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AzTrials

Moderately to Severely Active Ulcerative ColitisPhase 3Ametrine-2NCT06588855

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

A Phase 3 study testing Afimkibart in people with Moderately to Severely Active Ulcerative Colitis, run by Hoffmann-La Roche at 168 sites in 29 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 study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC). 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
350 participants
Where
168 sitesin 29 countries
Study dates
11 Dec 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

168 sites in 29 countries.

168 sites in 29 countries

United States64 sites

  • Om Research LLC

    Apple Valley, California, 92307

  • Randomize Now, LLC

    Atlanta, Georgia, 30308

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30342

  • Dayton Gastroenterology, Inc.

    Beavercreek, Ohio, 45440

  • Ellipsis Research Group

    Brooklyn, New York, 11215

  • Charlotte Gastroenterology and Hepatology, P.L.L.C

    Charlotte, North Carolina, 28207

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia, 23320

  • University of Cincinnati Hospital

    Cincinnati, Ohio, 45267

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907

  • Ohio Gastroenterology Group

    Columbus, Ohio, 43202

  • Ohio State University

    Columbus, Ohio, 43210

  • Hi Tech and Global Research, LLC

    Coral Gables, Florida, 33134

  • Gastro One

    Cordova, Tennessee, 38018

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

    Dothan, Alabama, 36305

  • Allied Gastrointestinal Associates, PA

    Flowood, Mississippi, 39232

  • Omega Research North Carolina, LLC

    Fuquay-Varina, North Carolina, 27526

  • Uni of Texas Medical Branch

    Galveston, Texas, 77555

  • Valley View Internal Medicine

    Garden Grove, California, 92845

  • GI Alliance

    Garland, Texas, 75044

  • Amel Med LLC

    Georgetown, Texas, 78628

  • Illinois Gastroenterology Group-Glenview powered by GI Alliance

    Glenview, Illinois, 60026

  • Gastroenterology Associates

    Greenville, South Carolina, 29607

  • GI Alliance - Gurnee

    Gurnee, Illinois, 60031

  • Cano Medical Center

    Harlingen, Texas, 78550

  • Texas Digestive Specialists

    Harlingen, Texas, 78550

  • The Sister Life Research

    Hialeah, Florida, 33013

  • Peters Medical Research (PMR), LLC

    High Point, North Carolina, 27260

  • Gastro Care Associates

    Lancaster, California, 93534

  • Emeritas Research Group

    Lansdowne Town Center, Virginia, 20176

  • Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756

  • One GI: GHP - Gastroenterology Health Partners Louisville

    Louisville, Kentucky, 40218

  • GI Alliance - Bay Area Gastroenterology

    Lubbock, Texas, 79410

  • Gastroenterology Associates of Central Georgia

    Macon, Georgia, 31201

  • TDDC dba GI Alliance Research

    Mansfield, Texas, 76063

  • LCC Medical Research Institute, LLC

    Miami, Florida, 33126

  • Allied Biomedical Research Institute

    Miami, Florida, 33155

  • Gastro Health Partners, LLC

    New Albany, Indiana, 47150

  • NYU Inflammatory Bowel Disease Center

    New York, New York, 10016

  • Weill Cornell Medical College

    New York, New York, 10021

  • DiGiovanna Inst for Med Ed&Res

    North Massapequa, New York, 11758

  • Integrity Trials LLC

    Orlando, Florida, 32807

  • Digestive and Liver Center of Florida

    Orlando, Florida, 32825

  • Advanced Medical Research Center

    Port Orange, Florida, 32127

  • University Gastroenterology

    Providence, Rhode Island, 02904

  • Queens Village Medical Care

    Queens Village, New York, 11428

  • Stanford Medicine Outpatient Center

    Redwood City, California, 94063

  • Gastroenterology Consultants of SWVA

    Roanoke, Virginia, 24018

  • Gastroenterology Group Of Rochester, LLP

    Rochester, New York, 14618

  • Southern Star Research Institute, LLC.

    San Antonio, Texas, 78229

  • Mayo Clinic Hospital

    Scottsdale, Arizona, 85259

  • Louisiana Research Center - GastroIntestinal Associates

    Shreveport, Louisiana, 71105

  • Arizona Digestive Health, P.C (ADH)

    Sun City, Arizona, 85351

  • University of South Florida School of Medicine Morsani Center for Advanced Health Care

    Tampa, Florida, 33612

  • Guardian Angel Research Center, LLC

    Tampa, Florida, 33614

  • Santos Research Center, CORP

    Tampa, Florida, 33615

  • Baylor Scott and White Medical Center

    Temple, Texas, 76508

  • Tyler Research Institute, LLC

    Tyler, Texas, 75701

  • University of Texas Health Center at Tyler

    Tyler, Texas, 75708

  • Frontier Clinical Re search, LLC

    Uniontown, Pennsylvania, 15401

  • TDDC GI Alliance research Webster

    Webster, Texas, 77598

  • Gastro Intestinal Research Institute of Northern Ohio

    Westlake, Ohio, 44145

  • Cleveland Clinic Florida

    Weston, Florida, 33331

  • Kansas Gastroenterology, LLC under Clinical Trials Network

    Wichita, Kansas, 67226

Other trials in United States

Poland17 sites

  • Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi sp. z o.o.

    ?ód?, 93-357

  • Medical Center Kermed

    Bydgoszcz, 85-231

  • Szpital Miejski sw. Jana Paw?a II w Elblagu

    Elblag, 82-300

  • Osrodek Badan Klinicznych Bd Research

    I?awa, 14-200

  • MZ Badania Slowik Zymla Sp.j.

    Knurów, 44-190

  • Centrum Medyczne Promed

    Krakow, 31-513

  • Medrise sp z o.o

    Lublin, 20-582

  • EMC Instytut Medyczny SA

    Późna, 60-309

  • Gabinety Lekarskie Rivermed

    Późna, 61-441

  • Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa

    Poznan, 61-731

  • Endoskopia Sp. z o.o.

    Sopot, 81-756

  • Sonomed Sp. z o.o.

    Szczecin, 71-685

  • Centrum Zdrowia-MDM

    Warsaw, 00-189

  • Medon Clinical Research sp. z o.o

    Warsaw, 02-679

  • Vivamed Spolka Z Ograniczona Odpowiedzialnoscia

    Warsaw, 03-580

  • PlanetMed sp. z o.o.

    Wroc?aw, 52-210

  • Centrum Medyczne Oporow

    Wroclaw, 52-416

Other trials in Poland

China16 sites

  • Beijing No.6 Hospital

    Beijing, Beijing Municipality, 100007

  • Third Xiangya Hospital Centrel South University

    Changsha, 410013

  • West China Hospital of Sichuan University

    Chengdu, 610041

  • Guangzhou First People's Hospital

    Guangzhou, 510180

  • The second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510260

  • Sir Run Run Shaw Hospital Zhejiang University

    Hangzhou, 310016

  • Huizhou Central People's Hospital

    Huizhou, 516001

  • The First Affilliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032

  • The First Affiliate Hospital of Guangxi Medical University

    Nanning, 530021

  • The First Affiliated Hospital of Ningbo University

    Ningbo, 315000

  • The Affiliated Hospital of Medical College Qingdao University

    Qingdao, 266000

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, 200025

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

    Shanghai, 200092

  • Shengjing Hospital of China Medical University

    Shenyang, 110004

  • First Affiliated Hospital of Soochow University

    Suzhou, 215006

  • Zhongshan Hospital Xiamen University

    Xiamen, 361004

Other trials in China

India7 sites

  • SR Kalla Memorial Gastro & General Hospital

    Jaipur, Rajasthan, 302006

  • SMS Superspeciality Hospital

    Jaipur, Rajasthan, 302007

  • Kingsway Hospital

    Nagpur (urban), Maharashtra, 440001

  • MIDAS Multispeciality Hospital

    Nagpur (urban), Maharashtra, 440018

  • Yashoda Hospitals

    Secunderabad, Telangana, 500003

  • Surat Institute of Digestive Sciences Hospitals

    Surat, Gujarat, 395002

  • Gujarat Gastro and Vascular Hospital

    Surat, Gujarat, 395009

Other trials in India

Italy7 sites

  • Asst Degli Spedali Civili Di Brescia

    Brescia, Lombardy, 25123

  • IRCCS Ospedale San Raffaele

    Milan, Lombardy, 20132

  • Azienda Ospedaliera San Gerardo di Monza

    Monza MI, Lombardy, 20900

  • IRCCS Ospedale Sacro Cuore Don Calabria

    Negrar, Veneto, 37024

  • Policlinico Universitario Campus Biomedico Di Roma

    Rome, Lazio, 00128

  • Ospedale Isola Tiberina Gemelli

    Rome, Lazio, 00186

  • Istituto Clinico Humanitas

    Rozzano (MI), Lombardy, 20089

Other trials in Italy

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

Brazil5 sites

  • Newdata Clinical Trials

    Aracaju, Sergipe, 49055-000

  • CECIP - Centro de Estudos Clínicos do Interior Paulista

    Jaú, São Paulo, 17210-190

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-000

  • Centro Paulista de Investigacao Clinica - CEPIC

    São Paulo, São Paulo, 04266-010

  • Instituto Lobus Unimed Volta Redonda

    Volta Redonda, Rio de Janeiro, 27258-000

Other trials in Brazil

Canada5 sites

  • Barrie GI Associates

    Barrie, Ontario, L4M 7G1

  • London Health Sciences Centre Uni Campus

    London, Ontario, N6A 5A5

  • LDDI Clinical Trials Inc.

    London, Ontario, N6K 1M6

  • CIUSSS-de-l?Est-de-l?Île-de-Montréal

    Montreal, Quebec, H1T 2M4

  • TIDHI Innovation Inc.

    Toronto, Ontario, M6A 3B4

Other trials in Canada

France5 sites

  • CHU Tours - Hôpital Trousseau

    Chambray-lès-Tours, 37170

  • CHU Clermont Ferrand - Hôtel Dieu

    Clermont-Ferrand, 63000

  • Hôpital Henri Mondor

    Créteil, 94000

  • Polyclinique Grand Sud

    Nîmes, 30900

  • Hôpital de Brabois Adultes

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Hungary4 sites

  • Semmelweis Egyetem

    Budapest, 1082

  • Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont

    Debrecen, 4025

  • Fejer Varmegyei Szent György Egyetemi Oktatokorhaz

    Székesfehérvár, 8000

  • Vas-Oxy Egeszsegugyi Kft

    Szombathely, 9700

Other trials in Hungary

United Kingdom4 sites

  • Leicester General Hospital

    Leicester, LE5 4PW

  • Bronglais General Hospital

    Llanrhystud, SY23 1ER

  • King College Hospital NHS Foundation Trust

    London, SE5 9RS

  • Stepping Hill Hospital

    Stockport, SK2 7JE

Other trials in United Kingdom

Thailand3 sites

  • Division of Gastroenterology, Depart of Internal Med., Fac of Med., Chiang Mai University

    Chiang Mai, 50200

  • Burapha University Hospital

    Chon Buri, 20131

  • Sunpasitthiprasong Hospital

    Ubonratchathani, 34000

Other trials in Thailand

Argentina2 sites

  • Hospital Britanico

    Ciudad Autonoma Bs As, C1280AEB

  • Instituto Medico CER

    Quilmes, B1878DVB

Other trials in Argentina

Australia2 sites

  • Macquarie University Hospital

    Macquarie Park, New South Wales, 2109

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

Other trials in Australia

Belgium2 sites

  • CHU St Pierre (St Pierre)

    Brussels, 1000

  • Cliniques Universitaires St-Luc

    Brussels, 1200

Other trials in Belgium

Bulgaria2 sites

  • MC " Sveti Ivan Rilski Chudotvorets- 2010

    Plovdiv, 4003

  • "City Clinic UMHAC" EOOD

    Sofia, 1407

Other trials in Bulgaria

Czechia2 sites

  • Hepato-Gastroenterologie HK, s.r.o.

    Hradec Králové, 500 12

  • ISCARE a.s.

    Prague, 170 04

Other trials in Czechia

Israel2 sites

  • Soroka Medical Center

    Beersheba, 8410101

  • The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's Hospital

    Ramat Gan, 5265601

Other trials in Israel

Mexico2 sites

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

    Miguel Hidalgo, Mexico CITY (federal District), 01120

  • FAICIC S de R.L. de C.V

    Veracruz, 91900

Other trials in Mexico

Spain2 sites

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Austria1 site

  • Ordensklinikum Linz Barmherzige Schwestern

    Linz, 4010

Other trials in Austria

Chile1 site

  • Centro de Investigación Clínica UC-CICUC

    Santiago, 8330034

Other trials in Chile

Croatia1 site

  • Borzan Polyclinic

    Osijek, 31000

Other trials in Croatia

Denmark1 site

  • Ålborg Universitets Hospital

    Aalborg, 9000

Other trials in Denmark

Germany1 site

  • Medizinisches Zentrum Klinikum Lueneburg

    Lüneburg, 21339

Other trials in Germany

Netherlands1 site

  • ETZ Elisabeth

    Tilburg, 5022 GC

Other trials in Netherlands

Puerto Rico1 site

  • Klinical Investigations Group LLC

    San Juan, 00909

Other trials in Puerto Rico

Serbia1 site

  • General Hospital "Djordje Joanovic"

    Zrenjanin, 23000

Other trials in Serbia

Taiwan1 site

  • China Medical University Hospital

    Taichung, 40447

Other trials in Taiwan

About this study

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

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

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

    Participants will receive afimkibart IV followed by afimkibart subcutaneous SC injection.

  • PlaceboDrug

    Placebo matching IV afimkibart. Placebo matching SC afimkibart.

Study groups in NCT06588855
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

    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

Secondary outcomes (17)

  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: From 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. 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 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

  10. 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

  11. Change in Bowel Urgency

    Change in bowel urgency from baseline through Week 12. Bowel urgency is measured on a scale from 0 (None) to 4 (Severe).

    Measured: Baseline through Week 12

  12. Change in Abdominal Pain

    Change in abdominal pain from baseline through Week 12. Abdominal pain is measured on a scale from 0 (None) to 4 (Severe).

    Measured: Baseline through Week 12

  13. Change in Fatigue

    Change in fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) from baseline to Week 12. FACIT-Fatigue is a 13-item self-reported assessment of the level and impact of fatigue. The overall FACIT-Fatigue score ranges between 0 and 52, with higher scores associated with better quality of life concerns related to fatigue.

    Measured: Baseline to Week 12

  14. Change in Health-Related Quality of Life

    Change in Inflammatory Bowel Disease Questionnaire (IBDQ) score from baseline to Week 12. IBDQ is a 32-item self-reported assessment of health-related quality of life in participants with inflammatory bowel disease. The overall IBDQ score ranges from 32 to 224, with higher scores associated with better health-related quality of life.

    Measured: Baseline to Week 12

  15. Overall Change in UC Symptoms

    Patient Global Impression of Change (PGIC) from baseline to Weeks 2 and 12. PGIC measures overall change in ulcerative colitis symptoms from "Much better" to"Much worse".

    Measured: Baseline to Week 2 and Week 12

  16. Overall Severity in UC Symptoms

    Patient Global Impression of Severity (PGIS) from baseline to Weeks 2 and 12. PGIS measures severity of ulcerative colitis symptoms from "None" to "Very severe".

    Measured: Baseline to Week 2 and Week 12

  17. 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 30 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 start11 Dec 2024
  3. Primary completion29 Oct 2026 (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
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06588855
Sponsor's protocol ID
GA45330
Other IDs
2024-513015-27-00
Acronym
Ametrine-2
Status last verified
Oct 2026
First submitted
6 Sep 2024
Last updated
2 Oct 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 168 sites in 29 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 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 168 sites in United States, Poland, China, India, Italy and 24 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 (time frame: At Week 12). 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 NCT06588855.

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 2 Oct 2026.

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