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

NCT06588855 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: GA453302024-513015-27-00
• Study Type: interventional
• Target: 350
• Locations: 28 countries
• Sites: 166

Brief 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).

Conditions

Moderately to Severely Active Ulcerative Colitis

Outcome Measures

Primary Outcomes (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.

  At Week 12

Secondary Outcomes (17)

• Change in Partial Modified Mayo Score (pmMS)

  From baseline to Week 2

• Percentage of Participants with Endoscopic Improvement

  At Week 12

• Percentage of Participants with Endoscopic Remission

  At Week 12

• Percentage of Participants with Clinical Response

  At Week 12

• Percentage of Participants with Histologic Improvement

  At Week 12

Study Arms (2)

Afimkibart

EXPERIMENTAL

Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.

Drug: Afimkibart

Placebo

PLACEBO COMPARATOR

Participants will receive placebo IV followed by placebo SC.

Drug: Placebo

Interventions

Afimkibart DRUG

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

Also known as: PF-06480605, RVT-3101, RG6631, RO7790121

Afimkibart

Placebo DRUG

Placebo matching IV afimkibart. Placebo matching SC afimkibart.

Placebo

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (168)

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

Dothan, Alabama, 36305, United States

Location

Mayo Clinic Hospital

Scottsdale, Arizona, 85259, United States

Location

Arizona Digestive Health, P.C (ADH)

Sun City, Arizona, 85351, United States

Location

Om Research LLC

Apple Valley, California, 92307, United States

Location

Valley View Internal Medicine

Garden Grove, California, 92845, United States

Location

Gastro Care Associates

Lancaster, California, 93534, United States

Location

Stanford Medicine Outpatient Center

Redwood City, California, 94063, United States

Location

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907, United States

Location

Hi Tech and Global Research, LLC

Coral Gables, Florida, 33134, United States

Location

The Sister Life Research

Hialeah, Florida, 33013, United States

Location

LCC Medical Research Institute, LLC

Miami, Florida, 33126, United States

Location

Allied Biomedical Research Institute

Miami, Florida, 33155, United States

Location

Integrity Trials LLC

Orlando, Florida, 32807, United States

Location

Digestive and Liver Center of Florida

Orlando, Florida, 32825, United States

Location

Advanced Medical Research Center

Port Orange, Florida, 32127, United States

Location

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

Tampa, Florida, 33612, United States

Location

Guardian Angel Research Center, LLC

Tampa, Florida, 33614, United States

Location

Santos Research Center, CORP

Tampa, Florida, 33615, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Randomize Now, LLC

Atlanta, Georgia, 30308, United States

Location

Atlanta Gastroenterology Associates

Atlanta, Georgia, 30342, United States

Location

Gastroenterology Associates of Central Georgia

Macon, Georgia, 31201, United States

Location

Illinois Gastroenterology Group-Glenview powered by GI Alliance

Glenview, Illinois, 60026, United States

Location

GI Alliance - Gurnee

Gurnee, Illinois, 60031, United States

Location

Gastro Health Partners, LLC

New Albany, Indiana, 47150, United States

Location

Kansas Gastroenterology, LLC under Clinical Trials Network

Wichita, Kansas, 67226, United States

Location

One GI: GHP - Gastroenterology Health Partners Louisville

Louisville, Kentucky, 40218, United States

Location

Louisiana Research Center - GastroIntestinal Associates

Shreveport, Louisiana, 71105, United States

Location

Allied Gastrointestinal Associates, PA

Flowood, Mississippi, 39232, United States

Location

Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756, United States

Location

Ellipsis Research Group

Brooklyn, New York, 11215, United States

Location

NYU Inflammatory Bowel Disease Center

New York, New York, 10016, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

DiGiovanna Inst for Med Ed&Res

North Massapequa, New York, 11758, United States

Location

Queens Village Medical Care

Queens Village, New York, 11428, United States

Location

Gastroenterology Group Of Rochester, LLP

Rochester, New York, 14618, United States

Location

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

Charlotte, North Carolina, 28207, United States

Location

Omega Research North Carolina, LLC

Fuquay-Varina, North Carolina, 27526, United States

Location

Peters Medical Research (PMR), LLC

High Point, North Carolina, 27260, United States

Location

Dayton Gastroenterology, Inc.

Beavercreek, Ohio, 45440, United States

Location

University of Cincinnati Hospital

Cincinnati, Ohio, 45267, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio Gastroenterology Group

Columbus, Ohio, 43202, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Gastro Intestinal Research Institute of Northern Ohio

Westlake, Ohio, 44145, United States

Location

Frontier Clinical Re search, LLC

Uniontown, Pennsylvania, 15401, United States

Location

University Gastroenterology

Providence, Rhode Island, 02904, United States

Location

Gastroenterology Associates

Greenville, South Carolina, 29607, United States

Location

Gastro One

Cordova, Tennessee, 38018, United States

Location

Uni of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

GI Alliance

Garland, Texas, 75044, United States

Location

Amel Med LLC

Georgetown, Texas, 78628, United States

Location

Cano Medical Center

Harlingen, Texas, 78550, United States

Location

Texas Digestive Specialists

Harlingen, Texas, 78550, United States

Location

GI Alliance - Bay Area Gastroenterology

Lubbock, Texas, 79410, United States

Location

TDDC dba GI Alliance Research

Mansfield, Texas, 76063, United States

Location

Southern Star Research Institute, LLC.

San Antonio, Texas, 78229, United States

Location

Baylor Scott and White Medical Center

Temple, Texas, 76508, United States

Location

Tyler Research Institute, LLC

Tyler, Texas, 75701, United States

Location

University of Texas Health Center at Tyler

Tyler, Texas, 75708, United States

Location

TDDC GI Alliance research Webster

Webster, Texas, 77598, United States

Location

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, 23320, United States

Location

Emeritas Research Group

Lansdowne Town Center, Virginia, 20176, United States

Location

Gastroenterology Consultants of SWVA

Roanoke, Virginia, 24018, United States

Location

Hospital Britanico

Ciudad Autonoma Bs As, C1280AEB, Argentina

Location

Instituto Medico CER

Quilmes, B1878DVB, Argentina

Location

Macquarie University Hospital

Macquarie Park, New South Wales, 2109, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Ordensklinikum Linz Barmherzige Schwestern

Linz, 4010, Austria

Location

CHU St Pierre (St Pierre)

Brussels, 1000, Belgium

Location

Cliniques Universitaires St-Luc

Brussels, 1200, Belgium

Location

Instituto Lobus Unimed Volta Redonda

Volta Redonda, Rio de Janeiro, 27258-000, Brazil

Location

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90035-000, Brazil

Location

Newdata Clinical Trials

Aracaju, Sergipe, 49055-000, Brazil

Location

CECIP - Centro de Estudos Clínicos do Interior Paulista

Jaú, São Paulo, 17210-190, Brazil

Location

Centro Paulista de Investigacao Clinica - CEPIC

São Paulo, São Paulo, 04266-010, Brazil

Location

MC " Sveti Ivan Rilski Chudotvorets- 2010

Plovdiv, 4003, Bulgaria

Location

"City Clinic UMHAC" EOOD

Sofia, 1407, Bulgaria

Location

Barrie GI Associates

Barrie, Ontario, L4M 7G1, Canada

Location

London Health Sciences Centre Uni Campus

London, Ontario, N6A 5A5, Canada

Location

LDDI Clinical Trials Inc.

London, Ontario, N6K 1M6, Canada

Location

TIDHI Innovation Inc.

Toronto, Ontario, M6A 3B4, Canada

Location

CIUSSS-de-l?Est-de-l?Île-de-Montréal

Montreal, Quebec, H1T 2M4, Canada

Location

Centro de Investigación Clínica UC-CICUC

Santiago, 8330034, Chile

Location

Beijing No.6 Hospital

Beijing, Beijing Municipality, 100007, China

Location

The First Affilliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

Location

Third Xiangya Hospital Centrel South University

Changsha, 410013, China

Location

West China Hospital of Sichuan University

Chengdu, 610041, China

Location

Guangzhou First People's Hospital

Guangzhou, 510180, China

Location

The second Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510260, China

Location

Sir Run Run Shaw Hospital Zhejiang University

Hangzhou, 310016, China

Location

Huizhou Central People's Hospital

Huizhou, 516001, China

Location

The First Affiliate Hospital of Guangxi Medical University

Nanning, 530021, China

Location

The First Affiliated Hospital of Ningbo University

Ningbo, 315000, China

Location

The Affiliated Hospital of Medical College Qingdao University

Qingdao, 266000, China

Location

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, 200025, China

Location

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, 200092, China

Location

Shengjing Hospital of China Medical University

Shenyang, 110004, China

Location

First Affiliated Hospital of Soochow University

Suzhou, 215006, China

Location

Zhongshan Hospital Xiamen University

Xiamen, 361004, China

Location

Borzan Polyclinic

Osijek, 31000, Croatia

Location

Hepato-Gastroenterologie HK, s.r.o.

Hradec Králové, 500 12, Czechia

Location

ISCARE a.s.

Prague, 170 04, Czechia

Location

Ålborg Universitets Hospital

Aalborg, 9000, Denmark

Location

CHU Tours - Hôpital Trousseau

Chambray-lès-Tours, 37170, France

Location

CHU Clermont Ferrand - Hôtel Dieu

Clermont-Ferrand, 63000, France

Location

Hôpital Henri Mondor

Créteil, 94000, France

Location

Polyclinique Grand Sud

Nîmes, 30900, France

Location

Hôpital de Brabois Adultes

Vandœuvre-lès-Nancy, 54511, France

Location

Medizinisches Zentrum Klinikum Lueneburg

Lüneburg, 21339, Germany

Location

Semmelweis Egyetem

Budapest, 1082, Hungary

Location

Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont

Debrecen, 4025, Hungary

Location

Fejer Varmegyei Szent György Egyetemi Oktatokorhaz

Székesfehérvár, 8000, Hungary

Location

Vas-Oxy Egeszsegugyi Kft

Szombathely, 9700, Hungary

Location

Surat Institute of Digestive Sciences Hospitals

Surat, Gujarat, 395002, India

Location

Gujarat Gastro and Vascular Hospital

Surat, Gujarat, 395009, India

Location

Kingsway Hospital

Nagpur (urban), Maharashtra, 440001, India

Location

MIDAS Multispeciality Hospital

Nagpur (urban), Maharashtra, 440018, India

Location

SR Kalla Memorial Gastro & General Hospital

Jaipur, Rajasthan, 302006, India

Location

SMS Superspeciality Hospital

Jaipur, Rajasthan, 302007, India

Location

Yashoda Hospitals

Secunderabad, Telangana, 500003, India

Location

Soroka Medical Center

Beersheba, 8410101, Israel

Location

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

Ramat Gan, 5265601, Israel

Location

Policlinico Universitario Campus Biomedico Di Roma

Rome, Lazio, 00128, Italy

Location

Ospedale Isola Tiberina Gemelli

Rome, Lazio, 00186, Italy

Location

Asst Degli Spedali Civili Di Brescia

Brescia, Lombardy, 25123, Italy

Location

IRCCS Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

Location

Azienda Ospedaliera San Gerardo di Monza

Monza MI, Lombardy, 20900, Italy

Location

Istituto Clinico Humanitas

Rozzano (MI), Lombardy, 20089, Italy

Location

IRCCS Ospedale Sacro Cuore Don Calabria

Negrar, Veneto, 37024, Italy

Location

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

Miguel Hidalgo, Mexico CITY (federal District), 01120, Mexico

Location

FAICIC S de R.L. de C.V

Veracruz, 91900, Mexico

Location

ETZ Elisabeth

Tilburg, 5022 GC, Netherlands

Location

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

?ód?, 93-357, Poland

Location

Medical Center Kermed

Bydgoszcz, 85-231, Poland

Location

Szpital Miejski sw. Jana Paw?a II w Elblagu

Elblag, 82-300, Poland

Location

Osrodek Badan Klinicznych Bd Research

I?awa, 14-200, Poland

Location

MZ Badania Slowik Zymla Sp.j.

Knurów, 44-190, Poland

Location

Centrum Medyczne Promed

Krakow, 31-513, Poland

Location

Medrise sp z o.o

Lublin, 20-582, Poland

Location

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

Poznan, 61-731, Poland

Location

EMC Instytut Medyczny SA

Późna, 60-309, Poland

Location

Gabinety Lekarskie Rivermed

Późna, 61-441, Poland

Location

Endoskopia Sp. z o.o.

Sopot, 81-756, Poland

Location

Sonomed Sp. z o.o.

Szczecin, 71-685, Poland

Location

Centrum Zdrowia-MDM

Warsaw, 00-189, Poland

Location

Medon Clinical Research sp. z o.o

Warsaw, 02-679, Poland

Location

Vivamed Spolka Z Ograniczona Odpowiedzialnoscia

Warsaw, 03-580, Poland

Location

PlanetMed sp. z o.o.

Wroc?aw, 52-210, Poland

Location

Centrum Medyczne Oporow

Wroclaw, 52-416, Poland

Location

Hospital de Braga

Braga, 4710-243, Portugal

Location

Hospital da Luz Lisboa

Lisbon, 1500-650, Portugal

Location

Centro Hospitalar do Algarve - Hospital de Portimao

Portimão, 8500-338, Portugal

Location

Hospital de Sao Joao

Porto, 4202-451, Portugal

Location

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

Santa Maria da Feira, 4520-211, Portugal

Location

Hospital Sao Teotonio

Viseu, 3504-509, Portugal

Location

Klinical Investigations Group LLC

San Juan, 00909, Puerto Rico

Location

General Hospital "Djordje Joanovic"

Zrenjanin, 23000, Serbia

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

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

Chiang Mai, 50200, Thailand

Location

Burapha University Hospital

Chon Buri, 20131, Thailand

Location

Sunpasitthiprasong Hospital

Ubonratchathani, 34000, Thailand

Location

Leicester General Hospital

Leicester, LE5 4PW, United Kingdom

Location

Bronglais General Hospital

Llanrhystud, SY23 1ER, United Kingdom

Location

King College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

Stepping Hill Hospital

Stockport, SK2 7JE, United Kingdom

Location

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Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: December 11, 2024
• Primary Completion (Estimated): October 29, 2026
• Study Completion (Estimated): January 30, 2031
• Last Updated: October 2, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share

Locations

BR (5); CZ (2); HU (4); PR (1); SE (1); CN (16); CA (5); GB (4); CL (1); IT (7); IN (7); PL (17); AU (1); NL (1); ME (2); IL (2); CR (1); PT (6); AR (2); BU (2); TH (3); TW (1); ES (2); DE (1); US (64); BE (2); FR (5); DK (1)