A Study to Assess the Efficacy and Safety of Afimkibart (Also Known as RO7790121) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (Ametrine-1)

March 18, 2026 updated by: Hoffmann-La Roche

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

This Phase III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Ciudad Autonoma Buenos Aires, Argentina, C1128AAE
        • Expertia S.A- Mautalen Salud e Investigación
      • Ciudad Autonoma Buenos Aires, Argentina, C1061AAS
        • Ciprec Centro de Investigacion y Prevencion Cardiovascular
  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • The Canberra Hospital
    • New South Wales
      • Sydney, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Mater Misericordiae Limited
    • South Australia
      • Adelaide, South Australia, Australia, 5112
        • Lyell McEwin Hospital
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital
  • Austria
      • Innsbruck, Austria, 6020
        • Medizinische Universitat Innsbruck
      • Vienna, Austria, 1090
        • Medizinische Universitat Wien
      • Vienna, Austria, 1020
        • Barmherzige Brüder Wien
  • Belgium
      • Ghent, Belgium, 9000
        • AZ Maria Middelares
      • Liège, Belgium, 4000
        • CHC MontLegia
      • Liège, Belgium, 4000
        • CHU de Liège (Sart Tilman)
  • Brazil
    • Paraná
      • Curitiba, Paraná, Brazil, 80430-160
        • Centro Digestivo de Curitiba
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre X
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01228-000
        • CPQuali Pesquisa Clinica Ltda
      • São Paulo, São Paulo, Brazil, 03325-050
        • BR Trials - Pesquisa Clínica
  • Bulgaria
      • Gorna Oryahovitsa, Bulgaria, 5100
        • MHAT St. Ivan Rilski
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6K 4B2
        • South Edmonton Gastroenterology
  • Chile
      • Concepción, Chile, 4030000
        • Hospital Guillermo Grant Benavente
      • Santiago, Chile
        • Clínica Universidad de Los Andes
      • Santiago, Chile
        • Medwal
  • China
      • Beijing, China, 100191
        • Peking University Third Hospital
      • Binzhou, China
        • Binzhou Medical University Hospital
      • Changchun, China, 130021
        • The First Hospital of Jilin University
      • Chengdu, China, 610072
        • Sichuan Provincial People's Hospital
      • Fuzhou, China, 350005
        • The First Affiliated Hospital of Fujian Medical University
      • Guangzhou, China, 510655
        • The Sixth Affiliated Hospital of Sun Yat-sen University
      • Guangzhou, China, 510080
        • The First Affiliated Hospital of Sun Yat-Sen University
      • Hefei, China, 230001
        • Anhui Provincial Hospital
      • Hefei, China, 230022
        • The First Affiliated Hospital of Anhui Medical University
      • Huizhou, China
        • Huizhou First Hospital
      • Jinhua, China
        • Jinhua municipal central hospital
      • Nanchang, China, 330006
        • The 1st Affiliated Hospital of Nanchang Unversity
      • Nanjing, China, 210006
        • Nanjing 1st Hospital
      • Shanghai, China, 200127
        • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
      • Shenzhen, China, 518036
        • Peking University Shenzhen Hospital
      • Shijiazhuang, China, 050004
        • Hebei Medical University - The Second Hospital
      • Tianjin, China, 300052
        • Tianjin Medical University General Hospital
      • Wuhan, China, 430060
        • Ren Min Hospital Affiliated Wu Han University
      • Wuhan, China, 430022
        • Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
      • Wuxi, China, 214023
        • Wuxi People's Hospital
      • Xi'an, China, 710004
        • The Second Affiliated Hospital of Xi'an Jiao Tong University
      • Zhengzhou, China
        • The Second Affiliated Hospital of Zhengzhou University
      • Zhuzhou, China
        • ZhuZhou Central Hospital
  • Croatia
      • Osijek, Croatia, 31000
        • Borzan Polyclinic
  • Czechia
      • Brno, Czechia, 602 00
        • SurGal Clinic s.r.o.
      • Hradec Králové, Czechia, 500 02
        • Gastroenterologie s.r.o.
      • České Budějovice, Czechia, 370 01
        • Nemocnice Ceske Budejovice a.s.
  • Denmark
      • Herlev, Denmark, 2730
        • Herlev Hospital
  • France
      • Amiens, France, 80054
        • CHU Amiens - Hopital Sud
      • Dijon, France, 21000
        • CHU Dijon Bourgogne Hôpital François Mitterand
      • La Roche-sur-Yon, France, 85925
        • CH Dptal Les Oudairies
      • Lille, France, 59037
        • CHRU de Lille - Hopital Claude Huriez
      • Marseille, France, 13015
        • Hopital Nord
      • Neuilly-sur-Seine, France, 92200
        • Institut des MICI, Clinique Ambroise Paré
      • Nice, France, 06202
        • CHU Nice - Hopital de l'Archet 2
      • Pessac, France, 33604
        • CHU Bordeaux - Hôpital Haut-Lévêque
      • Pierre-Bénite, France, 69495
        • Centre Hospitalier Lyon Sud
      • Reims, France, 51092
        • Hôpital Robert Debré
      • Rennes, France, 35033
        • CHU de Rennes - Hopital de Pontchaillo
      • Saint-Etienne, France, 42055
        • CHU Saint Etienne - Hopital Nord
      • Toulouse, France, 31400
        • Hopital de Rangueil
  • Germany
      • Jena, Germany, 77430
        • Universitaetsklinikum Jena
  • Hungary
      • Budapest, Hungary, 1033
        • Clinexpert Kft.
      • Budapest, Hungary, 1136
        • Pannónia Magánorvosi Centrum
      • Budapest, Hungary, 1036
        • Obudai Egeszsegugyi Centrum Kft.
      • Gyöngyös, Hungary, 3200
        • Clinexpert Gyongyos Kft
      • Szekszárd, Hungary, 7100
        • Clinfan Szolgaltato Kft.
      • Vác, Hungary, 2600
        • Javorszky Odon Korhaz
  • India
    • Gujarat
      • Surat, Gujarat, India, 395002
        • Surat Institute of Digestive Sciences Hospitals
      • Surat, Gujarat, India, 395009
        • Gujarat Gastro and Vascular Hospital
    • Rajasthan
      • Jaipur, Rajasthan, India, 302006
        • SR Kalla Memorial Gastro & General Hospital
  • Israel
    • Bayit Vegan
      • Jerusalem, Bayit Vegan, Israel, 9103102
        • Shaare Zedek Medical Center
  • Italy
    • Basilicate
      • Matera, Basilicate, Italy, 75100
        • Ospedale Madonna delle Grazie
    • Campania
      • Napoli, Campania, Italy, 80131
        • Universita'degli Studi di Napoli Federico II
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Policlinico Universitario Agostino Gemelli
    • Lombardy
      • Pavia, Lombardy, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo di Pavia
      • Rho, Lombardy, Italy, 20017
        • Asst Rhodense - Ospedale Di Rho
  • Japan
      • Chiba, Japan, 277-0871
        • Tsujinaka Hospital Kashiwanoha
      • Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital
      • Fukuoka, Japan, 839-0809
        • Hidaka Coloproctology Clinic
      • Gifu, Japan, 506-8550
        • Japanese Red Cross Takayama Hospital
      • Hyōgo, Japan, 650-0015
        • Aoyama Clinic;GI Endoscopy & IBD Center
      • Kagawa, Japan, 760-8557
        • Kagawa Prefectural Central Hospital
      • Kagoshima, Japan, 892-0846
        • Sameshima Hospital
      • Kanagawa, Japan, 247-0056
        • Gokeikai Ofuna Chuo Hospital
      • Nagasaki, Japan, 852-8501
        • Nagasaki University Hospital
      • Osaka, Japan, 540-0006
        • National Hospital Organization Osaka National Hospital
      • Saga, Japan, 840-8571
        • Saga-ken Medical Centre Koseikan
      • Saga, Japan, 849-8501
        • Saga University Hospital
      • Shizuoka, Japan, 432-8061
        • Matsuda Hospital
      • Shizuoka, Japan, 411-8611
        • National Hospital Organization Shizuoka Medical Center
      • Tokyo, Japan, 108-8642
        • Kitasato University Kitasato Institute Hospital
      • Tokyo, Japan, 169-0073
        • JCHO Tokyo Yamate Medical Center
      • Tokyo, Japan, 192-0032
        • Tokai University Hachioji Hospital
      • Yokohama, Japan, 232-0024
        • Yokohama City University Medical Center
      • Ōita, Japan, 870-0823
        • Ishida Clinic of IBD and Gastroenterology
  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44600
        • Boca Clinical Trials Mexico S.C. (Guadalajara)
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64000
        • Accelerium S. de R.L. de C.V.
    • Tlaxcala
      • Mexico, Tlaxcala, Mexico, 06726
        • Hospital General De Mexico
    • Yucatán
      • Mérida, Yucatán, Mexico, 97000
        • Medical Care & Research SA de CV
  • Poland
      • ??czna, Poland, 21-010
        • SPZOZ w ??cznej
      • ?ód?, Poland, 92-213
        • Clinical Trials UMED Sp. z o. o.
      • Bydgoszcz, Poland, 85-229
        • Centrum Medyczne "Medis"
      • Chojnice, Poland, 89-600
        • Centrum Medyczne Lukamed Joanna Luka-Wendrowska
      • Karczew, Poland, 05-480
        • Endo-Med Sp. z o.o.
      • Nowy Targ, Poland, 34-400
        • Allmedica Badania Kliniczne Sp z o.o. Sp K.
      • Olsztyn, Poland, 10-561
        • Wojewodzki Specjalistyczny Szpital w Olsztynie
      • Pabianice, Poland, 95-200
        • NZOZ Eskulap Pabianice
      • Późna, Poland, 60-529
        • SOLUMED Centrum Medyczne
      • Rzeszów, Poland, 35-326
        • Centrum Medyczne "MEDYK"
      • Sosnowiec, Poland, 41-200
        • Kiepury Clinic
      • Toru?, Poland, 87-100
        • GASTROMED Sp. z o.o.
      • Warsaw, Poland, 02-507
        • Centralny Szpital Kliniczny MSW w Warszawie
      • Warsaw, Poland, 04-501
        • WIP Warsaw IBD Point Profesor Kierkus
      • Wroc?aw, Poland, 53-149
        • Vistamed & Vertigo Spó?Ka Z Ograniczon? Odpowiedzialno?Ci?
      • Wroc?aw, Poland, 54-239
        • Penta Hospitals Przychodnie, Wroclaw Wejherowska
      • Wroclaw, Poland, 53-611
        • Melita Medical
      • Zamo??, Poland, 22-400
        • ETG Zamosc
  • Portugal
      • Braga, Portugal, 4710-243
        • Hospital de Braga
      • Lisbon, Portugal, 1500-650
        • Hospital da Luz Lisboa
      • Portimão, Portugal, 8500-338
        • Centro Hospitalar do Algarve - Hospital de Portimao
      • Porto, Portugal, 4202-451
        • Hospital de Sao Joao
      • Santa Maria da Feira, Portugal, 4520-211
        • Centro Hospitalar de Entre Douro e Vouga - H. São Sebastião
      • Viseu, Portugal, 3504-509
        • Hospital Sao Teotonio
  • Puerto Rico
      • San Juan, Puerto Rico, 00936-5067
        • University of Puerto Rico - Medical Science Campus
  • Romania
      • Bucharest, Romania, 020125
        • Colentina Clinical Hospital
      • Bucharest, Romania, 020475
        • Cantacuzino Clinical Hospital
  • Serbia
      • Belgrade, Serbia, 11080
        • Clinical Hospital Center Zemun
      • Belgrade, Serbia, 11080
        • University Hospital Medical Center Bezanijska kosa
      • Belgrade, Serbia, 11040
        • University Hospital Center Dr Dragisa Misovic - Dedinje
      • Belgrade, Serbia, 11120
        • University Hospital Medical Center Zvezdara
      • Kragujevac, Serbia, 34000
        • Clinical Center Kragujevac
      • Novi Sad, Serbia, 21137
        • Clinical Center of Vojvodina
  • Slovakia
      • Bratislava, Slovakia, 811 09
        • Cliniq s.r.o.
      • Košice, Slovakia, 040 01
        • Endomed, s.r.o.
  • Spain
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe de Valencia
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
  • Taiwan
    • Changhua County
      • Changhua, Changhua County, Taiwan, 50006
        • Changhua Christian Medical Foundation Changhua Christian Hospital
    • Zhongzheng District
      • Taipei, Zhongzheng District, Taiwan, 100
        • National Taiwan University Hospital
  • Thailand
      • Bangkok, Thailand, 10330
        • Division of Gastroenterology, Depart of Medicine, Fac of Med., Chulalongkorn University
      • Bangkok, Thailand, 10700
        • Division of Gastroenterology, Depart of Internal Med, Siriraj H, Mahidol Uni
      • Khon Kaen, Thailand, 40002
        • Liver Research Unit, Srinagarind Hospital
      • Pathum Thani, Thailand, 12120
        • Thammasat University Hospital
      • Songkhla, Thailand, 90110
        • Division of Gastroenterology, Depart of Medicine, Fac. of Med, Songklanagarind University
      • Surin, Thailand, 32000
        • Surin hospital
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrookes Hospital
      • Liverpool, United Kingdom, L7 8XP
        • Royal Liverpool University Hospital
      • London, United Kingdom, SE1 9RT
        • Guy's Hospital
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36305
        • Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan
    • Arizona
      • Sun City, Arizona, United States, 85351
        • Arizona Digestive Health, P.C (ADH)
    • California
      • Lancaster, California, United States, 93534
        • Om Research LLC
      • Los Angeles, California, United States, 90095
        • UCLA
      • Orange, California, United States, 92868
        • University of California Irvine
      • Redwood City, California, United States, 94063
        • Stanford Medicine Outpatient Center
      • San Diego, California, United States, 92120
        • Acclaim Clinical Research, Inc.
      • San Francisco, California, United States, 94115
        • UCSF/Medical Center at Mount Zion
      • Santa Clarita, California, United States, 91355
        • Amicis Research Center
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Peak Gastroenterology Associates
      • Lone Tree, Colorado, United States, 80124
        • Peak Gastroenterology Surgery Center
    • Florida
      • Brooksville, Florida, United States, 34613
        • Access Research Institute
      • Clearwater, Florida, United States, 33756
        • Gastro Florida
      • Coral Gables, Florida, United States, 33134
        • HealthMed Clinical Center Inc.
      • Doral, Florida, United States, 33126
        • J&A Clinical Research
      • Kissimmee, Florida, United States, 34741
        • Clinical Research of Osceola, LLC
      • Lakeland, Florida, United States, 33813
        • Auzmer Research
      • Lakewood Rch, Florida, United States, 34211
        • Florida Research Institute - Lakewood
      • Miami, Florida, United States, 33155
        • Allied Biomedical Research Institute, Inc
      • Miami, Florida, United States, 33033
        • Homestead Associates in Research, Inc.
      • Miami Beach, Florida, United States, 33141
        • Miami Beach Clinical Research Center
      • Miramar, Florida, United States, 33027
        • Eminat Research Group
      • Orlando, Florida, United States, 32806
        • Orlando Regional Healthcare
      • Tampa, Florida, United States, 33607
        • Nodal Medical Center, Llc
      • Tampa, Florida, United States, 33613
        • Theia Clinical Research Centers, LLC
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida
      • Zephyrhills, Florida, United States, 33542
        • Florida Medical Clinic
    • Georgia
      • Macon, Georgia, United States, 31201
        • Gastroenterology Associates of Central Georgia
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Grand Teton Research Group, PLLC
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
      • Chicago, Illinois, United States, 60637
        • The University of Chicago
      • Chicago, Illinois, United States, 60616
        • Next Innovative Clinical Research
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health University Hospital
      • New Albany, Indiana, United States, 47150
        • Gastroenterology Health Partners, PLLC
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017-3409
        • Tri-State Gastroenterology Associates
      • Louisville, Kentucky, United States, 40206
        • Robley Rex VA Medical Center
      • Louisville, Kentucky, United States, 40218
        • Gastroenterology Health Partners, PLLC
    • Louisiana
      • Shreveport, Louisiana, United States, 71105
        • Louisiana Research Center - GastroIntestinal Associates
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University
      • Boston, Massachusetts, United States, 02115
        • Brigham & Womens Hosp
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Michigan Center of Medical Research
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Allied Gastrointestinal Associates, PA
    • Missouri
      • Liberty, Missouri, United States, 64068
        • BVL Clinical Research
    • Nevada
      • North Las Vegas, Nevada, United States, 89030
        • Las Vegas Clinical Trials, LLC
    • New York
      • Fresh Meadows, New York, United States, 11366
        • Intercity Gastroenterology
      • Great Neck, New York, United States, 11021
        • Northwell Health Physician Partners Gastroenterology at Great Neck
      • New York, New York, United States, 10016
        • Pioneer Clinical Research NY
      • Richmond Hill, New York, United States, 11418
        • Mainstreet - Richmond Hill Clinic
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Digestive Health Partners, PA
      • High Point, North Carolina, United States, 27260
        • Peters Medical Research (PMR), LLC
      • Monroe, North Carolina, United States, 28112
        • Monroe Biomedical Research
    • Ohio
      • Brunswick, Ohio, United States, 44212
        • Digestive Disease Consultants
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43202
        • Ohio Gastroenterology Group
      • Mentor, Ohio, United States, 44060
        • Great Lakes Gastroenterology Research, LLC
      • Westlake, Ohio, United States, 44145
        • Gastro Intestinal Research Institute of Northern Ohio
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • University Gastroenterology
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina (MUSC)
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Gastro One
      • Johnson City, Tennessee, United States, 37604
        • Gastrointestinal Associates of Northeast Tennessee
      • Nashville, Tennessee, United States, 37211
        • Quality Medical Research
    • Texas
      • Cedar Park, Texas, United States, 78613
        • Texas Digestive Disease Consultants - Cedar Park
      • Dallas, Texas, United States, 75390
        • The University of Texas Southwestern Medical Center at Dallas
      • El Paso, Texas, United States, 79902
        • Proactive El Paso,LLC
      • Garland, Texas, United States, 75044
        • GI Alliance
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine.
      • Mansfield, Texas, United States, 76063
        • TDDC dba GI Alliance Research
      • Mesquite, Texas, United States, 75149
        • SMS Clinical Research, LLC
      • Pasadena, Texas, United States, 77505-3950
        • Digestive System Healthcare - Biopharma Informatic, LLC
      • San Antonio, Texas, United States, 78229
        • Southern Star Research Institute, LLC.
      • San Antonio, Texas, United States, 78212
        • Carta - Clinical Associates In Research Therapeutics Of America;LLC
      • Southlake, Texas, United States, 76092
        • GI Alliance - Southlake
      • Tyler, Texas, United States, 75708
        • University of Texas Health Center at Tyler
      • Tyler, Texas, United States, 75701
        • Tyler Research Institute, LLC
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Tidewater Gastroenterology Pllc T/A Gastro. Assoc. of Tidewater
      • Roanoke, Virginia, United States, 24018
        • Gastroenterology Consultants of SWVA
    • Washington
      • Vancouver, Washington, United States, 98664
        • The Vancouver Clinic
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • Marshall Health
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Univ of Wisconsin Hosp & Clin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Other Names:
  • RVT-3101
  • PF-06480605
  • RG6631
  • RO7790121

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Clinical Remission at Week 12
Time Frame: 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
Percentage of Participants with Clinical Remission at Week 52
Time Frame: At Week 52
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 52. 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 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Partial Modified Mayo Score (pmMS)
Time Frame: 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).
Baseline to Week 2
Percentage of Participants with Endoscopic Improvement
Time Frame: 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
Time Frame: 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
Time Frame: 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-Endoscopic Mucosal Improvement
Time Frame: 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
Time Frame: 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 Maintenance of Remission
Time Frame: Week 12 and Week 52
Percentage of participants with clinical remission at both Week 12 and Week 52. Clinical remission is defined as 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). 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.
Week 12 and Week 52
Percentage of Participants with Corticosteroid-Free Remission
Time Frame: At Week 52
Percentage of participants in clinical remission at Week 52 with no corticosteroid use at least 8 weeks prior to Week 52. Clinical remission is defined as 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). 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 52
Percentage of Participants with Endoscopic Improvement
Time Frame: At Week 52
Percentage of participants achieving endoscopic subscore of 0 or 1 (normal appearance of mucosa or mild disease) at Week 52.
At Week 52
Percentage of Participants with Endoscopic Remission
Time Frame: At Week 52
Percentage of participants achieving endoscopic subscore of 0 (normal appearance of mucosa) at Week 52.
At Week 52
Percentage of Participants with Histologic-Endoscopic Mucosal Improvement
Time Frame: At Week 52
Percentage of participants achieving Geboes <= 3.1 and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 52. 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 52
Percentage of Participants with Histologic-Endoscopic Remission
Time Frame: At Week 52
Percentage of participants achieving Geboes < 2 and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 52. 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 52
Percentage of Participants with Clinical remission: Among Biomarker-Defined Subgroups of Participants
Time Frame: 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 Clinical remission: Among Biomarker-Defined Subgroups of Participants
Time Frame: At Week 52
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 52 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 52
Percentage of Participants with Endoscopic Improvement: Among Biomarker-Defined Subgroups of Participants
Time Frame: 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
Percentage of Participants with Endoscopic Improvement: Among Biomarker-Defined Subgroups of Participants
Time Frame: At Week 52
Percentage of participants achieving endoscopic subscore of 0 or 1 (normal appearance of mucosa or mild disease) at Week 52 in biomarker-defined subgroups.
At Week 52
Change in Bowel Urgency
Time Frame: Baseline through Week 52
Change in bowel urgency from baseline through Week 52. Bowel urgency is measured on a scale from 0 (None) to 4 (Severe).
Baseline through Week 52
Change in Abdominal Pain
Time Frame: Baseline through Week 52
Change in abdominal pain from baseline through Week 52. Abdominal pain is measured on a scale from 0 (None) to 4 (Severe).
Baseline through Week 52
Change in Fatigue
Time Frame: Baseline to Week 12 and Week 52
Change in fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) from baseline to Week 12 and Week 52. 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 and Week 52
Change in Health-Related Quality of Life
Time Frame: Baseline to Week 12 and Week 52
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) score from baseline to Week 12 and Week 52. 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 and Week 52
Overall Change in UC Symptoms
Time Frame: Baseline to Week 2, Week 12, and Week 52
Patient Global Impression of Change (PGIC) from baseline to Weeks 2, 12 and 52. PGIC measures overall change in ulcerative colitis symptoms from "Much better" to "Much worse".
Baseline to Week 2, Week 12, and Week 52
Overall Severity in UC Symptoms
Time Frame: Baseline to Week 2, Week 12, and Week 52
Patient Global Impression of Severity (PGIS) from baseline to Weeks 2, 12 and 52. PGIS measures severity of ulcerative colitis symptoms from "None" to "Very severe".
Baseline to Week 2, Week 12, and Week 52
Incidence and Severity of Adverse Events (AEs)
Time Frame: Up to 70 Weeks after Baseline
Incidence and severity of AEs, including serious AEs, AEs leading to treatment discontinuation and AEs of special interest.
Up to 70 Weeks after Baseline
Percentage of Participants with Histologic Improvement
Time Frame: 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
Time Frame: 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
Percentage of Participants with Histologic Improvement
Time Frame: At Week 52
Percentage of participants achieving histologic improvement defined as Geboes <= 3.1 at Week 52.
At Week 52
Percentage of Participants with Histologic Remission
Time Frame: At Week 52
Percentage of participants achieving histologic remission defined as Geboes <2B at Week 52.
At Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chugai Pharmaceutical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 17, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GA45329
  • 2024-513014-35-00 (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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