A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis (Ametrine-2)

A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Patients With Moderately to Severely Active Ulcerative Colitis

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).

Study Overview

• Status: Recruiting
• Conditions: Moderately to Severely Active Ulcerative Colitis
• Intervention / Treatment: Drug: Placebo; Drug: Afimkibart

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: GA45330 https://forpatients.roche.com/; Phone Number: 888-662-6728 (U.S. and Canada); Email: global-roche-genentech-trials@gene.com
• Study Contact Backup: Name: Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Study Locations

• Argentina
  • Ciudad Autonoma Bs As, Argentina, C1280AEB
    • Recruiting
    • Hospital Britanico
  • Quilmes, Argentina, B1878DVB
    • Recruiting
    • Instituto Médico CER
• Australia
  • New South Wales
    • Macquarie Park, New South Wales, Australia, 2109
      • Active, not recruiting
      • Macquarie University Hospital
  • Queensland
    • Mackay, Queensland, Australia, 4740
      • Withdrawn
      • Coral Sea Clinical Research Institute
  • Victoria
    • Footscray, Victoria, Australia, 3011
      • Withdrawn
      • Footscray Hospital
    • Parkville, Victoria, Australia, 3050
      • Active, not recruiting
      • Royal Melbourne Hospital
• Austria
  • Linz, Austria, 4010
    • Active, not recruiting
    • Ordensklinikum Linz Barmherzige Schwestern
  • Wels, Austria, 4600
    • Withdrawn
    • Klinikum Wels-Grieskirchen
• Belgium
  • Aalst, Belgium, 9300
    • Withdrawn
    • AZORG Campus Aalst-Moorselbaan
  • Brussels, Belgium, 1200
    • Active, not recruiting
    • Cliniques Universitaires St-Luc
  • Brussels, Belgium, 1000
    • Active, not recruiting
    • CHU St Pierre (St Pierre)
  • Ostend, Belgium, 8400
    • Withdrawn
    • AZ Oostende
• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-000
      • Recruiting
      • Hospital Moinhos de Vento
  • Rio de Janeiro
    • Volta Redonda, Rio de Janeiro, Brazil, 27258-000
      • Recruiting
      • Instituto Lobus Unimed Volta Redonda
  • Sergipe
    • Aracaju, Sergipe, Brazil, 49055-000
      • Recruiting
      • Newdata Clinical Trials
  • São Paulo
    • Jaú, São Paulo, Brazil, 17210-190
      • Recruiting
      • CECIP - Centro de Estudos Clínicos do Interior Paulista
    • São Paulo, São Paulo, Brazil, 04266-010
      • Recruiting
      • Centro Paulista de Investigacao Clinica - CEPIC
    • São Paulo, São Paulo, Brazil, 01308-050
      • Recruiting
      • Hospital Sirio-Libanes
• Bulgaria
  • Plovdiv, Bulgaria, 4003
    • Recruiting
    • MC " Sveti Ivan Rilski Chudotvorets- 2010
  • Sofia, Bulgaria, 1407
    • Recruiting
    • "City Clinic UMHAC" EOOD
  • Sofia
    • Sofia Town, Sofia, Bulgaria, 1202
      • Withdrawn
      • Second Multiprofile Hospital For Active Treatment-Sofia
• Canada
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • Recruiting
      • Barrie GI Associates
    • Brampton, Ontario, Canada, L6S 0E2
      • Withdrawn
      • GNRR Digestive Clinics and Research Center Inc.
    • London, Ontario, Canada, N6A 5A5
      • Recruiting
      • London Health Sciences Centre Uni Campus
    • London, Ontario, Canada, N6K 1M6
      • Recruiting
      • LDDI Clinical Trials Inc.
    • Toronto, Ontario, Canada, M6A 3B4
      • Recruiting
      • TIDHI Innovation Inc.
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Recruiting
      • CIUSSS-de-l?Est-de-l?Île-de-Montréal
• Chile
  • Santiago, Chile, 8330034
    • Recruiting
    • Centro de Investigacion Clinica UC-CICUC
• China
  • Changsha, China, 410013
    • Recruiting
    • Third Xiangya Hospital Centrel South University
  • Chengdu, China, 610041
    • Recruiting
    • West China Hospital of Sichuan University
  • Guangzhou, China, 510180
    • Recruiting
    • Guangzhou First People's Hospital
  • Guangzhou, China, 510260
    • Recruiting
    • The Second Affiliated Hospital of Guangzhou Medical University
  • Hangzhou, China, 310016
    • Recruiting
    • Sir Run Run Shaw Hospital Zhejiang University
  • Huizhou, China, 516001
    • Recruiting
    • Huizhou Central People's Hospital
  • Nanchang, China, 330008
    • Recruiting
    • The Second Affiliated Hospital of Nanchang University
  • Nanning, China, 530021
    • Recruiting
    • The First Affiliate Hospital of Guangxi Medical University
  • Ningbo, China, 315000
    • Recruiting
    • The First Affiliated Hospital of Ningbo University
  • Qingdao, China, 266000
    • Recruiting
    • The Affiliated Hospital of Medical College Qingdao University
  • Shanghai, China, 200092
    • Recruiting
    • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Shanghai, China, 200025
    • Recruiting
    • Ruijin Hospital Shanghai Jiaotong University School of Medicine
  • Shenyang, China, 110004
    • Recruiting
    • Shengjing Hospital of China Medical University
  • Suzhou, China, 215006
    • Recruiting
    • First Affiliated Hospital of Soochow University
  • Xiamen, China, 361003
    • Recruiting
    • The First Affiliated Hospital of Xiamen University
  • Xiamen, China, 361004
    • Recruiting
    • Zhongshan Hospital Xiamen University
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100007
      • Recruiting
      • Beijing No.6 Hospital
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • Recruiting
      • The First Affilliated Hospital of Kunming Medical University
• Croatia
  • Osijek, Croatia, 31000
    • Recruiting
    • Borzan Polyclinic
  • Zagreb, Croatia, 10000
    • Recruiting
    • Clinical Hospital Center Sestre Milosrdnice
• Czechia
  • Hradec Králové, Czechia, 500 12
    • Recruiting
    • Hepato-gastroenterologie HK, s.r.o.
  • Ostrava - Poruba, Czechia, 708 52
    • Withdrawn
    • Fakultni nemocnice Ostrava
  • Prague, Czechia, 170 04
    • Recruiting
    • ISCARE a.s.
• Denmark
  • Aalborg, Denmark, 9000
    • Recruiting
    • Ålborg Universitets Hospital
• France
  • Chambray-lès-Tours, France, 37170
    • Recruiting
    • CHU Tours - Hôpital Trousseau
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • CHU Clermont Ferrand - Hôtel Dieu
  • Créteil, France, 94000
    • Recruiting
    • Hôpital Henri Mondor
  • Nîmes, France, 30900
    • Recruiting
    • Polyclinique Grand Sud
  • Vandœuvre-lès-Nancy, France, 54511
    • Recruiting
    • Hôpital de Brabois Adultes
• Germany
  • Heidelberg, Germany, 69120
    • Withdrawn
    • Universitätsklinikum Heidelberg
  • Lüneburg, Germany, 21339
    • Recruiting
    • Medizinisches Zentrum Klinikum Lueneburg
  • Potsdam, Germany, 14467
    • Withdrawn
    • Klinikum Ernst von Bergmann
• Hungary
  • Budapest, Hungary, 1082
    • Recruiting
    • Semmelweis Egyetem
  • Budapest, Hungary, 1062
    • Withdrawn
    • Észak-Pesti Centrumkórház-Honvédkórház
  • Debrecen, Hungary, 4025
    • Recruiting
    • Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
  • Szombathely, Hungary, 9700
    • Recruiting
    • Vas-Oxy Egeszsegugyi Kft
  • Székesfehérvár, Hungary, 8000
    • Recruiting
    • Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
• India
  • Gujarat
    • Surat, Gujarat, India, 395002
      • Recruiting
      • Surat Institute of Digestive Sciences Hospitals
    • Surat, Gujarat, India, 395009
      • Recruiting
      • Gujarat Gastro and Vascular Hospital
  • Maharashtra
    • Nagpur (urban), Maharashtra, India, 440018
      • Recruiting
      • MIDAS Multispeciality Hospital
    • Nagpur (urban), Maharashtra, India, 440001
      • Completed
      • Kingsway Hospital
    • Nashik, Maharashtra, India, 422001
      • Recruiting
      • Sahyadri Super Speciality Hospital
  • Rajasthan
    • Jaipur, Rajasthan, India, 302006
      • Recruiting
      • SR Kalla Memorial Gastro & General Hospital
    • Jaipur, Rajasthan, India, 302007
      • Recruiting
      • SMS Superspeciality Hospital
  • Telangana
    • Gachibowli, Telangana, India, 500032
      • Withdrawn
      • AIG Hospitals
    • Secunderabad, Telangana, India, 500003
      • Recruiting
      • Yashoda Hospitals
• Israel
  • Beersheba, Israel, 8410101
    • Recruiting
    • Soroka Medical Center
  • Ramat Gan, Israel, 5265601
    • Recruiting
    • The Chaim Sheba Medical Center
• Italy
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • Withdrawn
      • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
  • Lazio
    • Rome, Lazio, Italy, 00128
      • Recruiting
      • Policlinico Universitario Campus Biomedico Di Roma
    • Rome, Lazio, Italy, 00186
      • Recruiting
      • Ospedale Isola Tiberina Gemelli
  • Lombardy
    • Brescia, Lombardy, Italy, 25123
      • Recruiting
      • ASST degli Spedali Civili di Brescia
    • Milan, Lombardy, Italy, 20132
      • Recruiting
      • Irccs Ospedale San Raffaele
    • Monza MI, Lombardy, Italy, 20900
      • Recruiting
      • Azienda Ospedaliera San Gerardo di Monza
    • Rozzano (MI), Lombardy, Italy, 20089
      • Recruiting
      • Istituto Clinico Humanitas
  • Veneto
    • Negrar, Veneto, Italy, 37024
      • Recruiting
      • IRCCS Ospedale Sacro Cuore Don Calabria
• Mexico
  • Veracruz, Mexico, 91900
    • Recruiting
    • FAICIC S de R.L. de C.V
  • Mexico CITY (federal District)
    • Miguel Hidalgo, Mexico CITY (federal District), Mexico, 01120
      • Recruiting
      • Boca Clinical Trials Mexico S.C. (Cd. Mexico)
• Netherlands
  • Tilburg, Netherlands, 5022 GC
    • Active, not recruiting
    • ETZ Elisabeth
• Poland
  • ?ód?, Poland, 93-357
    • Active, not recruiting
    • Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi sp. z o.o.
  • Bia?ystok, Poland, 15-322
    • Withdrawn
    • Gastromed Kralisz, Romatowski, Stachurska sp.j.
  • Bydgoszcz, Poland, 85-231
    • Recruiting
    • Medical Center Kermed
  • Elblag, Poland, 82-300
    • Recruiting
    • Szpital Miejski sw. Jana Paw?a II w Elblagu
  • Grudzadz, Poland, 86-300
    • Withdrawn
    • Centrum Medyczne CLW-med Aneta Cichomska , Joanna Luka -Wendrowska
  • I?awa, Poland, 14-200
    • Recruiting
    • Osrodek Badan Klinicznych Bd Research
  • Knurów, Poland, 44-190
    • Active, not recruiting
    • MZ Badania Slowik Zymla Sp.j.
  • Krakow, Poland, 31-513
    • Active, not recruiting
    • Centrum Medyczne Promed
  • Lublin, Poland, 20-582
    • Recruiting
    • Medrise sp z o.o
  • Poznan, Poland, 61-731
    • Recruiting
    • Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
  • Późna, Poland, 60-309
    • Recruiting
    • EMC Instytut Medyczny SA
  • Późna, Poland, 61-441
    • Recruiting
    • Gabinety Lekarskie Rivermed
  • Sopot, Poland, 81-756
    • Recruiting
    • Endoskopia Sp. z o.o.
  • Szczecin, Poland, 71-685
    • Recruiting
    • Sonomed Sp. z o.o.
  • Warsaw, Poland, 00-189
    • Recruiting
    • Centrum Zdrowia-MDM
  • Warsaw, Poland, 02-679
    • Recruiting
    • Medon Clinical Research sp. z o.o
  • Warsaw, Poland, 03-580
    • Recruiting
    • Vivamed Spolka Z Ograniczona Odpowiedzialnoscia
  • Wroc?aw, Poland, 52-210
    • Recruiting
    • PlanetMed sp. z o.o.
  • Wroclaw, Poland, 52-416
    • Recruiting
    • Centrum Medyczne Oporow
• Portugal
  • Braga, Portugal, 4710-243
    • Recruiting
    • Hospital de Braga
  • Lisbon, Portugal, 1500-650
    • Recruiting
    • Hospital da Luz Lisboa
  • Portimão, Portugal, 8500-338
    • Recruiting
    • Centro Hospitalar do Algarve - Hospital de Portimao
  • Porto, Portugal, 4202-451
    • Recruiting
    • Hospital de Sao Joao
  • Santa Maria da Feira, Portugal, 4520-211
    • Recruiting
    • Centro Hospitalar de Entre Douro e Vouga - H. São Sebastião
  • Viseu, Portugal, 3504-509
    • Recruiting
    • Hospital Sao Teotonio
• Puerto Rico
  • San Juan, Puerto Rico, 00909
    • Recruiting
    • Klinical Investigations Group LLC
• Serbia
  • Zrenjanin, Serbia, 23000
    • Recruiting
    • General Hospital "Djordje Joanovic"
• Slovakia
  • Nitra, Slovakia, 949 01
    • Withdrawn
    • KM Management spol. s r.o.
  • Šahy, Slovakia, 936 01
    • Withdrawn
    • Accout Center s.r.o.
• Spain
  • Zaragoza, Spain, 50009
    • Active, not recruiting
    • Hospital Universitario Miguel Servet
  • Zaragoza, Spain, 50009
    • Withdrawn
    • Hospital Clinico Univ. Lozano Blesa
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Active, not recruiting
      • Hospital Universitario Puerta de Hierro Majadahonda
• Taiwan
  • Taichung, Taiwan, 40447
    • Recruiting
    • China Medical University Hospital
• Thailand
  • Chiang Mai, Thailand, 50200
    • Recruiting
    • Division of Gastroenterology, Depart of Internal Med., Fac of Med., Chiang Mai University
  • Chon Buri, Thailand, 20131
    • Recruiting
    • Burapha University Hospital
  • Ubonratchathani, Thailand, 34000
    • Recruiting
    • Sunpasitthiprasong Hospital
• United Kingdom
  • Leicester, United Kingdom, LE5 4PW
    • Recruiting
    • Leicester General Hospital
  • Llanrhystud, United Kingdom, SY23 1ER
    • Recruiting
    • Bronglais General Hospital
  • London, United Kingdom, SE5 9RS
    • Recruiting
    • King College Hospital NHS Foundation Trust
  • Peterborough, United Kingdom, PE 3 9GZ
    • Withdrawn
    • Peterborough City Hospital
  • Stockport, United Kingdom, SK2 7JE
    • Recruiting
    • Stepping Hill Hospital
  • Wolverhampton, United Kingdom, WV10 0QP
    • Recruiting
    • New Cross Hospital
• United States
  • Alabama
    • Dothan, Alabama, United States, 36305
      • Recruiting
      • Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Mayo Clinic Hospital
    • Sun City, Arizona, United States, 85351
      • Recruiting
      • Arizona Digestive Health, P.C (ADH)
  • California
    • Apple Valley, California, United States, 92307
      • Recruiting
      • Om Research LLC
    • Garden Grove, California, United States, 92845
      • Recruiting
      • Valley View Internal Medicine
    • Lancaster, California, United States, 93534
      • Recruiting
      • Gastro Care Associates
    • Los Angeles, California, United States, 90033-1057
      • Recruiting
      • University of Southern California
    • Newport Beach, California, United States, 92663
      • Recruiting
      • Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education
    • Redwood City, California, United States, 94063
      • Recruiting
      • Stanford Medicine Outpatient Center
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Recruiting
      • Peak Gastroenterology Associates
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Recruiting
      • Hi Tech and Global Research, LLC
    • Hialeah, Florida, United States, 33013
      • Recruiting
      • The Sister Life Research
    • Miami, Florida, United States, 33155
      • Recruiting
      • Allied Biomedical Research Institute
    • Miami, Florida, United States, 33126
      • Recruiting
      • LCC Medical Research Institute, LLC
    • Miami, Florida, United States, 33176
      • Withdrawn
      • Ambert Medical Research
    • Orlando, Florida, United States, 32825
      • Recruiting
      • Digestive and Liver Center of Florida
    • Orlando, Florida, United States, 32807
      • Recruiting
      • Integrity Trials LLC
    • Port Orange, Florida, United States, 32127
      • Recruiting
      • Advanced Medical Research Center
    • Tampa, Florida, United States, 33614
      • Recruiting
      • Guardian Angel Research Center, LLC
    • Tampa, Florida, United States, 33615
      • Recruiting
      • Santos Research Center, CORP
    • Tampa, Florida, United States, 33612
      • Recruiting
      • University of South Florida School of Medicine Morsani Center for Advanced Health Care
    • Weston, Florida, United States, 33331
      • Recruiting
      • Cleveland Clinic Florida
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Recruiting
      • Atlanta Gastroenterology Associates
    • Atlanta, Georgia, United States, 30308
      • Recruiting
      • Randomize Now, LLC
    • Macon, Georgia, United States, 31201
      • Recruiting
      • Gastroenterology Associates of Central Georgia
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Recruiting
      • Grand Teton Research Group, PLLC
  • Illinois
    • Glenview, Illinois, United States, 60026
      • Recruiting
      • Illinois Gastroenterology Group-Glenview powered by GI Alliance
    • Gurnee, Illinois, United States, 60031
      • Recruiting
      • Gi Alliance - Gurnee
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Recruiting
      • Gastro Health Partners, LLC
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Recruiting
      • Kansas Gastroenterology, LLC under Clinical Trials Network
  • Kentucky
    • Louisville, Kentucky, United States, 40218
      • Recruiting
      • One GI: GHP - Gastroenterology Health Partners Louisville
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
      • Recruiting
      • Louisiana Research Center - GastroIntestinal Associates
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Recruiting
      • Allied Gastrointestinal Associates, PA
    • Southaven, Mississippi, United States, 38671
      • Recruiting
      • Delta Gastroenterology & Endoscopy Center
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Recruiting
      • Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
  • New York
    • Brooklyn, New York, United States, 11215
      • Recruiting
      • Ellipsis Research Group
    • New York, New York, United States, 10021
      • Recruiting
      • Weill Cornell Medical College
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Inflammatory Bowel Disease Center
    • North Massapequa, New York, United States, 11758
      • Recruiting
      • DiGiovanna Inst for Med Ed&Res
    • Queens Village, New York, United States, 11428
      • Recruiting
      • Queens Village Medical Care
    • Rochester, New York, United States, 14618
      • Recruiting
      • Gastroenterology Group Of Rochester, LLP
    • The Bronx, New York, United States, 10468
      • Recruiting
      • James J Peters Veterans Administration Medical Center - NAVREF
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Recruiting
      • Charlotte Gastroenterology and Hepatology, P.L.L.C
    • Fuquay-Varina, North Carolina, United States, 27526
      • Recruiting
      • Omega Research North Carolina, LLC
    • High Point, North Carolina, United States, 27260
      • Recruiting
      • Peters Medical Research (PMR), LLC
  • Ohio
    • Beavercreek, Ohio, United States, 45440
      • Recruiting
      • Dayton Gastroenterology, Inc.
    • Cincinnati, Ohio, United States, 45267
      • Recruiting
      • University of Cincinnati Hospital
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University
    • Columbus, Ohio, United States, 43202
      • Recruiting
      • Ohio Gastroenterology Group
    • Westlake, Ohio, United States, 44145
      • Recruiting
      • Gastro Intestinal Research Institute of Northern Ohio
  • Pennsylvania
    • Uniontown, Pennsylvania, United States, 15401
      • Recruiting
      • Frontier Clinical Re search, LLC
  • Rhode Island
    • Providence, Rhode Island, United States, 02904
      • Recruiting
      • University Gastroenterology
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Recruiting
      • Gastroenterology Associates
  • Tennessee
    • Cordova, Tennessee, United States, 38018
      • Recruiting
      • Gastro One
  • Texas
    • Galveston, Texas, United States, 77555
      • Recruiting
      • Uni of Texas Medical Branch
    • Garland, Texas, United States, 75044
      • Recruiting
      • GI Alliance
    • Georgetown, Texas, United States, 78628
      • Recruiting
      • Amel Med LLC
    • Harlingen, Texas, United States, 78550
      • Recruiting
      • Texas Digestive Specialists
    • Harlingen, Texas, United States, 78550
      • Recruiting
      • Cano Medical Center
    • Houston, Texas, United States, 77090
      • Not yet recruiting
      • Integrity Advanced Therapeutics PLLC
    • Lubbock, Texas, United States, 79410
      • Recruiting
      • GI Alliance - Bay Area Gastroenterology
    • Mansfield, Texas, United States, 76063
      • Recruiting
      • TDDC dba GI Alliance Research
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Southern Star Research Institute, LLC.
    • Temple, Texas, United States, 76508
      • Recruiting
      • Baylor Scott and White Medical Center
    • Tyler, Texas, United States, 75701
      • Recruiting
      • Tyler Research Institute, LLC
    • Tyler, Texas, United States, 75708
      • Recruiting
      • University of Texas Health Center at Tyler
    • Webster, Texas, United States, 77598
      • Recruiting
      • TDDC GI Alliance research Webster
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Recruiting
      • Gastroenterology Associates of Tidewater
    • Lansdowne Town Center, Virginia, United States, 20176
      • Recruiting
      • Emeritas Research Group
    • Roanoke, Virginia, United States, 24018
      • Recruiting
      • Gastroenterology Consultants of SWVA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants will receive placebo IV followed by placebo SC.	Drug: Placebo; Placebo matching IV afimkibart. Placebo matching SC afimkibart.
Experimental: Afimkibart; Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.	Drug: Afimkibart; Participants will receive afimkibart IV followed by afimkibart subcutaneous SC injection.; Other Names: RVT-3101; PF-06480605; RG6631; RO7790121

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Clinical Remission	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Endoscopic Improvement	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	Percentage of participants achieving endoscopic subscore of 0 (normal appearance of mucosa) at Week 12.	At Week 12
Percentage of Participants with Clinical Response	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-Endoscopic Remission	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 Endoscopic Improvement: Among Biomarker-Defined Subgroups of Participants	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 Partial Modified Mayo Score (pmMS)	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
Participants with Histologic-Endoscopic Mucosal Improvement	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 Clinical Remission: Among Biomarker-Defined Subgroups of Participants	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
Change in Bowel Urgency	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	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	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	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	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	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)	Incidence and severity of AEs, including serious AEs, AEs leading to treatment discontinuation and AEs of special interest.	Up to 30 Weeks after Baseline
Percentage of Participants with Histologic Improvement	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	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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

Helpful Links

• Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2024
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2031

Study Registration Dates

• First Submitted: September 6, 2024
• First Submitted That Met QC Criteria: September 6, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Ulcer; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: GA45330; 2024-513015-27-00 (Ctis: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No