEPIC
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Plovdiv, Bułgaria, 4003
- MC " Sveti Ivan Rilski Chudotvorets- 2010
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Sofia, Bułgaria, 1407
- "City Clinic UMHAC" EOOD
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Santiago, Chile, 8330034
- Centro de Investigación Clínica UC-CICUC
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Changsha, Chiny, 410013
- Third Xiangya Hospital Centrel South University
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Chengdu, Chiny, 610041
- West China Hospital of Sichuan University
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Guangzhou, Chiny, 510180
- Guangzhou First People's Hospital
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Guangzhou, Chiny, 510260
- The second Affiliated Hospital of Guangzhou Medical University
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Hangzhou, Chiny, 310016
- Sir Run Run Shaw Hospital Zhejiang University
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Huizhou, Chiny, 516001
- Huizhou Central People's Hospital
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Nanning, Chiny, 530021
- The First Affiliate Hospital of Guangxi Medical University
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Ningbo, Chiny, 315000
- The First Affiliated Hospital of Ningbo University
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Qingdao, Chiny, 266000
- The Affiliated Hospital of Medical College Qingdao University
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Shanghai, Chiny, 200092
- Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
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Shanghai, Chiny, 200025
- Ruijin Hospital Shanghai Jiaotong University School of Medicine
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Shenyang, Chiny, 110004
- Shengjing Hospital of China Medical University
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Suzhou, Chiny, 215006
- First Affiliated Hospital of Soochow University
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Xiamen, Chiny, 361004
- Zhongshan Hospital Xiamen University
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Beijing Municipality
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Beijing, Beijing Municipality, Chiny, 100007
- Beijing No.6 Hospital
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Yunnan
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Kunming, Yunnan, Chiny, 650032
- The First Affilliated Hospital of Kunming Medical University
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Osijek, Chorwacja, 31000
- Borzan Polyclinic
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Hradec Králové, Czechy, 500 12
- Hepato-Gastroenterologie HK, s.r.o.
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Prague, Czechy, 170 04
- ISCARE a.s.
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Aalborg, Dania, 9000
- Ålborg Universitets Hospital
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Chambray-lès-Tours, Francja, 37170
- CHU Tours - Hôpital Trousseau
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Clermont-Ferrand, Francja, 63000
- CHU Clermont Ferrand - Hôtel Dieu
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Créteil, Francja, 94000
- Hôpital Henri Mondor
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Nîmes, Francja, 30900
- Polyclinique Grand Sud
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Vandœuvre-lès-Nancy, Francja, 54511
- Hôpital de Brabois Adultes
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Zaragoza, Hiszpania, 50009
- Hospital Universitario Miguel Servet
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Madrid
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Majadahonda, Madrid, Hiszpania, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
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Tilburg, Holandia, 5022 GC
- ETZ Elisabeth
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Gujarat
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Surat, Gujarat, Indie, 395002
- Surat Institute of Digestive Sciences Hospitals
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Surat, Gujarat, Indie, 395009
- Gujarat Gastro and Vascular Hospital
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Maharashtra
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Nagpur (urban), Maharashtra, Indie, 440001
- Kingsway Hospital
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Nagpur (urban), Maharashtra, Indie, 440018
- MIDAS Multispeciality Hospital
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Rajasthan
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Jaipur, Rajasthan, Indie, 302006
- SR Kalla Memorial Gastro & General Hospital
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Jaipur, Rajasthan, Indie, 302007
- SMS Superspeciality Hospital
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Telangana
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Secunderabad, Telangana, Indie, 500003
- Yashoda Hospitals
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Beersheba, Izrael, 8410101
- Soroka Medical Center
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Ramat Gan, Izrael, 5265601
- The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's Hospital
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Ontario
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Barrie, Ontario, Kanada, L4M 7G1
- Barrie GI Associates
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London, Ontario, Kanada, N6A 5A5
- London Health Sciences Centre Uni Campus
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London, Ontario, Kanada, N6K 1M6
- LDDI Clinical Trials Inc.
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Toronto, Ontario, Kanada, M6A 3B4
- TIDHI Innovation Inc.
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Quebec
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Montreal, Quebec, Kanada, H1T 2M4
- CIUSSS-de-l?Est-de-l?Île-de-Montréal
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Veracruz, Meksyk, 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), Meksyk, 01120
- Boca Clinical Trials Mexico S.C. (Cd. Mexico)
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Lüneburg, Niemcy, 21339
- Medizinisches Zentrum Klinikum Lueneburg
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?ód?, Polska, 93-357
- Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi sp. z o.o.
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Bydgoszcz, Polska, 85-231
- Medical Center Kermed
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Elblag, Polska, 82-300
- Szpital Miejski sw. Jana Paw?a II w Elblagu
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I?awa, Polska, 14-200
- Osrodek Badan Klinicznych Bd Research
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Knurów, Polska, 44-190
- MZ Badania Slowik Zymla Sp.j.
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Krakow, Polska, 31-513
- Centrum Medyczne Promed
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Lublin, Polska, 20-582
- Medrise sp z o.o
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Poznan, Polska, 61-731
- Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
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Późna, Polska, 60-309
- EMC Instytut Medyczny SA
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Późna, Polska, 61-441
- Gabinety Lekarskie Rivermed
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Sopot, Polska, 81-756
- Endoskopia Sp. z o.o.
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Szczecin, Polska, 71-685
- Sonomed Sp. z o.o.
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Warsaw, Polska, 00-189
- Centrum Zdrowia-MDM
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Warsaw, Polska, 02-679
- Medon Clinical Research sp. z o.o
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Warsaw, Polska, 03-580
- Vivamed Spolka Z Ograniczona Odpowiedzialnoscia
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Wroc?aw, Polska, 52-210
- PlanetMed sp. z o.o.
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Wroclaw, Polska, 52-416
- Centrum Medyczne Oporow
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San Juan, Portoryko, 00909
- Klinical Investigations Group LLC
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Braga, Portugalia, 4710-243
- Hospital de Braga
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Lisbon, Portugalia, 1500-650
- Hospital da Luz Lisboa
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Portimão, Portugalia, 8500-338
- Centro Hospitalar do Algarve - Hospital de Portimao
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Porto, Portugalia, 4202-451
- Hospital de Sao Joao
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Santa Maria da Feira, Portugalia, 4520-211
- Centro Hospitalar de Entre Douro e Vouga - H. São Sebastião
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Viseu, Portugalia, 3504-509
- Hospital Sao Teotonio
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Zrenjanin, Serbia, 23000
- General Hospital "Djordje Joanovic"
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Alabama
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Dothan, Alabama, Stany Zjednoczone, 36305
- Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan
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Arizona
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Scottsdale, Arizona, Stany Zjednoczone, 85259
- Mayo Clinic Hospital
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Sun City, Arizona, Stany Zjednoczone, 85351
- Arizona Digestive Health, P.C (ADH)
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California
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Apple Valley, California, Stany Zjednoczone, 92307
- Om Research LLC
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Garden Grove, California, Stany Zjednoczone, 92845
- Valley View Internal Medicine
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Lancaster, California, Stany Zjednoczone, 93534
- Gastro Care Associates
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Redwood City, California, Stany Zjednoczone, 94063
- Stanford Medicine Outpatient Center
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Colorado
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Colorado Springs, Colorado, Stany Zjednoczone, 80907
- Peak Gastroenterology Associates
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Florida
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Coral Gables, Florida, Stany Zjednoczone, 33134
- Hi Tech and Global Research, LLC
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Hialeah, Florida, Stany Zjednoczone, 33013
- The Sister Life Research
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Miami, Florida, Stany Zjednoczone, 33155
- Allied Biomedical Research Institute
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Miami, Florida, Stany Zjednoczone, 33126
- LCC Medical Research Institute, LLC
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Orlando, Florida, Stany Zjednoczone, 32825
- Digestive and Liver Center of Florida
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Orlando, Florida, Stany Zjednoczone, 32807
- Integrity Trials LLC
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Port Orange, Florida, Stany Zjednoczone, 32127
- Advanced Medical Research Center
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Tampa, Florida, Stany Zjednoczone, 33612
- University of South Florida School of Medicine Morsani Center for Advanced Health Care
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Tampa, Florida, Stany Zjednoczone, 33615
- Santos Research Center, CORP
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Tampa, Florida, Stany Zjednoczone, 33614
- Guardian Angel Research Center, LLC
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Weston, Florida, Stany Zjednoczone, 33331
- Cleveland Clinic Florida
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Georgia
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Atlanta, Georgia, Stany Zjednoczone, 30342
- Atlanta Gastroenterology Associates
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Atlanta, Georgia, Stany Zjednoczone, 30308
- Randomize Now, LLC
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Macon, Georgia, Stany Zjednoczone, 31201
- Gastroenterology Associates of Central Georgia
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Illinois
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Glenview, Illinois, Stany Zjednoczone, 60026
- Illinois Gastroenterology Group-Glenview powered by GI Alliance
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Gurnee, Illinois, Stany Zjednoczone, 60031
- GI Alliance - Gurnee
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Indiana
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New Albany, Indiana, Stany Zjednoczone, 47150
- Gastro Health Partners, LLC
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Kansas
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Wichita, Kansas, Stany Zjednoczone, 67226
- Kansas Gastroenterology, LLC under Clinical Trials Network
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Kentucky
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Louisville, Kentucky, Stany Zjednoczone, 40218
- One GI: GHP - Gastroenterology Health Partners Louisville
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Louisiana
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Shreveport, Louisiana, Stany Zjednoczone, 71105
- Louisiana Research Center - GastroIntestinal Associates
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Mississippi
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Flowood, Mississippi, Stany Zjednoczone, 39232
- Allied Gastrointestinal Associates, PA
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New Hampshire
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Lebanon, New Hampshire, Stany Zjednoczone, 03756
- Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
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New York
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Brooklyn, New York, Stany Zjednoczone, 11215
- Ellipsis Research Group
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New York, New York, Stany Zjednoczone, 10021
- Weill Cornell Medical College
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New York, New York, Stany Zjednoczone, 10016
- NYU Inflammatory Bowel Disease Center
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North Massapequa, New York, Stany Zjednoczone, 11758
- DiGiovanna Inst for Med Ed&Res
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Queens Village, New York, Stany Zjednoczone, 11428
- Queens Village Medical Care
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Rochester, New York, Stany Zjednoczone, 14618
- Gastroenterology Group Of Rochester, LLP
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North Carolina
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Charlotte, North Carolina, Stany Zjednoczone, 28207
- Charlotte Gastroenterology and Hepatology, P.L.L.C
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Fuquay-Varina, North Carolina, Stany Zjednoczone, 27526
- Omega Research North Carolina, LLC
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High Point, North Carolina, Stany Zjednoczone, 27260
- Peters Medical Research (PMR), LLC
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Ohio
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Beavercreek, Ohio, Stany Zjednoczone, 45440
- Dayton Gastroenterology, Inc.
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Cincinnati, Ohio, Stany Zjednoczone, 45267
- University of Cincinnati Hospital
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Cleveland, Ohio, Stany Zjednoczone, 44195
- Cleveland Clinic Foundation
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Columbus, Ohio, Stany Zjednoczone, 43210
- Ohio State University
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Columbus, Ohio, Stany Zjednoczone, 43202
- Ohio Gastroenterology Group
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Westlake, Ohio, Stany Zjednoczone, 44145
- Gastro Intestinal Research Institute of Northern Ohio
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Pennsylvania
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Uniontown, Pennsylvania, Stany Zjednoczone, 15401
- Frontier Clinical Re search, LLC
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Rhode Island
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Providence, Rhode Island, Stany Zjednoczone, 02904
- University Gastroenterology
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South Carolina
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Greenville, South Carolina, Stany Zjednoczone, 29607
- Gastroenterology Associates
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Tennessee
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Cordova, Tennessee, Stany Zjednoczone, 38018
- Gastro One
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Texas
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Galveston, Texas, Stany Zjednoczone, 77555
- Uni of Texas Medical Branch
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Garland, Texas, Stany Zjednoczone, 75044
- GI Alliance
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Georgetown, Texas, Stany Zjednoczone, 78628
- Amel Med LLC
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Harlingen, Texas, Stany Zjednoczone, 78550
- Texas Digestive Specialists
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Harlingen, Texas, Stany Zjednoczone, 78550
- Cano Medical Center
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Lubbock, Texas, Stany Zjednoczone, 79410
- GI Alliance - Bay Area Gastroenterology
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Mansfield, Texas, Stany Zjednoczone, 76063
- TDDC dba GI Alliance Research
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San Antonio, Texas, Stany Zjednoczone, 78229
- Southern Star Research Institute, LLC.
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Temple, Texas, Stany Zjednoczone, 76508
- Baylor Scott and White Medical Center
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Tyler, Texas, Stany Zjednoczone, 75708
- University of Texas Health Center at Tyler
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Tyler, Texas, Stany Zjednoczone, 75701
- Tyler Research Institute, LLC
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Webster, Texas, Stany Zjednoczone, 77598
- TDDC GI Alliance research Webster
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Virginia
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Chesapeake, Virginia, Stany Zjednoczone, 23320
- Gastroenterology Associates of Tidewater
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Lansdowne Town Center, Virginia, Stany Zjednoczone, 20176
- Emeritas Research Group
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Roanoke, Virginia, Stany Zjednoczone, 24018
- Gastroenterology Consultants of SWVA
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Chiang Mai, Tajlandia, 50200
- Division of Gastroenterology, Depart of Internal Med., Fac of Med., Chiang Mai University
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Chon Buri, Tajlandia, 20131
- Burapha University Hospital
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Ubonratchathani, Tajlandia, 34000
- Sunpasitthiprasong Hospital
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Taichung, Tajwan, 40447
- China Medical University Hospital
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Budapest, Węgry, 1082
- Semmelweis Egyetem
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Debrecen, Węgry, 4025
- Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
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Szombathely, Węgry, 9700
- Vas-Oxy Egeszsegugyi Kft
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Székesfehérvár, Węgry, 8000
- Fejer Varmegyei Szent György Egyetemi Oktatokorhaz
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Lazio
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Rome, Lazio, Włochy, 00128
- Policlinico Universitario Campus Biomedico Di Roma
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Rome, Lazio, Włochy, 00186
- Ospedale Isola Tiberina Gemelli
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Lombardy
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Brescia, Lombardy, Włochy, 25123
- Asst Degli Spedali Civili Di Brescia
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Milan, Lombardy, Włochy, 20132
- IRCCS Ospedale San Raffaele
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Monza MI, Lombardy, Włochy, 20900
- Azienda Ospedaliera San Gerardo di Monza
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Rozzano (MI), Lombardy, Włochy, 20089
- Istituto Clinico Humanitas
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Veneto
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Negrar, Veneto, Włochy, 37024
- IRCCS Ospedale Sacro Cuore Don Calabria
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Leicester, Zjednoczone Królestwo, LE5 4PW
- Leicester General Hospital
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Llanrhystud, Zjednoczone Królestwo, SY23 1ER
- Bronglais General Hospital
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London, Zjednoczone Królestwo, SE5 9RS
- King College Hospital NHS Foundation Trust
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Stockport, Zjednoczone Królestwo, SK2 7JE
- Stepping Hill Hospital
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Afimkibart
Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection. |
Participants will receive afimkibart IV followed by afimkibart subcutaneous SC injection.
Inne nazwy:
|
|
Komparator placebo: Placebo
Participants will receive placebo IV followed by placebo SC. |
Placebo matching IV afimkibart. Placebo matching SC afimkibart. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Percentage of Participants with Clinical Remission
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Partial Modified Mayo Score (pmMS)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
|
Overall Change in UC Symptoms
Ramy czasowe: 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
|
|
Overall Severity in UC Symptoms
Ramy czasowe: 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
|
|
Incidence and Severity of Adverse Events (AEs)
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Clinical Trials, Hoffmann-La Roche
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- GA45330
- 2024-513015-27-00 (Ctis)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu 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
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .