AzTrials
AzTrials

Moderately to Severely Active Ulcerative ColitisPhase 3Ametrine-1NCT06589986

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

A Phase 3 study testing Afimkibart in people with Moderately to Severely Active Ulcerative Colitis, run by Hoffmann-La Roche at 184 sites in 30 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 16 to 80 years
What is being tested?
Afimkibart
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
400 participants
Where
184 sitesin 30 countries
Study dates
17 Sep 2024to 30 Jan 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

184 sites in 30 countries.

184 sites in 30 countries

United States46 sites

  • Digestive Health Partners, PA

    Asheville, North Carolina, 28801

  • Brigham & Womens Hosp

    Boston, Massachusetts, 02115

  • Boston University

    Boston, Massachusetts, 02118

  • Access Research Institute

    Brooksville, Florida, 34613

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

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

    Chesapeake, Virginia, 23320

  • The University of Chicago

    Chicago, Illinois, 60637

  • Gastro Florida

    Clearwater, Florida, 33756

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907

  • Ohio Gastroenterology Group

    Columbus, Ohio, 43202

  • Gastro One

    Cordova, Tennessee, 38018

  • Tri-State Gastroenterology Associates

    Crestview Hills, Kentucky, 41017-3409

  • The University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75390

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

    Dothan, Alabama, 36305

  • Allied Gastrointestinal Associates, PA

    Flowood, Mississippi, 39232

  • Intercity Gastroenterology

    Fresh Meadows, New York, 11366

  • GI Alliance

    Garland, Texas, 75044

  • Peters Medical Research (PMR), LLC

    High Point, North Carolina, 27260

  • Grand Teton Research Group, PLLC

    Idaho Falls, Idaho, 83404

  • Indiana University Health University Hospital

    Indianapolis, Indiana, 46202

  • Gastrointestinal Associates of Northeast Tennessee

    Johnson City, Tennessee, 37604

  • Clinical Research of Osceola, LLC

    Kissimmee, Florida, 34741

  • Auzmer Research

    Lakeland, Florida, 33813

  • Florida Research Institute - Lakewood

    Lakewood Rch, Florida, 34211

  • Om Research LLC

    Lancaster, California, 93534

  • Gastroenterology Health Partners, PLLC

    Louisville, Kentucky, 40218

  • Gastroenterology Associates of Central Georgia

    Macon, Georgia, 31201

  • TDDC dba GI Alliance Research

    Mansfield, Texas, 76063

  • Homestead Associates in Research, Inc.

    Miami, Florida, 33033

  • Allied Biomedical Research Institute, Inc

    Miami, Florida, 33155

  • Miami Beach Clinical Research Center

    Miami Beach, Florida, 33141

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112

  • Gastroenterology Health Partners, PLLC

    New Albany, Indiana, 47150

  • Pioneer Clinical Research NY

    New York, New York, 10016

  • University of California Irvine

    Orange, California, 92868

  • University Gastroenterology

    Providence, Rhode Island, 02904

  • Gastroenterology Consultants of SWVA

    Roanoke, Virginia, 24018

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

    San Antonio, Texas, 78212

  • Southern Star Research Institute, LLC.

    San Antonio, Texas, 78229

  • Louisiana Research Center - GastroIntestinal Associates

    Shreveport, Louisiana, 71105

  • Theia Clinical Research Centers, LLC

    Tampa, Florida, 33613

  • Tyler Research Institute, LLC

    Tyler, Texas, 75701

  • University of Texas Health Center at Tyler

    Tyler, Texas, 75708

  • Gastro Intestinal Research Institute of Northern Ohio

    Westlake, Ohio, 44145

  • Florida Medical Clinic

    Zephyrhills, Florida, 33542

Other trials in United States

China22 sites

  • Peking University Third Hospital

    Beijing, 100191

  • Binzhou Medical university hospital

    Binzhou

  • the First Hospital of Jilin University

    Changchun, 130021

  • Sichuan Provincial People's Hospital

    Chengdu, 610072

  • The First Affiliated Hospital Of Fujian Medical University

    Fuzhou, 350005

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, 510080

  • The sixth affiliated hospital of Sun Yat-Sen University

    Guangzhou, 510655

  • Anhui Provincial Hospital

    Hefei, 230001

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, 230022

  • Huizhou First Hospital

    Huizhou

  • Jinhua municipal central hospital

    Jinhua

  • The 1st Affiliated Hospital of Nanchang Unversity

    Nanchang, 330006

  • Nanjing 1st Hospital

    Nanjing, 210006

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

    Shanghai, 200127

  • Peking University Shenzhen Hospital

    Shenzhen, 518036

  • Hebei Medical University - The Second Hospital

    Shijiazhuang, 050004

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

    Wuhan, 430022

  • Ren Min Hospital Affiliated Wu Han University

    Wuhan, 430060

  • Wuxi People's Hospital

    Wuxi, 214023

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

    Xi'an, 710004

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou

  • Zhuzhou Central Hospital

    Zhuzhou

Other trials in China

Japan19 sites

  • Tsujinaka Hospital Kashiwanoha

    Chiba, 277-0871

  • Fukuoka University Hospital

    Fukuoka, 814-0180

  • Hidaka Coloproctology Clinic

    Fukuoka, 839-0809

  • Japanese Red Cross Takayama Hospital

    Gifu, 506-8550

  • Aoyama Clinic;GI Endoscopy & IBD Center

    Hyōgo, 650-0015

  • Kagawa Prefectural Central Hospital

    Kagawa, 760-8557

  • Sameshima Hospital

    Kagoshima, 892-0846

  • Gokeikai Ofuna Chuo Hospital

    Kanagawa, 247-0056

  • Nagasaki University Hospital

    Nagasaki, 852-8501

  • Ishida Clinic of IBD and Gastroenterology

    Ōita, 870-0823

  • National Hospital Organization Osaka National Hospital

    Osaka, 540-0006

  • Saga-ken Medical Centre Koseikan

    Saga, 840-8571

  • Saga University Hospital

    Saga, 849-8501

  • National Hospital Organization Shizuoka Medical Center

    Shizuoka, 411-8611

  • Matsuda Hospital

    Shizuoka, 432-8061

  • Kitasato University Kitasato Institute Hospital

    Tokyo, 108-8642

  • JCHO Tokyo Yamate Medical Center

    Tokyo, 169-0073

  • Tokai University Hachioji Hospital

    Tokyo, 192-0032

  • Yokohama City University Medical Center

    Yokohama, 232-0024

Other trials in Japan

Poland17 sites

  • SPZOZ w ??cznej

    ??czna, 21-010

  • Clinical Trials UMED Sp. z o. o.

    ?ód?, 92-213

  • Centrum Medyczne "Medis"

    Bydgoszcz, 85-229

  • Centrum Medyczne Lukamed Joanna Luka-Wendrowska

    Chojnice, 89-600

  • Endo-Med Sp. z o.o.

    Karczew, 05-480

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

    Nowy Targ, 34-400

  • Wojewodzki Specjalistyczny Szpital w Olsztynie

    Olsztyn, 10-561

  • SOLUMED Centrum Medyczne

    Późna, 60-529

  • Centrum Medyczne "MEDYK"

    Rzeszów, 35-326

  • Kiepury Clinic

    Sosnowiec, 41-200

  • Gastromed Sp. z o.o.

    Toru?, 87-100

  • Centralny Szpital Kliniczny MSW w Warszawie

    Warsaw, 02-507

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 04-501

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

    Wroc?aw, 53-149

  • Penta Hospitals Przychodnie, Wroclaw Wejherowska

    Wroc?aw, 54-239

  • Melita Medical

    Wroclaw, 53-611

  • ETG Zamosc

    Zamo??, 22-400

Other trials in Poland

France13 sites

  • CHU Amiens - Hopital Sud

    Amiens, 80054

  • CHU Dijon Bourgogne Hôpital François Mitterand

    Dijon, 21000

  • CH Dptal Les Oudairies

    La Roche-sur-Yon, 85925

  • CHRU de Lille - Hopital Claude Huriez

    Lille, 59037

  • Hopital Nord

    Marseille, 13015

  • Institut des MICI, Clinique Ambroise Paré

    Neuilly-sur-Seine, 92200

  • CHU Nice - Hopital de l'Archet 2

    Nice, 06202

  • CHU Bordeaux - Hôpital Haut-Lévêque

    Pessac, 33604

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Hopital Robert Debre

    Reims, 51092

  • CHU de Rennes - Hopital de Pontchaillo

    Rennes, 35033

  • CHU Saint Etienne - Hôpital Nord

    Saint-Etienne, 42055

  • Hôpital de Rangueil

    Toulouse, 31400

Other trials in France

Portugal6 sites

  • Hospital de Braga

    Braga, 4710-243

  • Hospital da Luz Lisboa

    Lisbon, 1500-650

  • Centro Hospitalar do Algarve - Hospital de Portimao

    Portimão, 8500-338

  • Hospital de Sao Joao

    Porto, 4202-451

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

    Santa Maria da Feira, 4520-211

  • Hospital Sao Teotonio

    Viseu, 3504-509

Other trials in Portugal

Thailand6 sites

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

    Bangkok, 10330

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

    Bangkok, 10700

  • Liver Research Unit, Srinagarind Hospital

    Khon Kaen, 40002

  • Thammasat University Hospital

    Pathum Thani, 12120

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

    Songkhla, 90110

  • Surin hospital

    Surin, 32000

Other trials in Thailand

Australia5 sites

  • Lyell McEwin Hospital

    Adelaide, South Australia, 5112

  • The Canberra Hospital

    Garran, Australian Capital Territory, 2605

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Mater Misericordiae Limited

    South Brisbane, Queensland, 4101

  • Royal Prince Alfred Hospital

    Sydney, New South Wales, 2050

Other trials in Australia

Hungary5 sites

  • Clinexpert Kft.

    Budapest, 1033

  • Obudai Egeszsegugyi Centrum Kft.

    Budapest, 1036

  • Pannonia Maganorvosi Centrum

    Budapest, 1136

  • Clinfan Szolgaltato Kft.

    Szekszárd, 7100

  • Jávorszky Ödön Kórház

    Vác, 2600

Other trials in Hungary

Italy5 sites

  • Ospedale Madonna delle Grazie

    Matera, Basilicate, 75100

  • Universita'degli Studi di Napoli Federico II

    Naples, Campania, 80131

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    Pavia, Lombardy, 27100

  • ASST Rhodense - Ospedale di Rho

    Rho, Lombardy, 20017

  • Policlinico Universitario Agostino Gemelli

    Rome, Lazio, 00168

Other trials in Italy

Serbia5 sites

  • University Hospital Center Dr Dragisa Misovic - Dedinje

    Belgrade, 11040

  • University Hospital Medical Center Bezanijska Kosa

    Belgrade, 11080

  • University Hospital Medical Center Zvezdara

    Belgrade, 11120

  • Clinical Center Kragujevac

    Kragujevac, 34000

  • Clinical Center of Vojvodina

    Novi Sad, 21137

Other trials in Serbia

Brazil3 sites

  • Hospital de Clinicas de Porto Alegre X

    Porto Alegre, Rio Grande do Sul, 90035-903

  • CPQuali Pesquisa Clinica Ltda

    São Paulo, São Paulo, 01228-000

  • BR Trials - Pesquisa Clínica

    São Paulo, São Paulo, 03325-050

Other trials in Brazil

Chile3 sites

  • Hospital Guillermo Grant Benavente

    Concepción, 4030000

  • Clinica Universidad de Los Andes

    Santiago

  • Medwal

    Santiago

Other trials in Chile

Czechia3 sites

  • SurGal Clinic s.r.o.

    Brno, 602 00

  • Nemocnice Ceske Budejovice a.s.

    České Budějovice, 370 01

  • Gastroenterologie s.r.o.

    Hradec Králové, 500 02

Other trials in Czechia

India3 sites

  • SR Kalla Memorial Gastro & General Hospital

    Jaipur, Rajasthan, 302006

  • Surat Institute of Digestive Sciences Hospitals

    Surat, Gujarat, 395002

  • Gujarat Gastro and Vascular Hospital

    Surat, Gujarat, 395009

Other trials in India

United Kingdom3 sites

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP

  • Guy's Hospital

    London, SE1 9RT

Other trials in United Kingdom

Argentina2 sites

  • CIPREC Centro de Investigacion y Prevencion Cardiovascular

    Ciudad Autonoma Buenos Aires, C1061AAS

  • Expertia S.A- Mautalen Salud e Investigación

    Ciudad Autonoma Buenos Aires, C1128AAE

Other trials in Argentina

Austria2 sites

  • Medizinische Universität Innsbruck

    Innsbruck, 6020

  • Barmherzige Brüder Wien

    Vienna, 1020

Other trials in Austria

Belgium2 sites

  • CHC MontLégia

    Liège, 4000

  • CHU de Liège (Sart Tilman)

    Liège, 4000

Other trials in Belgium

Mexico2 sites

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

    Guadalajara, Jalisco, 44600

  • Accelerium S. de R.L. de C.V.

    Monterrey, Nuevo León, 64000

Other trials in Mexico

Slovakia2 sites

  • Cliniq s.r.o.

    Bratislava, 811 09

  • Endomed, s.r.o.

    Košice, 040 01

Other trials in Slovakia

Spain2 sites

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

Other trials in Spain

Bulgaria1 site

  • MHAT St. Ivan Rilski

    Gorna Oryahovitsa, 5100

Other trials in Bulgaria

Canada1 site

  • South Edmonton Gastroenterology

    Edmonton, Alberta, T6K 4B2

Other trials in Canada

Croatia1 site

  • Borzan Polyclinic

    Osijek, 31000

Other trials in Croatia

Denmark1 site

  • Herlev Hospital

    Herlev, 2730

Other trials in Denmark

Germany1 site

  • Universitaetsklinikum Jena

    Jena, 77430

Other trials in Germany

Israel1 site

  • Shaare Zedek Medical Center

    Jerusalem, Bayit Vegan, 9103102

Other trials in Israel

Romania1 site

  • Cantacuzino Clinical Hospital

    Bucharest, 020475

Other trials in Romania

Taiwan1 site

  • National Taiwan University Hospital

    Taipei, Zhongzheng District, 100

Other trials in Taiwan

About this study

Official title: 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).

Being tested
Afimkibart, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AfimkibartDrug

    Also called PF-06480605, RVT-3101, RG6631, RO7790121

    Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.

  • PlaceboDrug

    Placebo matching IV afimkibart. Placebo matching SC afimkibart.

Study groups in NCT06589986
Study groupRoleWhat they receive
AfimkibartExperimentalParticipants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.
Receives: Drug: Afimkibart
PlaceboPlacebo comparatorParticipants will receive placebo IV followed by placebo SC.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with Clinical Remission 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.

    Measured: At Week 12

  2. Percentage of Participants with Clinical Remission 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.

    Measured: At Week 52

Secondary outcomes (27)

  1. 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).

    Measured: Baseline to Week 2

  2. 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.

    Measured: At Week 12

  3. Percentage of Participants with Endoscopic Remission

    Percentage of participants achieving endoscopic subscore of 0 (normal appearance of mucosa) at Week 12.

    Measured: At Week 12

  4. 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).

    Measured: At Week 12

  5. 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).

    Measured: At Week 12

  6. 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).

    Measured: At Week 12

  7. Percentage of 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).

    Measured: At Week 12

  8. 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).

    Measured: At Week 12

  9. Percentage of Participants with Maintenance of Remission

    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.

    Measured: Week 12 and Week 52

  10. Percentage of Participants with Corticosteroid-Free Remission

    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.

    Measured: At Week 52

  11. 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 52.

    Measured: At Week 52

  12. Percentage of Participants with Endoscopic Remission

    Percentage of participants achieving endoscopic subscore of 0 (normal appearance of mucosa) at Week 52.

    Measured: At Week 52

  13. Percentage of Participants with Histologic Improvement

    Percentage of participants achieving histologic improvement defined as Geboes <= 3.1 at Week 52.

    Measured: At Week 52

  14. Percentage of Participants with Histologic Remission

    Percentage of participants achieving histologic remission defined as Geboes <2B at Week 52.

    Measured: At Week 52

  15. Percentage of 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 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).

    Measured: At Week 52

  16. 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 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).

    Measured: At Week 52

  17. 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.

    Measured: At Week 12

  18. 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 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.

    Measured: At Week 52

  19. 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.

    Measured: At Week 12

  20. 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 52 in biomarker-defined subgroups.

    Measured: At Week 52

  21. Change in Bowel Urgency

    Change in bowel urgency from baseline through Week 52. Bowel urgency is measured on a scale from 0 (None) to 4 (Severe).

    Measured: Baseline through Week 52

  22. Change in Abdominal Pain

    Change in abdominal pain from baseline through Week 52. Abdominal pain is measured on a scale from 0 (None) to 4 (Severe).

    Measured: Baseline through Week 52

  23. Change in Fatigue

    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.

    Measured: Baseline to Week 12 and Week 52

  24. Change in Health-Related Quality of Life

    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.

    Measured: Baseline to Week 12 and Week 52

  25. Overall Change in UC Symptoms

    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".

    Measured: Baseline to Week 2, Week 12, and Week 52

  26. Overall Severity in UC Symptoms

    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".

    Measured: Baseline to Week 2, Week 12, and Week 52

  27. 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.

    Measured: Up to 70 Weeks after Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start17 Sep 2024
  3. Primary completion30 Jan 2027 (estimated)
  4. Study completion30 Jan 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06589986
Sponsor's protocol ID
GA45329
Other IDs
2024-513014-35-00
Acronym
Ametrine-1
Status last verified
Sep 2026
First submitted
6 Sep 2024
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Afimkibart in people with Moderately to Severely Active Ulcerative Colitis, run by Hoffmann-La Roche at 184 sites in 30 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 184 sites in United States, China, Japan, Poland, France and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with Clinical Remission at Week 12 (time frame: At Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06589986.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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