Uno studio per valutare l'efficacia e la sicurezza della terapia di induzione con RO7790121 in partecipanti con colite ulcerosa attiva da moderatamente a gravemente (Ametrine-2)
1 ottobre 2026 aggiornato da: Hoffmann-La Roche
Uno studio di fase III, multicentrico, in doppio cieco, controllato con placebo per valutare l'efficacia e la sicurezza della terapia di induzione con RO7790121 in pazienti con colite ulcerosa attiva da moderatamente a gravemente
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).
Panoramica dello studio
Stato
Stato
Attivo, non reclutante
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Interventistico
Iscrizione (Stimato)
Iscrizione
350
Fase
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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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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Brussels, Belgio, 1000
- CHU St Pierre (St Pierre)
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Brussels, Belgio, 1200
- Cliniques Universitaires St-Luc
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasile, 90035-000
- Hospital Moinhos de Vento
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Rio de Janeiro
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Volta Redonda, Rio de Janeiro, Brasile, 27258-000
- Instituto Lobus Unimed Volta Redonda
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Sergipe
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Aracaju, Sergipe, Brasile, 49055-000
- Newdata Clinical Trials
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São Paulo
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Jaú, São Paulo, Brasile, 17210-190
- CECIP - Centro de Estudos Clínicos do Interior Paulista
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São Paulo, São Paulo, Brasile, 04266-010
- Centro Paulista de Investigacao Clinica - CEPIC
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Plovdiv, Bulgaria, 4003
- MC " Sveti Ivan Rilski Chudotvorets- 2010
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Sofia, Bulgaria, 1407
- "City Clinic UMHAC" EOOD
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Ontario
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Barrie, Ontario, Canada, L4M 7G1
- Barrie GI Associates
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London, Ontario, Canada, N6A 5A5
- London Health Sciences Centre Uni Campus
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London, Ontario, Canada, N6K 1M6
- LDDI Clinical Trials Inc.
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Toronto, Ontario, Canada, M6A 3B4
- TIDHI Innovation Inc.
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Quebec
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Montreal, Quebec, Canada, H1T 2M4
- CIUSSS-de-l?Est-de-l?Île-de-Montréal
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Hradec Králové, Cechia, 500 12
- Hepato-Gastroenterologie HK, s.r.o.
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Prague, Cechia, 170 04
- ISCARE a.s.
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Santiago, Chile, 8330034
- Centro de Investigación Clínica UC-CICUC
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Changsha, Cina, 410013
- Third Xiangya Hospital Centrel South University
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Chengdu, Cina, 610041
- West China Hospital of Sichuan University
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Guangzhou, Cina, 510180
- Guangzhou First People's Hospital
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Guangzhou, Cina, 510260
- The second Affiliated Hospital of Guangzhou Medical University
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Hangzhou, Cina, 310016
- Sir Run Run Shaw Hospital Zhejiang University
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Huizhou, Cina, 516001
- Huizhou Central People's Hospital
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Nanning, Cina, 530021
- The First Affiliate Hospital of Guangxi Medical University
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Ningbo, Cina, 315000
- The First Affiliated Hospital of Ningbo University
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Qingdao, Cina, 266000
- The Affiliated Hospital of Medical College Qingdao University
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Shanghai, Cina, 200092
- Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
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Shanghai, Cina, 200025
- Ruijin Hospital Shanghai Jiaotong University School of Medicine
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Shenyang, Cina, 110004
- Shengjing Hospital of China Medical University
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Suzhou, Cina, 215006
- First Affiliated Hospital of Soochow University
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Xiamen, Cina, 361004
- Zhongshan Hospital Xiamen University
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Beijing Municipality
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Beijing, Beijing Municipality, Cina, 100007
- Beijing No.6 Hospital
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Yunnan
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Kunming, Yunnan, Cina, 650032
- The First Affilliated Hospital of Kunming Medical University
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Osijek, Croazia, 31000
- Borzan Polyclinic
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Aalborg, Danimarca, 9000
- Ålborg Universitets Hospital
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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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Lüneburg, Germania, 21339
- Medizinisches Zentrum Klinikum Lueneburg
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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, Israele, 8410101
- Soroka Medical Center
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Ramat Gan, Israele, 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, Messico, 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), Messico, 01120
- Boca Clinical Trials Mexico S.C. (Cd. Mexico)
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Tilburg, Olanda, 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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San Juan, Porto Rico, 00909
- Klinical Investigations Group LLC
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Braga, Portogallo, 4710-243
- Hospital de Braga
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Lisbon, Portogallo, 1500-650
- Hospital da Luz Lisboa
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Portimão, Portogallo, 8500-338
- Centro Hospitalar do Algarve - Hospital de Portimao
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Porto, Portogallo, 4202-451
- Hospital de Sao Joao
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Santa Maria da Feira, Portogallo, 4520-211
- Centro Hospitalar de Entre Douro e Vouga - H. São Sebastião
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Viseu, Portogallo, 3504-509
- Hospital Sao Teotonio
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Leicester, Regno Unito, LE5 4PW
- Leicester General Hospital
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Llanrhystud, Regno Unito, SY23 1ER
- Bronglais General Hospital
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London, Regno Unito, SE5 9RS
- King College Hospital NHS Foundation Trust
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Stockport, Regno Unito, SK2 7JE
- Stepping Hill Hospital
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Zrenjanin, Serbia, 23000
- General Hospital "Djordje Joanovic"
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Zaragoza, Spagna, 50009
- Hospital Universitario Miguel Servet
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Madrid
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Majadahonda, Madrid, Spagna, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
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Alabama
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Dothan, Alabama, Stati Uniti, 36305
- Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan
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Arizona
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Scottsdale, Arizona, Stati Uniti, 85259
- Mayo Clinic Hospital
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Sun City, Arizona, Stati Uniti, 85351
- Arizona Digestive Health, P.C (ADH)
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California
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Apple Valley, California, Stati Uniti, 92307
- Om Research LLC
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Garden Grove, California, Stati Uniti, 92845
- Valley View Internal Medicine
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Lancaster, California, Stati Uniti, 93534
- Gastro Care Associates
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Redwood City, California, Stati Uniti, 94063
- Stanford Medicine Outpatient Center
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Colorado
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Colorado Springs, Colorado, Stati Uniti, 80907
- Peak Gastroenterology Associates
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Florida
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Coral Gables, Florida, Stati Uniti, 33134
- Hi Tech and Global Research, LLC
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Hialeah, Florida, Stati Uniti, 33013
- The Sister Life Research
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Miami, Florida, Stati Uniti, 33155
- Allied Biomedical Research Institute
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Miami, Florida, Stati Uniti, 33126
- LCC Medical Research Institute, LLC
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Orlando, Florida, Stati Uniti, 32825
- Digestive and Liver Center of Florida
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Orlando, Florida, Stati Uniti, 32807
- Integrity Trials LLC
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Port Orange, Florida, Stati Uniti, 32127
- Advanced Medical Research Center
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Tampa, Florida, Stati Uniti, 33612
- University of South Florida School of Medicine Morsani Center for Advanced Health Care
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Tampa, Florida, Stati Uniti, 33615
- Santos Research Center, CORP
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Tampa, Florida, Stati Uniti, 33614
- Guardian Angel Research Center, LLC
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Weston, Florida, Stati Uniti, 33331
- Cleveland Clinic Florida
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Georgia
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Atlanta, Georgia, Stati Uniti, 30342
- Atlanta Gastroenterology Associates
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Atlanta, Georgia, Stati Uniti, 30308
- Randomize Now, LLC
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Macon, Georgia, Stati Uniti, 31201
- Gastroenterology Associates of Central Georgia
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Illinois
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Glenview, Illinois, Stati Uniti, 60026
- Illinois Gastroenterology Group-Glenview powered by GI Alliance
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Gurnee, Illinois, Stati Uniti, 60031
- GI Alliance - Gurnee
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Indiana
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New Albany, Indiana, Stati Uniti, 47150
- Gastro Health Partners, LLC
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Kansas
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Wichita, Kansas, Stati Uniti, 67226
- Kansas Gastroenterology, LLC under Clinical Trials Network
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Kentucky
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Louisville, Kentucky, Stati Uniti, 40218
- One GI: GHP - Gastroenterology Health Partners Louisville
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Louisiana
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Shreveport, Louisiana, Stati Uniti, 71105
- Louisiana Research Center - GastroIntestinal Associates
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Mississippi
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Flowood, Mississippi, Stati Uniti, 39232
- Allied Gastrointestinal Associates, PA
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New Hampshire
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Lebanon, New Hampshire, Stati Uniti, 03756
- Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
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New York
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Brooklyn, New York, Stati Uniti, 11215
- Ellipsis Research Group
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New York, New York, Stati Uniti, 10021
- Weill Cornell Medical College
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New York, New York, Stati Uniti, 10016
- NYU Inflammatory Bowel Disease Center
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North Massapequa, New York, Stati Uniti, 11758
- DiGiovanna Inst for Med Ed&Res
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Queens Village, New York, Stati Uniti, 11428
- Queens Village Medical Care
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Rochester, New York, Stati Uniti, 14618
- Gastroenterology Group Of Rochester, LLP
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North Carolina
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Charlotte, North Carolina, Stati Uniti, 28207
- Charlotte Gastroenterology and Hepatology, P.L.L.C
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Fuquay-Varina, North Carolina, Stati Uniti, 27526
- Omega Research North Carolina, LLC
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High Point, North Carolina, Stati Uniti, 27260
- Peters Medical Research (PMR), LLC
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Ohio
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Beavercreek, Ohio, Stati Uniti, 45440
- Dayton Gastroenterology, Inc.
