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New hope for ulcerative colitis: phase 3 trial of afimkibart underway

NCT ID NCT06589986

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 15, 2026 · Updated 3 times

Summary

This Phase 3 trial tests whether the drug Afimkibart can help people with moderate-to-severe ulcerative colitis achieve remission. About 400 adults who have not responded well to other treatments will receive either Afimkibart or a placebo. The study measures remission at 12 and 52 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Afimkibart (a drug given by IV infusion or injection)
What this could lead to
If it works, this could offer a new treatment option to help people with ulcerative colitis reach and maintain remission.
What could go wrong
This is a late-stage trial, but results are not yet available. The drug may not work better than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Moderately to severely active ulcerative colitis

Contacts and locations

Locations

  • ASST Rhodense - Ospedale di Rho

    Rho, Lombardy, 20017, Italy

  • Accelerium S. de R.L. de C.V.

    Monterrey, Nuevo León, 64000, Mexico

  • Access Research Institute

    Brooksville, Florida, 34613, United States

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ, United Kingdom

  • Allied Biomedical Research Institute, Inc

    Miami, Florida, 33155, United States

  • Allied Gastrointestinal Associates, PA

    Flowood, Mississippi, 39232, United States

  • Allmedica Badania Kliniczne Sp z o.o. Sp K.

    Nowy Targ, 34-400, Poland

  • Anhui Provincial Hospital

    Hefei, 230001, China

  • Aoyama Clinic;GI Endoscopy & IBD Center

    Hyōgo, 650-0015, Japan

  • Auzmer Research

    Lakeland, Florida, 33813, United States

  • BR Trials - Pesquisa Clínica

    São Paulo, São Paulo, 03325-050, Brazil

  • Barmherzige Brüder Wien

    Vienna, 1020, Austria

  • Binzhou Medical university hospital

    Binzhou, China

  • Boca Clinical Trials Mexico S.C. (Guadalajara)

    Guadalajara, Jalisco, 44600, Mexico

  • Borzan Polyclinic

    Osijek, 31000, Croatia

  • Boston University

    Boston, Massachusetts, 02118, United States

  • Brigham & Womens Hosp

    Boston, Massachusetts, 02115, United States

  • CH Dptal Les Oudairies

    La Roche-sur-Yon, 85925, France

  • CHC MontLégia

    Liège, 4000, Belgium

  • CHRU de Lille - Hopital Claude Huriez

    Lille, 59037, France

  • CHU Amiens - Hopital Sud

    Amiens, 80054, France

  • CHU Bordeaux - Hôpital Haut-Lévêque

    Pessac, 33604, France

  • CHU Dijon Bourgogne Hôpital François Mitterand

    Dijon, 21000, France

  • CHU Nice - Hopital de l'Archet 2

    Nice, 06202, France

  • CHU Saint Etienne - Hôpital Nord

    Saint-Etienne, 42055, France

  • CHU de Liège (Sart Tilman)

    Liège, 4000, Belgium

  • CHU de Rennes - Hopital de Pontchaillo

    Rennes, 35033, France

  • CIPREC Centro de Investigacion y Prevencion Cardiovascular

    Ciudad Autonoma Buenos Aires, C1061AAS, Argentina

  • CPQuali Pesquisa Clinica Ltda

    São Paulo, São Paulo, 01228-000, Brazil

  • Cantacuzino Clinical Hospital

    Bucharest, 020475, Romania

  • Carta - Clinical Associates In Research Therapeutics Of America;LLC

    San Antonio, Texas, 78212, United States

  • Centralny Szpital Kliniczny MSW w Warszawie

    Warsaw, 02-507, Poland

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495, France

  • Centro Hospitalar de Entre Douro e Vouga - H. São Sebastião

    Santa Maria da Feira, 4520-211, Portugal

  • Centro Hospitalar do Algarve - Hospital de Portimao

    Portimão, 8500-338, Portugal

  • Centrum Medyczne "MEDYK"

    Rzeszów, 35-326, Poland

  • Centrum Medyczne "Medis"

    Bydgoszcz, 85-229, Poland

  • Centrum Medyczne Lukamed Joanna Luka-Wendrowska

    Chojnice, 89-600, Poland

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Clinexpert Kft.

    Budapest, 1033, Hungary

  • Clinfan Szolgaltato Kft.

    Szekszárd, 7100, Hungary

  • Clinica Universidad de Los Andes

    Santiago, Chile

  • Clinical Center Kragujevac

    Kragujevac, 34000, Serbia

  • Clinical Center of Vojvodina

    Novi Sad, 21137, Serbia

  • Clinical Research of Osceola, LLC

    Kissimmee, Florida, 34741, United States

  • Clinical Trials UMED Sp. z o. o.

    ?ód?, 92-213, Poland

  • Cliniq s.r.o.

    Bratislava, 811 09, Slovakia

  • Digestive Health Partners, PA

    Asheville, North Carolina, 28801, United States

  • Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan

    Dothan, Alabama, 36305, United States

  • Division of Gastroenterology, Depart of Internal Med, Siriraj H, Mahidol Uni

    Bangkok, 10700, Thailand

  • Division of Gastroenterology, Depart of Medicine, Fac of Med., Chulalongkorn University

    Bangkok, 10330, Thailand

  • Division of Gastroenterology, Depart of Medicine, Fac. of Med, Songklanagarind University

    Songkhla, 90110, Thailand

  • ETG Zamosc

    Zamo??, 22-400, Poland

  • Endo-Med Sp. z o.o.

    Karczew, 05-480, Poland

  • Endomed, s.r.o.

    Košice, 040 01, Slovakia

  • Expertia S.A- Mautalen Salud e Investigación

    Ciudad Autonoma Buenos Aires, C1128AAE, Argentina

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150, Australia

  • Florida Medical Clinic

    Zephyrhills, Florida, 33542, United States

  • Florida Research Institute - Lakewood

    Lakewood Rch, Florida, 34211, United States

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    Pavia, Lombardy, 27100, Italy

  • Fukuoka University Hospital

    Fukuoka, 814-0180, Japan

  • GI Alliance

    Garland, Texas, 75044, United States

  • Gastro Florida

    Clearwater, Florida, 33756, United States

  • Gastro Intestinal Research Institute of Northern Ohio

    Westlake, Ohio, 44145, United States

  • Gastro One

    Cordova, Tennessee, 38018, United States

  • Gastroenterologie s.r.o.

    Hradec Králové, 500 02, Czechia

  • Gastroenterology Associates of Central Georgia

    Macon, Georgia, 31201, United States

  • Gastroenterology Consultants of SWVA

    Roanoke, Virginia, 24018, United States

  • Gastroenterology Health Partners, PLLC

    New Albany, Indiana, 47150, United States

  • Gastroenterology Health Partners, PLLC

    Louisville, Kentucky, 40218, United States

  • Gastrointestinal Associates of Northeast Tennessee

    Johnson City, Tennessee, 37604, United States

  • Gastromed Sp. z o.o.

    Toru?, 87-100, Poland

  • Gokeikai Ofuna Chuo Hospital

    Kanagawa, 247-0056, Japan

  • Grand Teton Research Group, PLLC

    Idaho Falls, Idaho, 83404, United States

  • Gujarat Gastro and Vascular Hospital

    Surat, Gujarat, 395009, India

  • Guy's Hospital

    London, SE1 9RT, United Kingdom

  • Hebei Medical University - The Second Hospital

    Shijiazhuang, 050004, China

  • Herlev Hospital

    Herlev, 2730, Denmark

  • Hidaka Coloproctology Clinic

    Fukuoka, 839-0809, Japan

  • Homestead Associates in Research, Inc.

    Miami, Florida, 33033, United States

  • Hopital Nord

    Marseille, 13015, France

  • Hopital Robert Debre

    Reims, 51092, France

  • Hospital Guillermo Grant Benavente

    Concepción, 4030000, Chile

  • Hospital Sao Teotonio

    Viseu, 3504-509, Portugal

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008, Spain

  • Hospital da Luz Lisboa

    Lisbon, 1500-650, Portugal

  • Hospital de Braga

    Braga, 4710-243, Portugal

  • Hospital de Clinicas de Porto Alegre X

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • Hospital de Sao Joao

    Porto, 4202-451, Portugal

  • Huizhou First Hospital

    Huizhou, China

  • Hôpital de Rangueil

    Toulouse, 31400, France

  • Indiana University Health University Hospital

    Indianapolis, Indiana, 46202, United States

  • Institut des MICI, Clinique Ambroise Paré

    Neuilly-sur-Seine, 92200, France

  • Intercity Gastroenterology

    Fresh Meadows, New York, 11366, United States

  • Ishida Clinic of IBD and Gastroenterology

    Ōita, 870-0823, Japan

  • JCHO Tokyo Yamate Medical Center

    Tokyo, 169-0073, Japan

  • Japanese Red Cross Takayama Hospital

    Gifu, 506-8550, Japan

  • Jinhua municipal central hospital

    Jinhua, China

  • Jávorszky Ödön Kórház

    Vác, 2600, Hungary

  • Kagawa Prefectural Central Hospital

    Kagawa, 760-8557, Japan

  • Kiepury Clinic

    Sosnowiec, 41-200, Poland

  • Kitasato University Kitasato Institute Hospital

    Tokyo, 108-8642, Japan

  • Liver Research Unit, Srinagarind Hospital

    Khon Kaen, 40002, Thailand

  • Louisiana Research Center - GastroIntestinal Associates

    Shreveport, Louisiana, 71105, United States

  • Lyell McEwin Hospital

    Adelaide, South Australia, 5112, Australia

  • MHAT St. Ivan Rilski

    Gorna Oryahovitsa, 5100, Bulgaria

  • Mater Misericordiae Limited

    South Brisbane, Queensland, 4101, Australia

  • Matsuda Hospital

    Shizuoka, 432-8061, Japan

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425, United States

  • Medizinische Universität Innsbruck

    Innsbruck, 6020, Austria

  • Medwal

    Santiago, Chile

  • Melita Medical

    Wroclaw, 53-611, Poland

  • Miami Beach Clinical Research Center

    Miami Beach, Florida, 33141, United States

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112, United States

  • Nagasaki University Hospital

    Nagasaki, 852-8501, Japan

  • Nanjing 1st Hospital

    Nanjing, 210006, China

  • National Hospital Organization Osaka National Hospital

    Osaka, 540-0006, Japan

  • National Hospital Organization Shizuoka Medical Center

    Shizuoka, 411-8611, Japan

  • National Taiwan University Hospital

    Taipei, Zhongzheng District, 100, Taiwan

  • Nemocnice Ceske Budejovice a.s.

    České Budějovice, 370 01, Czechia

  • Obudai Egeszsegugyi Centrum Kft.

    Budapest, 1036, Hungary

  • Ohio Gastroenterology Group

    Columbus, Ohio, 43202, United States

  • Om Research LLC

    Lancaster, California, 93534, United States

  • Ospedale Madonna delle Grazie

    Matera, Basilicate, 75100, Italy

  • Pannonia Maganorvosi Centrum

    Budapest, 1136, Hungary

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907, United States

  • Peking University Shenzhen Hospital

    Shenzhen, 518036, China

  • Peking University Third Hospital

    Beijing, 100191, China

  • Penta Hospitals Przychodnie, Wroclaw Wejherowska

    Wroc?aw, 54-239, Poland

  • Peters Medical Research (PMR), LLC

    High Point, North Carolina, 27260, United States

  • Pioneer Clinical Research NY

    New York, New York, 10016, United States

  • Policlinico Universitario Agostino Gemelli

    Rome, Lazio, 00168, Italy

  • Ren Min Hospital Affiliated Wu Han University

    Wuhan, 430060, China

  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, 200127, China

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP, United Kingdom

  • Royal Prince Alfred Hospital

    Sydney, New South Wales, 2050, Australia

  • SOLUMED Centrum Medyczne

    Późna, 60-529, Poland

  • SPZOZ w ??cznej

    ??czna, 21-010, Poland

  • SR Kalla Memorial Gastro & General Hospital

    Jaipur, Rajasthan, 302006, India

  • Saga University Hospital

    Saga, 849-8501, Japan

  • Saga-ken Medical Centre Koseikan

    Saga, 840-8571, Japan

  • Sameshima Hospital

    Kagoshima, 892-0846, Japan

  • Shaare Zedek Medical Center

    Jerusalem, Bayit Vegan, 9103102, Israel

  • Sichuan Provincial People's Hospital

    Chengdu, 610072, China

  • South Edmonton Gastroenterology

    Edmonton, Alberta, T6K 4B2, Canada

  • Southern Star Research Institute, LLC.

    San Antonio, Texas, 78229, United States

  • SurGal Clinic s.r.o.

    Brno, 602 00, Czechia

  • Surat Institute of Digestive Sciences Hospitals

    Surat, Gujarat, 395002, India

  • Surin hospital

    Surin, 32000, Thailand

  • TDDC dba GI Alliance Research

    Mansfield, Texas, 76063, United States

  • Thammasat University Hospital

    Pathum Thani, 12120, Thailand

  • The 1st Affiliated Hospital of Nanchang Unversity

    Nanchang, 330006, China

  • The Canberra Hospital

    Garran, Australian Capital Territory, 2605, Australia

  • The First Affiliated Hospital Of Fujian Medical University

    Fuzhou, 350005, China

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, 230022, China

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, 510080, China

  • The Second Affiliated Hospital of Xi'an Jiao Tong University

    Xi'an, 710004, China

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, China

  • The University of Chicago

    Chicago, Illinois, 60637, United States

  • The University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75390, United States

  • The sixth affiliated hospital of Sun Yat-Sen University

    Guangzhou, 510655, China

  • Theia Clinical Research Centers, LLC

    Tampa, Florida, 33613, United States

  • Tidewater Gastroenterology Pllc T/A Gastro. Assoc. of Tidewater

    Chesapeake, Virginia, 23320, United States

  • Tokai University Hachioji Hospital

    Tokyo, 192-0032, Japan

  • Tri-State Gastroenterology Associates

    Crestview Hills, Kentucky, 41017-3409, United States

  • Tsujinaka Hospital Kashiwanoha

    Chiba, 277-0871, Japan

  • Tyler Research Institute, LLC

    Tyler, Texas, 75701, United States

  • Universita'degli Studi di Napoli Federico II

    Naples, Campania, 80131, Italy

  • Universitaetsklinikum Jena

    Jena, 77430, Germany

  • University Gastroenterology

    Providence, Rhode Island, 02904, United States

  • University Hospital Center Dr Dragisa Misovic - Dedinje

    Belgrade, 11040, Serbia

  • University Hospital Medical Center Bezanijska Kosa

    Belgrade, 11080, Serbia

  • University Hospital Medical Center Zvezdara

    Belgrade, 11120, Serbia

  • University of California Irvine

    Orange, California, 92868, United States

  • University of Texas Health Center at Tyler

    Tyler, Texas, 75708, United States

  • Vistamed & Vertigo Spó?Ka Z Ograniczon? Odpowiedzialno?Ci?

    Wroc?aw, 53-149, Poland

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 04-501, Poland

  • Wojewodzki Specjalistyczny Szpital w Olsztynie

    Olsztyn, 10-561, Poland

  • Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, 430022, China

  • Wuxi People's Hospital

    Wuxi, 214023, China

  • Yokohama City University Medical Center

    Yokohama, 232-0024, Japan

  • Zhuzhou Central Hospital

    Zhuzhou, China

  • the First Hospital of Jilin University

    Changchun, 130021, China

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