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Cincinnati, Ohio, Stati Uniti, 45267
- University of Cincinnati Hospital
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Cleveland, Ohio, Stati Uniti, 44195
- Cleveland Clinic Foundation
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Columbus, Ohio, Stati Uniti, 43210
- Ohio State University
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Columbus, Ohio, Stati Uniti, 43202
- Ohio Gastroenterology Group
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Westlake, Ohio, Stati Uniti, 44145
- Gastro Intestinal Research Institute of Northern Ohio
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Pennsylvania
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Uniontown, Pennsylvania, Stati Uniti, 15401
- Frontier Clinical Re search, LLC
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Rhode Island
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Providence, Rhode Island, Stati Uniti, 02904
- University Gastroenterology
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South Carolina
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Greenville, South Carolina, Stati Uniti, 29607
- Gastroenterology Associates
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Tennessee
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Cordova, Tennessee, Stati Uniti, 38018
- Gastro One
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Texas
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Galveston, Texas, Stati Uniti, 77555
- Uni of Texas Medical Branch
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Garland, Texas, Stati Uniti, 75044
- GI Alliance
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Georgetown, Texas, Stati Uniti, 78628
- Amel Med LLC
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Harlingen, Texas, Stati Uniti, 78550
- Texas Digestive Specialists
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Harlingen, Texas, Stati Uniti, 78550
- Cano Medical Center
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Lubbock, Texas, Stati Uniti, 79410
- GI Alliance - Bay Area Gastroenterology
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Mansfield, Texas, Stati Uniti, 76063
- TDDC dba GI Alliance Research
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San Antonio, Texas, Stati Uniti, 78229
- Southern Star Research Institute, LLC.
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Temple, Texas, Stati Uniti, 76508
- Baylor Scott and White Medical Center
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Tyler, Texas, Stati Uniti, 75708
- University of Texas Health Center at Tyler
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Tyler, Texas, Stati Uniti, 75701
- Tyler Research Institute, LLC
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Webster, Texas, Stati Uniti, 77598
- TDDC GI Alliance research Webster
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Virginia
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Chesapeake, Virginia, Stati Uniti, 23320
- Gastroenterology Associates of Tidewater
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Lansdowne Town Center, Virginia, Stati Uniti, 20176
- Emeritas Research Group
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Roanoke, Virginia, Stati Uniti, 24018
- Gastroenterology Consultants of SWVA
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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, Taiwan, 40447
- China Medical University Hospital
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Budapest, Ungheria, 1082
- Semmelweis Egyetem
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Debrecen, Ungheria, 4025
- Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
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Szombathely, Ungheria, 9700
- Vas-Oxy Egeszsegugyi Kft
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Székesfehérvár, Ungheria, 8000
- Fejer Varmegyei Szent György Egyetemi Oktatokorhaz
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Da 16 anni a 80 anni (Bambino, Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Numero di armi
2
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Sperimentale: Afimkibart
Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection. |
Participants will receive afimkibart IV followed by afimkibart subcutaneous SC injection.
Altri nomi:
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Comparatore placebo: Placebo
Participants will receive placebo IV followed by placebo SC. |
Placebo matching IV afimkibart. Placebo matching SC afimkibart. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of Participants with Clinical Remission
Lasso di tempo: 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
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Partial Modified Mayo Score (pmMS)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Sponsor
Investigatori
Investigatori
- Direttore dello studio: Clinical Trials, Hoffmann-La Roche
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
11 dicembre 2024
Completamento primario (Stimato)
Completamento primario
29 ottobre 2026
Completamento dello studio (Stimato)
Completamento dello studio
30 gennaio 2031
Date di iscrizione allo studio
Primo inviato
Primo inviato
6 settembre 2024
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
6 settembre 2024
Primo Inserito (Effettivo)
Primo Inserito
19 settembre 2024
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
2 ottobre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
1 ottobre 2026
Ultimo verificato
Ultimo verificato
1 ottobre 2026
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- GA45330
- 2024-513015-27-00 (Ctis)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano 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
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .